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Mutalik C, Sharma S, Yougbaré S, Chen CY, Kuo TR. Nanoplasmonic Biosensors: A Comprehensive Overview and Future Prospects. Int J Nanomedicine 2025; 20:5817-5836. [PMID: 40356858 PMCID: PMC12067471 DOI: 10.2147/ijn.s521442] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2025] [Accepted: 04/16/2025] [Indexed: 05/15/2025] Open
Abstract
Recent nanotechnological advancements have resulted in a paradigm shift in biosensing applications through the advent of nanoplasmonic biosensors. These devices integrate nanomaterials with phenomena like surface plasmon resonance (SPR) and localized SPR (LSPR) to address the critical diagnostic and analytical needs across medicine, food safety, and drug discovery. Leveraging metals like gold and silver, these sensors exhibit enhanced optical and electronic properties, enabling the detection of biomolecules at ultralow concentrations. However, despite their transformative potential, challenges concerning stability, reproducibility, cost-efficiency, and scalability impede widespread implementation. This review offers a rigorous analysis of nanoplasmonic biosensors, emphasizing their underlying operational mechanisms and diverse applications. It also delves into design paradigms, fabrication protocols, and optimization strategies while concurrently examining prevailing challenges and prospective advancements. Furthermore, it highlights emerging trends, such as hybrid plasmonic nanostructures, conferring advantages in miniaturization, automation, and high-throughput analysis, thereby establishing a robust foundation for future innovation in the field.
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Affiliation(s)
- Chinmaya Mutalik
- Graduate Institute of Nanomedicine and Medical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, 11031, Taiwan
- Center for Airborne Infection & Transmission Science, Tulane University School of Medicine, New Orleans, LA, 70112, USA
| | - Shashwat Sharma
- International Ph.D. Program in Medicine, College of Medicine, Taipei Medical University, Taipei, 11031, Taiwan
| | - Sibidou Yougbaré
- Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO), Nanoro, BP 21811, Burkina Faso
| | - Chih-Yu Chen
- Department of Orthopedics, Shuang Ho Hospital, Taipei Medical University, New Taipei City, 23561, Taiwan
- International Ph.D. Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, 11031, Taiwan
- School of Biomedical Engineering, Taipei Medical University, Taipei, 11031, Taiwan
| | - Tsung-Rong Kuo
- Graduate Institute of Nanomedicine and Medical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, 11031, Taiwan
- International Ph.D. Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, 11031, Taiwan
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2
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Luo S, Yin L, Liu X, Wang X. Advances in Virus Biorecognition and Detection Techniques for the Surveillance and Prevention of Infectious Diseases. BIOSENSORS 2025; 15:198. [PMID: 40136995 PMCID: PMC11940537 DOI: 10.3390/bios15030198] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 02/23/2025] [Revised: 03/14/2025] [Accepted: 03/18/2025] [Indexed: 03/27/2025]
Abstract
Viral infectious diseases pose a serious threat to global public health due to their high transmissibility, rapid mutation rates, and limited treatment options. Recent outbreaks of diseases such as plague, monkeypox, avian influenza, and coronavirus disease 2019 (COVID-19) have underscored the urgent need for efficient diagnostic and surveillance technologies. Focusing on viral infectious diseases that seriously threaten human health, this review summarizes and analyzes detection techniques from the perspective of combining viral surveillance and prevention advice, and discusses applications in improving diagnostic sensitivity and specificity. One of the major innovations of this review is the systematic integration of advanced biorecognition and detection technologies, such as bionanosensors, rapid detection test strips, and microfluidic platforms, along with the exploration of artificial intelligence in virus detection. These technologies address the limitations of traditional methods and enable the real-time monitoring and early warning of viral outbreaks. By analyzing the application of these technologies in the detection of pathogens, new insights are provided for the development of next-generation diagnostic tools to address emerging and re-emerging viral threats. In addition, we analyze the current progress of developed vaccines, combining virus surveillance with vaccine research to provide new ideas for future viral disease prevention and control and vaccine development, and call for global attention and the development of new disease prevention and detection technologies.
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Affiliation(s)
- Shuwen Luo
- State Key Laboratory of Digital Medical Engineering, Jiangsu Key Laboratory for Biomaterials and Devices, School of Biological Science and Medical Engineering, Southeast University, Nanjing 210096, China;
- Key Laboratory of Environmental Medicine Engineering, Ministry of Education, School of Public Health, Southeast University, Nanjing 210009, China;
| | - Lihong Yin
- Key Laboratory of Environmental Medicine Engineering, Ministry of Education, School of Public Health, Southeast University, Nanjing 210009, China;
| | - Xiaohui Liu
- State Key Laboratory of Digital Medical Engineering, Jiangsu Key Laboratory for Biomaterials and Devices, School of Biological Science and Medical Engineering, Southeast University, Nanjing 210096, China;
| | - Xuemei Wang
- State Key Laboratory of Digital Medical Engineering, Jiangsu Key Laboratory for Biomaterials and Devices, School of Biological Science and Medical Engineering, Southeast University, Nanjing 210096, China;
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3
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Liustrovaite V, Ratautaite V, Ramanaviciene A, Ramanavicius A. Detection of the SARS-CoV-2 nucleoprotein by electrochemical biosensor based on molecularly imprinted polypyrrole formed on self-assembled monolayer. Biosens Bioelectron 2025; 272:117092. [PMID: 39787822 DOI: 10.1016/j.bios.2024.117092] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2024] [Revised: 12/12/2024] [Accepted: 12/21/2024] [Indexed: 01/12/2025]
Abstract
Herein, we report the development and characterisation of an electrochemical biosensor with a polypyrrole (Ppy)-based molecularly imprinted polymer (MIP) for the serological detection of the recombinant nucleocapsid protein of SARS-CoV-2 (rN). The electrochemical biosensor utilises a Ppy-based MIP formed on a self-assembled monolayer (SAM) at the gold interface to enhance Ppy layer stability on the screen-printed electrode (SPE). Electrochemical impedance spectroscopy (EIS) and square wave voltammetry (SWV) were employed for the electrochemical characterisation of screen-printed gold electrodes (SPGEs) modified with MIP or non-imprinted polymer (NIP) layers. Removing the rN protein template from the MIP layer increased electron transfer and decreased impedance, indicating the specificity of molecular imprinting. The electrochemical biosensor with a Ppy-based MIP exhibited higher sensitivity than the NIP counterpart, demonstrating its potential for selective rN protein detection. The limit of detection 0.4 nM and 0.2 nM and the limit of quantification 1.3 nM and 0.66 nM values obtained through SWV and EIS, respectively, highlight the biosensor's ability to detect low target protein concentrations. The specificity test confirmed minimal nonspecific binding, reinforcing the reliability of the novel electrochemical sensor with a Ppy-based MIP.
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Affiliation(s)
- Viktorija Liustrovaite
- NanoTechnas - Center of Nanotechnology and Materials Science, Institute of Chemistry, Faculty of Chemistry and Geosciences, Vilnius University (VU), Naugarduko St. 24, LT-03225, Vilnius, Lithuania; Department of Physical Chemistry, Institute of Chemistry, Faculty of Chemistry and Geosciences, Vilnius University (VU), Naugarduko St. 24, LT-03225, Vilnius, Lithuania
| | - Vilma Ratautaite
- Department of Physical Chemistry, Institute of Chemistry, Faculty of Chemistry and Geosciences, Vilnius University (VU), Naugarduko St. 24, LT-03225, Vilnius, Lithuania; Department of Nanotechnology, State Research Institute Center for Physical and Technological Sciences (FTMC), Sauletekio Ave. 3, LT-10257, Vilnius, Lithuania
| | - Almira Ramanaviciene
- NanoTechnas - Center of Nanotechnology and Materials Science, Institute of Chemistry, Faculty of Chemistry and Geosciences, Vilnius University (VU), Naugarduko St. 24, LT-03225, Vilnius, Lithuania
| | - Arunas Ramanavicius
- Department of Physical Chemistry, Institute of Chemistry, Faculty of Chemistry and Geosciences, Vilnius University (VU), Naugarduko St. 24, LT-03225, Vilnius, Lithuania; Department of Nanotechnology, State Research Institute Center for Physical and Technological Sciences (FTMC), Sauletekio Ave. 3, LT-10257, Vilnius, Lithuania.
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4
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Jung J, Dreyer KS, Dray KE, Muldoon JJ, George J, Shirman S, Cabezas MD, d’Aquino AE, Verosloff MS, Seki K, Rybnicky GA, Alam KK, Bagheri N, Jewett MC, Leonard JN, Mangan NM, Lucks JB. Developing, Characterizing, and Modeling CRISPR-Based Point-of-Use Pathogen Diagnostics. ACS Synth Biol 2025; 14:129-147. [PMID: 39670656 PMCID: PMC11744932 DOI: 10.1021/acssynbio.4c00469] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2024] [Revised: 11/12/2024] [Accepted: 11/13/2024] [Indexed: 12/14/2024]
Abstract
Recent years have seen intense interest in the development of point-of-care nucleic acid diagnostic technologies to address the scaling limitations of laboratory-based approaches. Chief among these are combinations of isothermal amplification approaches with CRISPR-based detection and readouts of target products. Here, we contribute to the growing body of rapid, programmable point-of-care pathogen tests by developing and optimizing a one-pot NASBA-Cas13a nucleic acid detection assay. This test uses the isothermal amplification technique NASBA to amplify target viral nucleic acids, followed by the Cas13a-based detection of amplified sequences. We first demonstrate an in-house formulation of NASBA that enables the optimization of individual NASBA components. We then present design rules for NASBA primer sets and LbuCas13a guide RNAs for the fast and sensitive detection of SARS-CoV-2 viral RNA fragments, resulting in 20-200 aM sensitivity. Finally, we explore the combination of high-throughput assay condition screening with mechanistic ordinary differential equation modeling of the reaction scheme to gain a deeper understanding of the NASBA-Cas13a system. This work presents a framework for developing a mechanistic understanding of reaction performance and optimization that uses both experiments and modeling, which we anticipate will be useful in developing future nucleic acid detection technologies.
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Affiliation(s)
- Jaeyoung
K. Jung
- Department
of Chemical and Biological Engineering, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Water Research, Northwestern University, Evanston, Illinois 60208, United States
| | - Kathleen S. Dreyer
- Department
of Chemical and Biological Engineering, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
| | - Kate E. Dray
- Department
of Chemical and Biological Engineering, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
| | - Joseph J. Muldoon
- Department
of Medicine, University of California, San
Francisco, San Francisco, California 94143, United States
- Gladstone-UCSF
Institute of Genomic Immunology, San Francisco, California 94158, United States
| | - Jithin George
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Department
of Engineering Sciences and Applied Mathematics, Northwestern University, Evanston, Illinois 60208, United States
- NSF-Simons
Center for Quantitative Biology, Northwestern
University, Evanston, Illinois 60208, United States
| | - Sasha Shirman
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- NSF-Simons
Center for Quantitative Biology, Northwestern
University, Evanston, Illinois 60208, United States
| | - Maria D. Cabezas
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Department
of Biomedical Engineering, Northwestern
University, Evanston, Illinois 60208, United States
| | - Anne E. d’Aquino
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Stemloop,
Inc., Evanston, Illinois 60201, United States
- Interdisciplinary
Biological Sciences Program, Northwestern
University, Evanston, Illinois 60208, United States
| | - Matthew S. Verosloff
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Interdisciplinary
Biological Sciences Program, Northwestern
University, Evanston, Illinois 60208, United States
| | - Kosuke Seki
- Department
of Chemical and Biological Engineering, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
| | - Grant A. Rybnicky
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Interdisciplinary
Biological Sciences Program, Northwestern
University, Evanston, Illinois 60208, United States
- Chemistry
of Life Processes Institute, Northwestern
University, Evanston, Illinois 60208, United States
| | | | - Neda Bagheri
- Department
of Chemical and Biological Engineering, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Interdisciplinary
Biological Sciences Program, Northwestern
University, Evanston, Illinois 60208, United States
- Departments
of Biology and Chemical Engineering, University
of Washington, Seattle, Washington 98195, United States
| | - Michael C. Jewett
- Department
of Chemical and Biological Engineering, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Department
of Bioengineering, Stanford University, Stanford, California 94305, United States
| | - Joshua N. Leonard
- Department
of Chemical and Biological Engineering, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Interdisciplinary
Biological Sciences Program, Northwestern
University, Evanston, Illinois 60208, United States
| | - Niall M. Mangan
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Department
of Engineering Sciences and Applied Mathematics, Northwestern University, Evanston, Illinois 60208, United States
- NSF-Simons
Center for Quantitative Biology, Northwestern
University, Evanston, Illinois 60208, United States
| | - Julius B. Lucks
- Department
of Chemical and Biological Engineering, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Synthetic Biology, Northwestern University, Evanston, Illinois 60208, United States
- Center
for Water Research, Northwestern University, Evanston, Illinois 60208, United States
- Chemistry
of Life Processes Institute, Northwestern
University, Evanston, Illinois 60208, United States
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Ding X, Murakami M, Wang J, Inoue H, Kiwa T. Microdetection of Nucleocapsid Proteins via Terahertz Chemical Microscope Using Aptamers. SENSORS (BASEL, SWITZERLAND) 2024; 24:7382. [PMID: 39599157 PMCID: PMC11598353 DOI: 10.3390/s24227382] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/25/2024] [Revised: 11/12/2024] [Accepted: 11/16/2024] [Indexed: 11/29/2024]
Abstract
In the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several methods have been employed, including the detection of viral ribonucleic acid (RNA), nucleocapsid (N) proteins, spike proteins, and antibodies. RNA detection, primarily through polymerase chain reaction tests, targets the viral genetic material, whereas antigen tests detect N and spike proteins to identify active infections. In addition, antibody tests are performed to measure the immune response, indicating previous exposure or vaccination. Here, we used the developed terahertz chemical microscope (TCM) to detect different concentrations of N protein in solution by immobilizing aptamers on a semiconductor substrate (sensing plate) and demonstrated that the terahertz amplitude varies as the concentration of N proteins increases, exhibiting a highly linear relationship with a coefficient of determination (R2 = 0.9881), indicating that a quantitative measurement of N proteins is achieved. By optimizing the reaction conditions, we confirmed that the amplitude of the terahertz wave was independent of the solution volume. Consequently, trace amounts (0.5 μL) of the N protein were successfully detected, and the detection process only took 10 min. Therefore, this study is expected to develop a rapid and sensitive method for the detection and observation of the SARS-CoV-2 virus at a microdetection level. It is anticipated that this research will significantly contribute to reducing the spread of novel infectious diseases in the future.
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Affiliation(s)
- Xue Ding
- Graduate School of Interdisciplinary Science and Engineering in Health Systems, Okayama University, Okayama 700-8530, Japan; (X.D.); (M.M.); (J.W.)
| | - Mana Murakami
- Graduate School of Interdisciplinary Science and Engineering in Health Systems, Okayama University, Okayama 700-8530, Japan; (X.D.); (M.M.); (J.W.)
| | - Jin Wang
- Graduate School of Interdisciplinary Science and Engineering in Health Systems, Okayama University, Okayama 700-8530, Japan; (X.D.); (M.M.); (J.W.)
| | - Hirofumi Inoue
- Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama University Hospital, Okayama 700-8558, Japan;
| | - Toshihiko Kiwa
- Graduate School of Interdisciplinary Science and Engineering in Health Systems, Okayama University, Okayama 700-8530, Japan; (X.D.); (M.M.); (J.W.)
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6
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Aga AM, Mulugeta D, Gebreegziabxier A, Mohammed J, Alemu A, Tesera Y, Mulugeta F, Gidisa B, Bulti J, Tadesse G, Tadesse Woldemariyam F, Nigussie D. Correlation of COVID-19 vaccination and RT-PCR ct value among cases in Addis Ababa, Ethiopia: implication for future preparedness. BMC Infect Dis 2024; 24:1127. [DOI: https:/bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-024-10061-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/29/2024] [Accepted: 10/04/2024] [Indexed: 05/26/2025] Open
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7
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Aga AM, Mulugeta D, Gebreegziabxier A, Mohammed J, Alemu A, Tesera Y, Mulugeta F, Gidisa B, Bulti J, Tadesse G, Tadesse Woldemariyam F, Nigussie D. Correlation of COVID-19 vaccination and RT-PCR ct value among cases in Addis Ababa, Ethiopia: implication for future preparedness. BMC Infect Dis 2024; 24:1127. [PMID: 39385106 PMCID: PMC11465663 DOI: 10.1186/s12879-024-10061-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/29/2024] [Accepted: 10/04/2024] [Indexed: 10/11/2024] Open
Abstract
BACKGROUND The COVID-19 disease requires accurate diagnosis to effectively manage infection rates and disease progression. The study aims to assess the relationship between vaccination status and RT-PCR cycle threshold (Ct) values by comparing clinical, RDT and RT-PCR results. METHODS A total of 453 suspected COVID-19 cases were included in this study. Nasopharyngeal swabs were collected for both RDT and RT-PCR testing, with RDTs conducted on-site and RT-PCR at the Ethiopian Public Health Institute (EPHI) genomics laboratory. Detailed clinical, RDT, and RT-PCR results were analyzed. Data analysis included descriptive statistics, cross-tabulation, and Chi-Square tests to investigate the connections between diagnostic outcomes and vaccination status, with a focusing on Ct values. RESULTS RDT results showed 34.0% negative and 65.8% positive, while RT-PCR results indicated 35.8% negative and 64.2% positive cases. The discrepancies between RDT and RT-PCR results emphasize the importance of thorough testing. No significant association was found between vaccination status and viral load, as indicated by Ct values. Among RT-PCR positive cases, 49.8% had been vaccinated, suggesting challenges in interpreting results among vaccinated individuals. Further analysis revealed that vaccination (first or second dose) had minimal impact on Ct values, indicating limited influence of vaccination status on viral load dynamics in infected individuals. CONCLUSIONS The study highlights the significant differences between RDT and RT-PCR outcomes, underscoring the need for a comprehensive testing approach. Additionally, the findings suggest that vaccination status does not significantly impact RT-PCR Ct values, complicating the interpretation of diagnostic results in vaccinated individuals, especially in breakthrough infections and potential false positives.
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Affiliation(s)
- Abebe M Aga
- Armauer Hansen Research Institute, Addis Ababa, Ethiopia.
| | | | | | - Jemal Mohammed
- Armauer Hansen Research Institute, Addis Ababa, Ethiopia
| | - Anberber Alemu
- Armauer Hansen Research Institute, Addis Ababa, Ethiopia
| | | | | | - Bedasa Gidisa
- Armauer Hansen Research Institute, Addis Ababa, Ethiopia
| | - Jaleta Bulti
- Ethiopian Public Health Institute, Addis Ababa, Ethiopia
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8
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Fujiuchi K, Aoki N, Ohtake T, Iwashita T, Kawasaki H. Transitions in Immunoassay Leading to Next-Generation Lateral Flow Assays and Future Prospects. Biomedicines 2024; 12:2268. [PMID: 39457581 PMCID: PMC11504701 DOI: 10.3390/biomedicines12102268] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2024] [Revised: 10/03/2024] [Accepted: 10/04/2024] [Indexed: 10/28/2024] Open
Abstract
In the field of clinical testing, the traditional focus has been on the development of large-scale analysis equipment designed to process high volumes of samples with fully automatic and high-sensitivity measurements. However, there has been a growing demand in recent years for the development of analytical reagents tailored to point-of-care testing (POCT), which does not necessitate a specific location or specialized operator. This trend is epitomized using the lateral flow assay (LFA), which became a cornerstone during the 2019 pandemic due to its simplicity, speed of delivering results-within about 10 min from minimal sample concentrations-and user-friendly design. LFAs, with their paper-based construction, combine cost-effectiveness with ease of disposal, addressing both budgetary and environmental concerns comprehensively. Despite their compact size, LFAs encapsulate a wealth of technological ingenuity, embodying years of research and development. Current research is dedicated to further evolving LFA technology, paving the way for the next generation of diagnostic devices. These advancements aim to redefine accessibility, empower individuals, and enhance responsiveness to public health challenges. The future of LFAs, now unfolding, promises even greater integration into routine health management and emergency responses, underscoring their critical role in the evolution of decentralized and patient-centric healthcare solutions. In this review, the historical development of LFA and several of the latest LFA technologies using catalytic amplification, surface-enhanced Raman scattering, heat detection, electron chemical detections, magnetoresistance, and detection of reflected electrons detection are introduced to inspire readers for future research and development.
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Affiliation(s)
- Koyu Fujiuchi
- NanoSuit Research Laboratory, Institute of Photonics Medicine, Division of Preeminent Bioimaging Research, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan;
- Research and Development Department, TAUNS Laboratories, Inc., Izunokuni-shi 410-2325, Japan; (N.A.); (T.O.)
| | - Noriko Aoki
- Research and Development Department, TAUNS Laboratories, Inc., Izunokuni-shi 410-2325, Japan; (N.A.); (T.O.)
| | - Tetsurou Ohtake
- Research and Development Department, TAUNS Laboratories, Inc., Izunokuni-shi 410-2325, Japan; (N.A.); (T.O.)
| | - Toshihide Iwashita
- Department of Regenerative and Infectious Pathology, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan;
| | - Hideya Kawasaki
- NanoSuit Research Laboratory, Institute of Photonics Medicine, Division of Preeminent Bioimaging Research, Hamamatsu University School of Medicine, Hamamatsu 431-3125, Japan;
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9
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Jung JK, Dreyer KS, Dray KE, Muldoon JJ, George J, Shirman S, Cabezas MD, D’Aquino AE, Verosloff MS, Seki K, Rybnicky GA, Alam KK, Bagheri N, Jewett MC, Leonard JN, Mangan NM, Lucks JB. Developing, characterizing and modeling CRISPR-based point-of-use pathogen diagnostics. BIORXIV : THE PREPRINT SERVER FOR BIOLOGY 2024:2024.07.03.601853. [PMID: 39005318 PMCID: PMC11244977 DOI: 10.1101/2024.07.03.601853] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 07/16/2024]
Abstract
Recent years have seen intense interest in the development of point-of-care nucleic acid diagnostic technologies to address the scaling limitations of laboratory-based approaches. Chief among these are combinations of isothermal amplification approaches with CRISPR-based detection and readouts of target products. Here, we contribute to the growing body of rapid, programmable point-of-care pathogen tests by developing and optimizing a one-pot NASBA-Cas13a nucleic acid detection assay. This test uses the isothermal amplification technique NASBA to amplify target viral nucleic acids, followed by Cas13a-based detection of amplified sequences. We first demonstrate an in-house formulation of NASBA that enables optimization of individual NASBA components. We then present design rules for NASBA primer sets and LbuCas13a guide RNAs for fast and sensitive detection of SARS-CoV-2 viral RNA fragments, resulting in 20 - 200 aM sensitivity without any specialized equipment. Finally, we explore the combination of high-throughput assay condition screening with mechanistic ordinary differential equation modeling of the reaction scheme to gain a deeper understanding of the NASBA-Cas13a system. This work presents a framework for developing a mechanistic understanding of reaction performance and optimization that uses both experiments and modeling, which we anticipate will be useful in developing future nucleic acid detection technologies.
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Affiliation(s)
- Jaeyoung K. Jung
- Department of Chemical and Biological Engineering, Northwestern University (Evanston IL, USA)
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Center for Water Research, Northwestern University (Evanston, IL, USA)
| | - Kathleen S. Dreyer
- Department of Chemical and Biological Engineering, Northwestern University (Evanston IL, USA)
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
| | - Kate E. Dray
- Department of Chemical and Biological Engineering, Northwestern University (Evanston IL, USA)
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
| | - Joseph J. Muldoon
- Department of Medicine, University of California, San Francisco (San Francisco, CA, USA)
- Gladstone-UCSF Institute of Genomic Immunology (San Francisco, CA, USA)
| | - Jithin George
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Department of Engineering Sciences and Applied Mathematics, Northwestern University (Evanston, IL, USA)
- NSF-Simons Center for Quantitative Biology, Northwestern University (Evanston, IL, USA)
| | - Sasha Shirman
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- NSF-Simons Center for Quantitative Biology, Northwestern University (Evanston, IL, USA)
| | - Maria D. Cabezas
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Department of Biomedical Engineering, Northwestern University (Evanston, IL, USA)
| | - Anne E. D’Aquino
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Stemloop, Inc. (Evanston, IL, USA)
- Interdisciplinary Biological Sciences Program, Northwestern University (Evanston, IL, USA)
| | - Matthew S. Verosloff
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Interdisciplinary Biological Sciences Program, Northwestern University (Evanston, IL, USA)
| | - Kosuke Seki
- Department of Chemical and Biological Engineering, Northwestern University (Evanston IL, USA)
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
| | - Grant A. Rybnicky
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Interdisciplinary Biological Sciences Program, Northwestern University (Evanston, IL, USA)
- Chemistry of Life Processes Institute, Northwestern University (Evanston, IL, USA)
| | | | - Neda Bagheri
- Department of Chemical and Biological Engineering, Northwestern University (Evanston IL, USA)
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Interdisciplinary Biological Sciences Program, Northwestern University (Evanston, IL, USA)
- Departments of Biology and Chemical Engineering, University of Washington (Seattle, WA, USA)
| | - Michael C. Jewett
- Department of Chemical and Biological Engineering, Northwestern University (Evanston IL, USA)
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Department of Bioengineering, Stanford University (Stanford, CA)
| | - Joshua N. Leonard
- Department of Chemical and Biological Engineering, Northwestern University (Evanston IL, USA)
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Interdisciplinary Biological Sciences Program, Northwestern University (Evanston, IL, USA)
| | - Niall M. Mangan
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Department of Engineering Sciences and Applied Mathematics, Northwestern University (Evanston, IL, USA)
- NSF-Simons Center for Quantitative Biology, Northwestern University (Evanston, IL, USA)
| | - Julius B. Lucks
- Department of Chemical and Biological Engineering, Northwestern University (Evanston IL, USA)
- Center for Synthetic Biology, Northwestern University (Evanston, IL, USA)
- Center for Water Research, Northwestern University (Evanston, IL, USA)
- Chemistry of Life Processes Institute, Northwestern University (Evanston, IL, USA)
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10
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Ma Y, Zhang Q, Shan Z, Chen Y, Chen Y, Pan X, Huang Y. Pregnancy outcomes in women with severe acute respiratory syndrome coronavirus 2 reinfections compared to those with a single infection: a retrospective cohort study. BMC Pregnancy Childbirth 2024; 24:459. [PMID: 38961348 PMCID: PMC11223318 DOI: 10.1186/s12884-024-06657-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/26/2024] [Accepted: 06/25/2024] [Indexed: 07/05/2024] Open
Abstract
BACKGROUND To assess pregnancy outcomes in women with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reinfection. METHODS This was a retrospective cohort study that included pregnant women who contracted coronavirus disease 2019 (COVID-19) once or twice during pregnancy and who gave birth between 1 October 2022 and 15 August 2023 in Shanghai First Maternity and Infant Hospital (Shanghai, China). We collected their clinical data and compared the frequency of adverse pregnancy outcomes between the reinfection group and the primary infection group, such as preterm birth, fetal growth restriction (FGR), hypertensive disorders of pregnancy (HDP), common pregnancy-related conditions, birth weight, and neonatal unit admission. RESULTS We observed a 7.7% reinfection rate among the 1,405 women who contracted COVID-19 during pregnancy. There were no significant differences in the frequency of preterm birth, FGR, HDP, other common pregnancy-related conditions, birth weight, or rate of neonatal unit admission between the reinfection and single infection groups. All our participants were unvaccinated, and all had mild symptoms. CONCLUSION Our study showed no significant association between SARS-CoV-2 reinfection and adverse pregnancy outcomes.
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Affiliation(s)
- Yan Ma
- Shanghai Key Laboratory of Maternal Fetal Medicine, Shanghai Institute of Maternal-Fetal Medicine and Gynecologic Oncology, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, 536 Changle Road, Jingan District, Shanghai, 200040, China
| | - Qingxia Zhang
- Department of Obstetrics and Gynecology, China-Japan Friendship Hospital, 2 Yinghuayuan East Streat, Chaoyang District, 100029, Beijing, China
| | - Zhenli Shan
- Shanghai Key Laboratory of Maternal Fetal Medicine, Shanghai Institute of Maternal-Fetal Medicine and Gynecologic Oncology, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, 536 Changle Road, Jingan District, Shanghai, 200040, China
| | - Yanting Chen
- Department of Obstetrics and Gynecology, China-Japan Friendship Hospital, 2 Yinghuayuan East Streat, Chaoyang District, 100029, Beijing, China
| | - Yan Chen
- Department of Obstetrics and Gynecology, North China University of Science And Technology Affiliated Hospital, 063099, Tangshan, Hebei Province, China
| | - Xiaoyu Pan
- Department of Obstetrics and Gynecology, China-Japan Friendship Hospital, 2 Yinghuayuan East Streat, Chaoyang District, 100029, Beijing, China.
| | - Yiying Huang
- Shanghai Key Laboratory of Maternal Fetal Medicine, Shanghai Institute of Maternal-Fetal Medicine and Gynecologic Oncology, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, 536 Changle Road, Jingan District, Shanghai, 200040, China.
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11
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Yin J, Liu H, Chen Y, Zhou J, Liu Y, Liang Z, Zhu X, Liu H, Ding P, Liu E, Zhang Y, Wu S, Wang A. Development and application of a high-sensitivity immunochromatographic test strip for detecting pseudorabies virus. Front Microbiol 2024; 15:1399123. [PMID: 38765685 PMCID: PMC11099248 DOI: 10.3389/fmicb.2024.1399123] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/11/2024] [Accepted: 04/16/2024] [Indexed: 05/22/2024] Open
Abstract
Introduction Pseudorabies (PR) is a multi-animal comorbid disease caused by pseudorabies virus (PRV), which are naturally found in pigs. At the end of 2011, the emergence of PRV variant strains in many provinces in China had caused huge economic losses to pig farms. Rapid detection diagnosis of pigs infected with the PRV variant helps prevent outbreaks of PR. The immunochromatography test strip with colloidal gold nanoparticles is often used in clinical testing due to its low cost and high throughput. Methods This study was designed to produce monoclonal antibodies targeting PRV through immunization of mice using the eukaryotic system to express the gE glycoprotein. Subsequently, paired monoclonal antibodies were screened based on their sensitivity and specificity for use in the preparation of test strips. Results and discussion The strip prepared in this study was highly specific, only PRV was detected, and there was no cross-reactivity with glycoprotein gB, glycoprotein gC, glycoprotein gD, and glycoprotein gE of herpes simplex virus and varicellazoster virus, porcine epidemic diarrhea virus, Senecavirus A, classical swine fever virus, porcine reproductive and respiratory syndrome virus, and porcine parvovirus. Moreover, it demonstrated high sensitivity with a detection limit of 1.336 × 103 copies/μL (the number of viral genome copies per microliter); the coincidence rate with the RT-PCR detection method was 96.4%. The strip developed by our laboratory provides an effective method for monitoring PRV infection and controlling of PR vaccine quality.
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Affiliation(s)
- Jiajia Yin
- Longhu Laboratory, Zhengzhou, China
- School of Life Sciences, Zhengzhou University, Zhengzhou, China
| | - Huimin Liu
- Longhu Laboratory, Zhengzhou, China
- College of Basic Science, Zhengzhou University of Technology, Zhengzhou, Henan, China
| | - Yumei Chen
- Longhu Laboratory, Zhengzhou, China
- School of Life Sciences, Zhengzhou University, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Jingming Zhou
- Longhu Laboratory, Zhengzhou, China
- School of Life Sciences, Zhengzhou University, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Yankai Liu
- Longhu Laboratory, Zhengzhou, China
- School of Life Sciences, Zhengzhou University, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Zhenglun Liang
- Longhu Laboratory, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Xifang Zhu
- Longhu Laboratory, Zhengzhou, China
- School of Life Sciences, Zhengzhou University, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Hongliang Liu
- Longhu Laboratory, Zhengzhou, China
- School of Life Sciences, Zhengzhou University, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Peiyang Ding
- Longhu Laboratory, Zhengzhou, China
- School of Life Sciences, Zhengzhou University, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Enping Liu
- Longhu Laboratory, Zhengzhou, China
- School of Life Sciences, Zhengzhou University, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Ying Zhang
- Longhu Laboratory, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Sixuan Wu
- Longhu Laboratory, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
| | - Aiping Wang
- Longhu Laboratory, Zhengzhou, China
- School of Life Sciences, Zhengzhou University, Zhengzhou, China
- Henan Provincial Key Laboratory of Immunobiology, Zhengzhou, China
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12
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Liu Y, Li J, Xiao Z, Wu T, Zhou C, Zhou J. Microstructure-Driven Self-Transport and Convection of Water on Membrane Surface for Ultra-Fast, Highly Sensitive, Low-Cost Lateral-Flow Assays. SMALL (WEINHEIM AN DER BERGSTRASSE, GERMANY) 2024; 20:e2309956. [PMID: 38145329 DOI: 10.1002/smll.202309956] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/01/2023] [Revised: 12/02/2023] [Indexed: 12/26/2023]
Abstract
Lateral-flow assay (LFA) is one of the most commonly used detection technologies, in which the chromatographic membranes are currently used as the lateral-flow membrane (e.g., nitrocellulose membrane, NC Mem). However, several disadvantages of existing chromatographic membranes limit the performance of LFA, including relatively low flow velocity of sample solution and relatively more residuals of sample on membrane, which increase detection time and detection noise. Herein, a surface structure membrane (SS Mem) is proposed, which enables fast self-transport of water with a convection manner and realizes low residuals of sample on membrane surface after the flow. On SS Mem, the flow velocity of water is 7.1-fold higher, and the residuals of sample are decreased by 60-67%, comparing those in NC Mem. SS Mem is used as lateral-flow membrane to prepare lateral-flow strips of nanogold LFA and fluorescence LFA for rapid detection of SARS CoV-2 nucleocapsid protein. These LFAs require 210 s per detection, with limits of detection of 3.98 pg mL-1 and 53.3 fg mL-1, sensitivity of 96.5%, and specificity of 90%. The results suggest that SS Mem enables ultrafast, highly sensitive lateral-flow immunoassays and shows great potential as a new type of lateral-flow membrane to broaden the application of LFA.
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Affiliation(s)
- Yiren Liu
- School of Biomedical Engineering, Shenzhen Campus of Sun Yat-sen University, Shenzhen, 518107, China
- Key Laboratory of Sensing Technology and Biomedical Instruments of Guangdong Province, School of Biomedical Engineering, Sun Yat-sen University, Guangzhou, 510275, China
| | - Juanhua Li
- School of Biomedical Engineering, Shenzhen Campus of Sun Yat-sen University, Shenzhen, 518107, China
- Key Laboratory of Sensing Technology and Biomedical Instruments of Guangdong Province, School of Biomedical Engineering, Sun Yat-sen University, Guangzhou, 510275, China
| | - Zihan Xiao
- School of Biomedical Engineering, Shenzhen Campus of Sun Yat-sen University, Shenzhen, 518107, China
| | - Tianyu Wu
- School of Biomedical Engineering, Shenzhen Campus of Sun Yat-sen University, Shenzhen, 518107, China
| | - Cuiping Zhou
- Department of Emergency, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China
| | - Jianhua Zhou
- School of Biomedical Engineering, Shenzhen Campus of Sun Yat-sen University, Shenzhen, 518107, China
- Key Laboratory of Sensing Technology and Biomedical Instruments of Guangdong Province, School of Biomedical Engineering, Sun Yat-sen University, Guangzhou, 510275, China
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13
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Manten K, Katzenschlager S, Brümmer LE, Schmitz S, Gaeddert M, Erdmann C, Grilli M, Pollock NR, Macé A, Erkosar B, Carmona S, Ongarello S, Johnson CC, Sacks JA, Faehling V, Bornemann L, Weigand MA, Denkinger CM, Yerlikaya S. Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis. Virol J 2024; 21:99. [PMID: 38685117 PMCID: PMC11059670 DOI: 10.1186/s12985-024-02371-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2024] [Accepted: 04/17/2024] [Indexed: 05/02/2024] Open
Abstract
BACKGROUND During the COVID-19 pandemic, antigen diagnostic tests were frequently used for screening, triage, and diagnosis. Novel instrument-based antigen tests (iAg tests) hold the promise of outperforming their instrument-free, visually-read counterparts. Here, we provide a systematic review and meta-analysis of the SARS-CoV-2 iAg tests' clinical accuracy. METHODS We systematically searched MEDLINE (via PubMed), Web of Science, medRxiv, and bioRxiv for articles published before November 7th, 2022, evaluating the accuracy of iAg tests for SARS-CoV-2 detection. We performed a random effects meta-analysis to estimate sensitivity and specificity and used the QUADAS-2 tool to assess study quality and risk of bias. Sub-group analysis was conducted based on Ct value range, IFU-conformity, age, symptom presence and duration, and the variant of concern. RESULTS We screened the titles and abstracts of 20,431 articles and included 114 publications that fulfilled the inclusion criteria. Additionally, we incorporated three articles sourced from the FIND website, totaling 117 studies encompassing 95,181 individuals, which evaluated the clinical accuracy of 24 commercial COVID-19 iAg tests. The studies varied in risk of bias but showed high applicability. Of 24 iAg tests from 99 studies assessed in the meta-analysis, the pooled sensitivity and specificity compared to molecular testing of a paired NP swab sample were 76.7% (95% CI 73.5 to 79.7) and 98.4% (95% CI 98.0 to 98.7), respectively. Higher sensitivity was noted in individuals with high viral load (99.6% [95% CI 96.8 to 100] at Ct-level ≤ 20) and within the first week of symptom onset (84.6% [95% CI 78.2 to 89.3]), but did not differ between tests conducted as per manufacturer's instructions and those conducted differently, or between point-of-care and lab-based testing. CONCLUSION Overall, iAg tests have a high pooled specificity but a moderate pooled sensitivity, according to our analysis. The pooled sensitivity increases with lower Ct-values (a proxy for viral load), or within the first week of symptom onset, enabling reliable identification of most COVID-19 cases and highlighting the importance of context in test selection. The study underscores the need for careful evaluation considering performance variations and operational features of iAg tests.
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Affiliation(s)
- Katharina Manten
- Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany
- Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
| | - Stephan Katzenschlager
- Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany
| | - Lukas E Brümmer
- Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
| | - Stephani Schmitz
- Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
- Department of Developmental Biology, Erasmus Medical Center, Rotterdam, Netherlands
| | - Mary Gaeddert
- Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
| | | | - Maurizio Grilli
- Library, University Medical Center Mannheim, Mannheim, Germany
| | - Nira R Pollock
- Department of Laboratory Medicine, Boston Children's Hospital, Boston, MA, USA
| | | | | | | | | | - Cheryl C Johnson
- Global HIV, Hepatitis and STIs Programmes, World Health Organization, Geneva, Switzerland
| | - Jilian A Sacks
- Department of Epidemic and Pandemic Preparedness and Prevention, World Health Organization, Geneva, Switzerland
| | - Verena Faehling
- Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
| | - Linus Bornemann
- Institute of Virology, Faculty of Medicine, University Medical Centre, University of Freiburg, Freiburg, Germany
| | - Markus A Weigand
- Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany
| | - Claudia M Denkinger
- Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
- German Center for Infection Research (DZIF), partner site Heidelberg University Hospital, Heidelberg, Germany
| | - Seda Yerlikaya
- Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany.
- German Center for Infection Research (DZIF), partner site Heidelberg University Hospital, Heidelberg, Germany.
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14
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Piubelli C, Treggiari D, Lavezzari D, Deiana M, Dishnica K, Tosato EMS, Mazzi C, Cattaneo P, Mori A, Pomari E, Nicolini L, Leonardi M, Perandin F, Formenti F, Giorgetti A, Conti A, Capobianchi MR, Gobbi FG, Castilletti C. Wide Real-Life Data Support Reduced Sensitivity of Antigen Tests for Omicron SARS-CoV-2 Infections. Viruses 2024; 16:657. [PMID: 38793539 PMCID: PMC11125898 DOI: 10.3390/v16050657] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2024] [Revised: 04/17/2024] [Accepted: 04/19/2024] [Indexed: 05/26/2024] Open
Abstract
With the continuous spread of new SARS-CoV-2 variants of concern (VOCs), the monitoring of diagnostic test performances is mandatory. We evaluated the changes in antigen diagnostic tests' (ADTs) accuracy along the Delta to Omicron VOCs transition, exploring the N protein mutations possibly affecting ADT sensitivity and assessing the best sampling site for the diagnosis of Omicron infections. In total, 5175 subjects were enrolled from 1 October 2021 to 15 July 2022. The inclusion criteria were SARS-CoV-2 ADT combined with a same-day RT-PCR swab test. For the sampling site analysis, 61 patients were prospectively recruited during the Omicron period for nasal and oral swab analyses by RT-PCR. Next-Generation Sequencing data were obtained to evaluate the different sublineages. Using RT-PCR as a reference, 387 subjects resulted in becoming infected and the overall sensitivity of the ADT decreased from 63% in the Delta period to 33% in the Omicron period. This decrease was highly statistically significant (p < 0.001), and no decrease in viral load was detected at the RNA level. The nasal site presented a significantly higher viral load than the oral site during the Omicron wave. The reduced detection rate of Omicron infections by ADT should be considered in the global testing strategy to preserve accurate diagnoses across the changing SARS-CoV-2 variants.
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Affiliation(s)
- Chiara Piubelli
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Davide Treggiari
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Denise Lavezzari
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Michela Deiana
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Klevia Dishnica
- Department of Biotechnology, University of Verona, 37124 Verona, Italy
| | | | - Cristina Mazzi
- Centre for Clinical Research, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy;
| | - Paolo Cattaneo
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Antonio Mori
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Elena Pomari
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Lavinia Nicolini
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Martina Leonardi
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Francesca Perandin
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Fabio Formenti
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | | | - Antonio Conti
- Clinical Analysis Laboratory and Transfusional Service, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy
| | - Maria Rosaria Capobianchi
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Federico Giovanni Gobbi
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
| | - Concetta Castilletti
- Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy (L.N.)
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15
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Saeed U, Uppal R, Khan AA, Uppal MR, Piracha ZZ, Uppal SR. Analytical assessment of clinical sensitivity and specificities of pharmaceutical rapid SARS-CoV-2 detection nasopharyngeal swab testing kits in Pakistan. BRAZ J BIOL 2024; 84:e265550. [PMID: 38451627 DOI: 10.1590/1519-6984.265550] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2022] [Accepted: 10/28/2022] [Indexed: 03/08/2024] Open
Abstract
Despite of the global unity against COVID-19 pandemic, the threat of SARS-CoV-2 variants on the lives of human being is still not over. SARS-CoV-2 pandemic has urged the need of rapid viral detection at earliest. To cope with gradually expanding scenario of SARS-CoV-2, accurate diagnosis is extremely crucial factor which should be noticed by international health organizations. Limited research followed by sporadic marketing of SARS-CoV-2 rapid pharmaceutical detection kits raises critical questions against quality assurance and quality control measures. Herein we aimed to interrogate effectivity and specificity analysis of SARS-CoV-2 pharmaceutical rapid detection kits (nasopharyngeal swab based) using conventional gold standard triple target real-time polymerase chain reaction (USFDA approved). A cross-sectional study was conducted over 1500 suspected SARS-CoV-2 patients. 100 real time-PCR confirmed patients were evaluated for pharmaceutical RDT kits based upon nasopharyngeal swab based kits. The SARS-CoV-2 nasopharyngeal swab based rapid diagnostic kit (NSP RDTs) analysis showed 78% reactivity. Among real time PCR confirmed negative subjects, 49.3% represented false positivity. The positive predictive analysis revealed 67.82%, while negative predictive values were 64.40%. The NSP RDTs showed limited sensitivities and specificities as compared to gold standard real time PCR. Valid and authentic detection of SARS-CoV-2 is deemed necessary for accurate COVID-19 surveillance across the globe. Current study highlights the potential consequences of inadequate detection of SARS-CoV-2 and emerging novel mutants, compromising vaccine preventable diseases. Current study emphasizes need to wake higher authorities including strategic organizations for designing adequate measures to prevent future SARS-CoV-2 epidemics.
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Affiliation(s)
- U Saeed
- Islamabad Diagnostic Center - IDC, Department of Research and Development, Islamabad, Pakistan
- Foundation University Islamabad Pakistan, Foundation University School of Health Sciences, Clinical and Biomedical Research Center, Islamabad, Pakistan
| | - R Uppal
- Islamabad Diagnostic Center - IDC, Department of Research and Development, Islamabad, Pakistan
| | - A A Khan
- Islamabad Diagnostic Center - IDC, Department of Research and Development, Islamabad, Pakistan
| | - M R Uppal
- Islamabad Diagnostic Center - IDC, Department of Research and Development, Islamabad, Pakistan
| | - Z Z Piracha
- International Center of Medical Sciences Research - ICMSR, Islamabad, Pakistan
- International Center of Medical Sciences Research - ICMSR, Austin, TX, United States of America
- International Center of Medical Sciences Research - ICMSR, Chadwell Health, United Kingdom
| | - S R Uppal
- Islamabad Diagnostic Center - IDC, Department of Research and Development, Islamabad, Pakistan
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16
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Haun BK, To A, Williams CA, Ball A, Fong K, Wong TAS, Shobayo B, Teahton J, Ching L, Kamara V, Tekah DM, Humphrey P, Berestecky J, Nerurkar VR, Lehrer AT. A Serological Multiplexed Immunoassay (MIA) Detects Antibody Reactivity to SARS-CoV-2 and Other Viral Pathogens in Liberia and Is Configurable as a Multiplexed Inhibition Test (MINT). IMMUNO 2024; 4:108-124. [PMID: 39391865 PMCID: PMC11465787 DOI: 10.3390/immuno4010007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/12/2024] Open
Abstract
The SARS-CoV-2 pandemic ignited global efforts to rapidly develop testing, therapeutics, and vaccines. However, the rewards of these efforts were slow to reach many low- to middle-income countries (LMIC) across the African continent and globally. Therefore, two bead-based multiplexed serological assays were developed to determine SARS-CoV-2 exposure across four counties in Liberia. This study was conducted during the summer of 2021 on 189 samples collected throughout Grand Bassa, Bong, Margibi, and Montserrado counties. Our multiplexed immunoassay (MIA) detected elevated exposure to SARS-CoV-2 and multiple variant antigens. Additionally, we detected evidence of exposure to Dengue virus serotype 2, Chikungunya virus, and the seasonal coronavirus NL63. Our multiplexed inhibition test (MINT) was developed from the MIA to observe antibody-mediated inhibition of SARS-CoV-2 spike protein binding to its cognate cellular receptor ACE-2. We detected inhibitory antibodies in the tested Liberian samples, which were collectively consistent with a convalescent serological profile. These complementary assays serve to supplement existing serological testing needs and may enhance the technical capacity of scientifically underrepresented regions globally.
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Affiliation(s)
- Brien K. Haun
- Department of Cell and Molecular Biology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
| | - Albert To
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
| | - Caitlin A. Williams
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
| | - Aquena Ball
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
| | - Karalyn Fong
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
| | - Teri Ann S. Wong
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
| | - Bode Shobayo
- National Public Health Institute of Liberia, Monrovia 1000, Liberia
| | - Julius Teahton
- National Public Health Institute of Liberia, Monrovia 1000, Liberia
| | - Lauren Ching
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
| | - Varney Kamara
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
- Department of Biological Sciences, Medical Science, TJR Faulkner College of Science and Technology, University of Liberia, Fendall 1000, Liberia
| | - Davidetta M. Tekah
- Department of Biological Sciences, Medical Science, TJR Faulkner College of Science and Technology, University of Liberia, Fendall 1000, Liberia
| | - Peter Humphrey
- Department of Biological Sciences, Medical Science, TJR Faulkner College of Science and Technology, University of Liberia, Fendall 1000, Liberia
| | - John Berestecky
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
- Department of Biological Sciences, Medical Science, TJR Faulkner College of Science and Technology, University of Liberia, Fendall 1000, Liberia
- Math Science Department, Kapiolani Community College, University of Hawaii, Honolulu, HI 96816, USA
| | - Vivek R. Nerurkar
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
| | - Axel T. Lehrer
- Department of Cell and Molecular Biology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
- Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI 96813, USA
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El-Daly MM. Advances and Challenges in SARS-CoV-2 Detection: A Review of Molecular and Serological Technologies. Diagnostics (Basel) 2024; 14:519. [PMID: 38472991 DOI: 10.3390/diagnostics14050519] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2024] [Revised: 02/20/2024] [Accepted: 02/24/2024] [Indexed: 03/14/2024] Open
Abstract
The urgent need for accurate COVID-19 diagnostics has led to the development of various SARS-CoV-2 detection technologies. Real-time reverse transcriptase polymerase chain reaction (RT-qPCR) remains a reliable viral gene detection technique, while other molecular methods, including nucleic acid amplification techniques (NAATs) and isothermal amplification techniques, provide diverse and effective approaches. Serological assays, detecting antibodies in response to viral infection, are crucial for disease surveillance. Saliva-based immunoassays show promise for surveillance purposes. The efficiency of SARS-CoV-2 antibody detection varies, with IgM indicating recent exposure and IgG offering prolonged detectability. Various rapid tests, including lateral-flow immunoassays, present opportunities for quick diagnosis, but their clinical significance requires validation through further studies. Challenges include variations in specificity and sensitivity among testing platforms and evolving assay sensitivities over time. SARS-CoV-2 antigens, particularly the N and S proteins, play a crucial role in diagnostic methods. Innovative approaches, such as nanozyme-based assays and specific nucleotide aptamers, offer enhanced sensitivity and flexibility. In conclusion, ongoing advancements in SARS-CoV-2 detection methods contribute to the global effort in combating the COVID-19 pandemic.
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Affiliation(s)
- Mai M El-Daly
- Special Infectious Agents Unit-BSL3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah 21589, Saudi Arabia
- Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah 21589, Saudi Arabia
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18
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Gobena D, Gudina EK, Gebre G, Degfie TT, Mekonnen Z. Rapid antigen test as a screening tool for SARS-CoV-2 infection: Head-to-head comparison with qRT-PCR in Ethiopia. Heliyon 2024; 10:e23518. [PMID: 38169801 PMCID: PMC10758869 DOI: 10.1016/j.heliyon.2023.e23518] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/07/2023] [Revised: 12/05/2023] [Accepted: 12/05/2023] [Indexed: 01/05/2024] Open
Abstract
Objective This study aimed to determine the diagnostic accuracy of the antigen rapid diagnostic test (Ag-RDT) as a screening tool for SARS-CoV-2 infection compared to Quantitative reverse transcription polymerase chain reaction (qRT-PCR). Methods This study was conducted at six referral hospitals in Oromia Region, Ethiopia. One thousand seven hundred twenty-one patients who visited the hospitals for various medical conditions were tested with qRT-PCR and/or Ag-RDTs. Qualitative detection of SARS-CoV-2 antigen was performed using the Panbio™ COVID-19 Ag rapid test device. Results Compared with qRT-PCR, Ag-RDTs had a sensitivity of 33.3 % (95%CI: 30.9%-35.9 %) and a specificity of 99.3 % (95%CI: 98.8%-99.7 %) to detect active SARS-CoV-2 infection. The area under the receiver operator curve was 0.67 (95%CI: 0.63-0.69). The sensitivity of Ag-RDTs appeared high in patients with shortness of breath (73.3 %) and those presenting with all three symptoms - fever, cough, and dyspnea (71.4 %). In all instances, specificity was more than 98 %. The Ag-RDT positivity rate also correlated well with viral load: 51.7 % in cases with cycle threshold (Ct) < 25 (high viral load) and only 3.4 % when Ct > 25 (low viral load). Conclusion Although Ag-RDT for diagnosing SARS-CoV-2 is a good option as a point-of-care screening tool, it has a low sensitivity to detect active infections. Using Panbio™ COVID-19 Ag Rapid test for diagnostic and treatment decisions may lead to a false negative, resulting in patient misdiagnosis, ultimately contributing to disease spread and poor patient outcome.
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Affiliation(s)
- Dabesa Gobena
- Public Health Emergency Management and Health Research Directorate, Oromia Health Bureau, Addis Ababa, Ethiopia
- School of Medical Laboratory Sciences, Institute of Health, Jimma University, Jimma, Ethiopia
| | | | - Getu Gebre
- Public Health Emergency Management and Health Research Directorate, Oromia Health Bureau, Addis Ababa, Ethiopia
| | - Tizta Tilahun Degfie
- Department of Reproductive Health and Population Studies, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia
- Fenot Project, Department of Global Health and Population, Harvard T.H. Chan School, Ethiopia
| | - Zeleke Mekonnen
- School of Medical Laboratory Sciences, Institute of Health, Jimma University, Jimma, Ethiopia
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19
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Queiroz BL, do Nascimento CQ, de Souza TOM, Bádue GS, Bueno NB, Vasconcelos SML, Mello CS, Ribeiro-Andrade M, Ataíde TDR, Barros-Neto JA. Effects of SARS-CoV-2 infection on health and functional capacity in institutionalized older adults. Rev Esc Enferm USP 2023; 57:e20230128. [PMID: 38131441 PMCID: PMC10744536 DOI: 10.1590/1980-220x-reeusp-2023-0128en] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/23/2023] [Accepted: 10/18/2023] [Indexed: 12/23/2023] Open
Abstract
OBJECTIVE To assess the effect of SARS-CoV-2 infection on the health conditions and functional capacity of older adults living in long-term care units in Maceió City - Alagoas State. METHODS A prospective cohort was conducted with institutionalized older adults of both sexes. Older adults were assessed for clinical conditions (diagnosis of chronic diseases and biochemical tests), functional capacity, and nutritional status. All assessments were repeated on two occasions, maintaining a 6-month interval between them. RESULTS The sample was composed of 289 older adults. Of the total, 98 (33.9%) were positive for COVID-19 and eight died (2.8%). Men were more likely to have COVID-19 (OR = 3.50; p < 0.01). It was observed that the disease contributed to increasing the frequency of dependent older adults after six months (OR = 1.38; p-interaction < 0.01). It was also observed that after six months of positive diagnosis for COVID-19, there was greater weight loss (p < 0.01), reduced BMI (p < 0.01), increased mean SBP (p = 0.04), and DBP (p = 0.03). CONCLUSION Effects of COVID-19 in institutionalized older adults go beyond acute complications and compromise blood pressure control, functional capacity, and favor weight loss.
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Affiliation(s)
| | | | | | | | | | | | | | - Müller Ribeiro-Andrade
- Universidade Federal de Alagoas, Instituto de Ciências Biológicas e da Saúde, Maceió, AL, Brazil
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20
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Gupta R, Gupta P, Wang S, Melnykov A, Jiang Q, Seth A, Wang Z, Morrissey JJ, George I, Gandra S, Sinha P, Storch GA, Parikh BA, Genin GM, Singamaneni S. Ultrasensitive lateral-flow assays via plasmonically active antibody-conjugated fluorescent nanoparticles. Nat Biomed Eng 2023; 7:1556-1570. [PMID: 36732621 DOI: 10.1038/s41551-022-01001-1] [Citation(s) in RCA: 55] [Impact Index Per Article: 27.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2022] [Accepted: 12/20/2022] [Indexed: 02/04/2023]
Abstract
Lateral-flow assays (LFAs) are rapid and inexpensive, yet they are nearly 1,000-fold less sensitive than laboratory-based tests. Here we show that plasmonically active antibody-conjugated fluorescent gold nanorods can make conventional LFAs ultrasensitive. With sample-to-answer times within 20 min, plasmonically enhanced LFAs read out via a standard benchtop fluorescence scanner attained about 30-fold improvements in dynamic range and in detection limits over 4-h-long gold-standard enzyme-linked immunosorbent assays, and achieved 95% clinical sensitivity and 100% specificity for antibodies in plasma and for antigens in nasopharyngeal swabs from individuals with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Comparable improvements in the assay's performance can also be achieved via an inexpensive portable scanner, as we show for the detection of interleukin-6 in human serum samples and of the nucleocapsid protein of SARS-CoV-2 in nasopharyngeal samples. Plasmonically enhanced LFAs outperform standard laboratory tests in sensitivity, speed, dynamic range, ease of use and cost, and may provide advantages in point-of-care diagnostics.
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Affiliation(s)
- Rohit Gupta
- Department of Mechanical Engineering and Materials Science, Institute of Materials Science and Engineering, Washington University in St. Louis, St. Louis, MO, USA
| | - Prashant Gupta
- Department of Mechanical Engineering and Materials Science, Institute of Materials Science and Engineering, Washington University in St. Louis, St. Louis, MO, USA
| | - Sean Wang
- Department of Biology, Washington University in St. Louis, St. Louis, MO, USA
| | | | | | - Anushree Seth
- Department of Mechanical Engineering and Materials Science, Institute of Materials Science and Engineering, Washington University in St. Louis, St. Louis, MO, USA
| | - Zheyu Wang
- Department of Mechanical Engineering and Materials Science, Institute of Materials Science and Engineering, Washington University in St. Louis, St. Louis, MO, USA
| | - Jeremiah J Morrissey
- Department of Anesthesiology, Division of Clinical and Translational Research, Washington University in St. Louis, St. Louis, MO, USA
- Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA
| | - Ige George
- Department of Internal Medicine, Division of Infectious Diseases, Washington University School of Medicine, St. Louis, MO, USA
| | - Sumanth Gandra
- Department of Internal Medicine, Division of Infectious Diseases, Washington University School of Medicine, St. Louis, MO, USA
| | - Pratik Sinha
- Department of Anesthesiology, Division of Clinical and Translational Research, Washington University in St. Louis, St. Louis, MO, USA
| | - Gregory A Storch
- Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, USA
| | - Bijal A Parikh
- Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA
| | - Guy M Genin
- Department of Mechanical Engineering and Materials Science, Institute of Materials Science and Engineering, Washington University in St. Louis, St. Louis, MO, USA
- NSF Science and Technology Center for Engineering MechanoBiology, Washington University in St. Louis, St. Louis, MO, USA
| | - Srikanth Singamaneni
- Department of Mechanical Engineering and Materials Science, Institute of Materials Science and Engineering, Washington University in St. Louis, St. Louis, MO, USA.
- Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
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21
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Seck MC, Badiane AS, Thwing J, Ndiaye M, Diongue K, Ndiaye IM, Diallo MA, Sy M, Gomis JF, Ndiaye T, Gaye A, Lee YM, Secor WE, Ndiaye D, Rogier E. SEROPREVALENCE TO SCHISTOSOMA SOLUBLE EGG ANTIGEN AMONG NOMADIC PASTORALISTS RESIDING IN NORTHERN SENEGAL. J Parasitol 2023; 109:580-587. [PMID: 38104629 DOI: 10.1645/22-69] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2023] Open
Abstract
Urinary and intestinal schistosomiasis are endemic in Senegal, with prevalence heterogeneous throughout the country. Because of their way of life, nomadic pastoralists are not typically included in epidemiological surveys, and data on the prevalence of schistosomiasis in Senegalese nomadic populations are largely non-existent. The purpose of this study was to determine the seroprevalence of schistosomiasis in Senegalese nomadic pastoralists. A modified snowball sampling survey was conducted among 1,467 nomadic pastoralists aged 6 mo and older in 5 districts in northern Senegal. Dried blood spots from participants of all ages and data regarding demographics were collected to assess IgG antibody responses against Schistosoma mansoni soluble egg antigen (SEA) using a bead-based multiplex assay. Out of 1,467 study subjects, 1,464 (99.8%) provided IgG serological data that cleared quality assurance. Of the participants with appropriate data, 56.6% were male, the median age was 22 yr, and 31.6% were under 15 yr of age. The overall anti-SEA IgG seroprevalence was 19.1% (95% confidence interval [CI]: 17.1-21.1%) with the highest estimates observed in Dagana (35.9%) and the lowest observed in Podor nomadic groups (3.4%). Antibody responses increased significantly with age except for the oldest age groups (>40 yr of age), which saw lower levels of antibody response compared to younger adults. When controlling for age and location by multivariate regression, the male sex was associated with a 2-fold greater odds of anti-SEA IgG seropositivity (aPOR: 2.0; 95% CI: 1.5-2.7). Serosurveys for anti-SEA IgG among nomadic peoples in northern Senegal found a substantial percentage of individuals with evidence for current or previous Schistosoma spp. infection with the highest levels of exposure in the district adjacent to the Diama dam along the Senegal River. With IgG prevalence increased by age except in the older adults, and the male sex significantly associated with seropositivity, these data point toward sex-associated behavioral practices and human environmental modification as risk factors for Schistosoma exposure.
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Affiliation(s)
- Mame Cheikh Seck
- Department of Parasitology, Faculty of Medicine and Pharmacy, Cheikh Anta Diop University, Dakar 16477, Senegal
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Aida Sadikh Badiane
- Department of Parasitology, Faculty of Medicine and Pharmacy, Cheikh Anta Diop University, Dakar 16477, Senegal
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Julie Thwing
- Division of Parasitic Diseases and Malaria, U.S. Centers for Disease Control and Prevention, Atlanta, Georgia 30329
| | - Mouhamadou Ndiaye
- Department of Parasitology, Faculty of Medicine and Pharmacy, Cheikh Anta Diop University, Dakar 16477, Senegal
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Khadim Diongue
- Department of Parasitology, Faculty of Medicine and Pharmacy, Cheikh Anta Diop University, Dakar 16477, Senegal
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Ibrahima Mbaye Ndiaye
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Mamadou Alpha Diallo
- Department of Parasitology, Faculty of Medicine and Pharmacy, Cheikh Anta Diop University, Dakar 16477, Senegal
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Mohamed Sy
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Jules François Gomis
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Tolla Ndiaye
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Aminata Gaye
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Yeuk-Mui Lee
- Division of Parasitic Diseases and Malaria, U.S. Centers for Disease Control and Prevention, Atlanta, Georgia 30329
| | - W Evan Secor
- Division of Parasitic Diseases and Malaria, U.S. Centers for Disease Control and Prevention, Atlanta, Georgia 30329
| | - Daouda Ndiaye
- Department of Parasitology, Faculty of Medicine and Pharmacy, Cheikh Anta Diop University, Dakar 16477, Senegal
- International Research & Training Center in Applied Genomics and Health Surveillance (CIGASS), Cheikh Anta Diop University, Dakar 16477, Senegal
| | - Eric Rogier
- Current address: Division of Digestive Disease and Nutrition, University of Kentucky, Lexington, Kentucky 40506
- At the time of this work was employed by the U.S. Centers for Disease Control and Prevention, Atlanta, Georgia 30329
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22
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Moreno-Contreras J, Espinoza MA, Cantú-Cuevas MA, Madrid-González DA, Barón-Olivares H, Ortiz-Orozco OD, Guzmán-Rodríguez C, Arias CF, Lopez S. Saliva sampling and its direct lysis is an excellent option for SARS-CoV-2 diagnosis in paediatric patients: comparison with the PanBio COVID-19 antigen rapid test in symptomatic and asymptomatic children. J Med Microbiol 2023; 72. [PMID: 38014762 DOI: 10.1099/jmm.0.001779] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2023] Open
Abstract
Introduction. Lateral flow test (LFTs) have been used as an alternative to reverse transcription quantitative PCR (RT-qPCR) in point-of-care testing. Despite their benefits, the sensitivity of LFTs may be low and is affected by several factors. We have previously reported the feasibility of using direct lysis of individual or pools of saliva samples from symptomatic and asymptomatic patients as a source of viral genomes for detection by RT-qPCR.Hypothesis. Direct lysed saliva is more sensitive than antigen tests to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in samples from children.Aim. Our goals here were to valuate the specificity and sensitivity of the PanBio COVID-19 antigen rapid test device (Ag-RTD) compared with RT-qPCR of direct lysed saliva.Methodology. We evaluated the performance of the PanBio COVID-19 Ag-RTD in comparison to RT-qPCR direct lysed saliva from paired samples of 256 symptomatic and 242 asymptomatic paediatric patients.Results. Overall, although there were no differences in the specificity (96.6%), we found a lower sensitivity (64.3%) of the PanBio Ag-test RTD compared to saliva in both symptomatic and asymptomatic patients. In addition, the sensitivity of PanBio was not correlated with the viral load present in the samples.Conclusion. Our data highlight the benefits of using RT-qPCR and saliva samples for SARS-CoV-2 detection, particularly in paediatric patients.
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Affiliation(s)
- Joaquín Moreno-Contreras
- Departamento de Genética del Desarrollo y Fisiología Molecular, Instituto de Biotecnología UNAM, Av. Universidad 2001, Col. Chamilpa, Cuernavaca, Morelos, Mexico
| | - Marco A Espinoza
- Departamento de Genética del Desarrollo y Fisiología Molecular, Instituto de Biotecnología UNAM, Av. Universidad 2001, Col. Chamilpa, Cuernavaca, Morelos, Mexico
| | - Marco A Cantú-Cuevas
- Secretaría de Salud del Edo. de Morelos, Ajusco #2 Col. Buena Vista, Cuernavaca, Morelos, Mexico
| | - Daniel A Madrid-González
- Secretaría de Salud del Edo. de Morelos, Ajusco #2 Col. Buena Vista, Cuernavaca, Morelos, Mexico
| | - Héctor Barón-Olivares
- Servicios de Salud del Edo. de Morelos, Callejón Borda 3 Col. Centro, Cuernavaca, Morelos, Mexico
| | - Oscar D Ortiz-Orozco
- Servicios de Salud del Edo. de Morelos, Callejón Borda 3 Col. Centro, Cuernavaca, Morelos, Mexico
| | - Cecilia Guzmán-Rodríguez
- Servicios de Salud del Edo. de Morelos, Callejón Borda 3 Col. Centro, Cuernavaca, Morelos, Mexico
| | - Carlos F Arias
- Departamento de Genética del Desarrollo y Fisiología Molecular, Instituto de Biotecnología UNAM, Av. Universidad 2001, Col. Chamilpa, Cuernavaca, Morelos, Mexico
| | - Susana Lopez
- Departamento de Genética del Desarrollo y Fisiología Molecular, Instituto de Biotecnología UNAM, Av. Universidad 2001, Col. Chamilpa, Cuernavaca, Morelos, Mexico
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23
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Shen XX, Li FY, Qin M, Zhang GH, Zhang MY, Liu H, Sun XL, Xin ZJ, Ma XJ. Multicenter evaluation of a simple and sensitive nucleic acid self-testing for SARS-CoV-2. Virol Sin 2023; 38:620-626. [PMID: 37406815 PMCID: PMC10436039 DOI: 10.1016/j.virs.2023.06.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/04/2023] [Accepted: 06/29/2023] [Indexed: 07/07/2023] Open
Abstract
A rapid and accurate COVID-19 diagnosis is a prerequisite for blocking the source of infection as soon as possible and taking the appropriate medical action. Herein, we developed GeneClick, a device for nucleic acid self-testing of SARS-CoV-2, consisting of three modules: a sampling kit, a microfluidic chip-based disposable cartridge, and an amplification reader. In addition, we evaluated the clinical performance of GeneClick using 2162 nasal swabs collected at three medical institutions, using three commercial RT-qPCR kits and an antigen self-test as references. Compared to RT-qPCR, the sensitivity and specificity of the GeneClick assay were 97.93% and 99.72%, respectively, with a kappa value of 0.979 (P < 0.01). Of the 2162 samples, 2076 were also tested for SARS-CoV-2 antigens. Among the 314 positive samples identified by GeneClick assay, 63 samples were undetected by antigen tests. Overall, the GeneClick nucleic acid self-test demonstrated higher accuracy than the antigen-based detection. Based on the additional features, including simple operation, affordable price, portable device, and reliability of smartphone APP-driven sampling and result reporting, GeneClick offers a powerful tool for field-based SARS-CoV-2 detection in primary healthcare institutions or at-home use.
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Affiliation(s)
- Xin-Xin Shen
- NHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, China
| | - Feng-Yu Li
- NHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, China; Hebei Medical University, Shijiazhuang, 050031, China
| | - Meng Qin
- Fengtai District Center for Disease Control and Prevention of Beijing, Beijing, 100071, China
| | - Guo-Hao Zhang
- Beijing Baicare Biotechnology Co., Ltd., Beijing, 102206, China
| | - Meng-Yi Zhang
- NHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, China
| | - Hong Liu
- Shandong University of Technology, School of Life Sciences and Medicine, Zibo, 255000, China
| | - Xiu-Li Sun
- NHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, China
| | - Zhen-Jiang Xin
- Fengtai District Center for Disease Control and Prevention of Beijing, Beijing, 100071, China.
| | - Xue-Jun Ma
- NHC Key Laboratory of Medical Virology and Viral Diseases, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, China.
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24
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Do KH, Yang J, Do OS, Yoo SJ. Epidemiological analysis of coronavirus disease (COVID-19) patients on ships arriving at Busan port in Korea, 2020. PLoS One 2023; 18:e0288064. [PMID: 37450548 PMCID: PMC10348537 DOI: 10.1371/journal.pone.0288064] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2023] [Accepted: 06/17/2023] [Indexed: 07/18/2023] Open
Abstract
Quarantine played an important role in preventing the spread of infectious diseases between countries in the early stages of the COVID-19 outbreak. In particular, in ports, infection during transit can cause a large number of patients on board ships and can flow into the community. In this study investigated cause of the cause of transmission in ships and suggested the way of preventing secondary transmission by analyzing clinical and epidemiological characteristics of COVID-19 patients identified at Busan Port (South Korea) in 2020. During the study period, out of 19,396 ships that arrived at Busan Port, 50 ships had COVID-19 confirmed cases. Among the 50 ships, type of deep-sea fishing vessels (24 ships, 48.0%), ships weighing less than 5,000 tons (31 ships, 62.0%), and ships from Russia (41 ships, 82.0%) had the highest positivity rates. Total 283 of the 25,450 arrivals tested positive for COVID-19 (a positivity rate of 1.1%), and 270 (95.4%) were asymptomatic. Moreover, the number of COVID-19 patients increased with the duration of the waiting period between arrival and sample collection (12.7% to 37.4%), and the positivity rate was significantly higher for those working as stewards (64.3%). These results indicate secondary transmission was active on board ships and that infection among stewards importantly contributed to group outbreaks. In addition, onboard residence time after arrival significantly elevated to COVID-19 positivity rates, indicating that rapid isolation, as determined using various screening techniques, might be effective at preventing onboard transmission and subsequent community outbreaks.
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Affiliation(s)
- Kee Hun Do
- Gimhae Airport National Quarantine Station, Gyeongnam Regional Disease Response Center, Korea Disease Control and Prevention Agency, Busan, Korea
| | - Jinseon Yang
- Busan National Quarantine Station, Gyeongnam Regional Disease Response Center, Korea Disease Control and Prevention Agency, Busan, Korea
| | - Ok Sook Do
- Busan National Quarantine Station, Gyeongnam Regional Disease Response Center, Korea Disease Control and Prevention Agency, Busan, Korea
| | - Seok-Ju Yoo
- Department of Preventive Medicine, Dongguk University College of Medicine, Gyeongju, Korea
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25
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Davoodi M, Batista A, Senapati A, Calabrese JM. Personnel Scheduling during the COVID-19 Pandemic: A Probabilistic Graph-Based Approach. Healthcare (Basel) 2023; 11:1917. [PMID: 37444751 DOI: 10.3390/healthcare11131917] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/29/2023] [Revised: 06/27/2023] [Accepted: 06/28/2023] [Indexed: 07/15/2023] Open
Abstract
Effective personnel scheduling is crucial for organizations to match workload demands. However, staff scheduling is sometimes affected by unexpected events, such as the COVID-19 pandemic, that disrupt regular operations. Limiting the number of on-site staff in the workplace together with regular testing is an effective strategy to minimize the spread of infectious diseases like COVID-19 because they spread mostly through close contact with people. Therefore, choosing the best scheduling and testing plan that satisfies the goals of the organization and prevents the virus's spread is essential during disease outbreaks. In this paper, we formulate these challenges in the framework of two Mixed Integer Non-linear Programming (MINLP) models. The first model aims to derive optimal staff occupancy and testing strategies to minimize the risk of infection among employees, while the second is aimed only at optimal staff occupancy under a random testing strategy. To solve the problems expressed in the models, we propose a canonical genetic algorithm as well as two commercial solvers. Using both real and synthetic contact networks of employees, our results show that following the recommended occupancy and testing strategy reduces the risk of infection 25-60% under different scenarios. The minimum risk of infection can be achieved when the employees follow a planned testing strategy. Further, vaccination status and interaction rate of employees are important factors in developing scheduling strategies that minimize the risk of infection.
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Affiliation(s)
- Mansoor Davoodi
- Center for Advanced Systems Understanding (CASUS), Helmholtz-Zentrum Dresden Rossendorf (HZDR), 01328 Görlitz, Germany
| | - Ana Batista
- Center for Advanced Systems Understanding (CASUS), Helmholtz-Zentrum Dresden Rossendorf (HZDR), 01328 Görlitz, Germany
| | - Abhishek Senapati
- Center for Advanced Systems Understanding (CASUS), Helmholtz-Zentrum Dresden Rossendorf (HZDR), 01328 Görlitz, Germany
| | - Justin M Calabrese
- Center for Advanced Systems Understanding (CASUS), Helmholtz-Zentrum Dresden Rossendorf (HZDR), 01328 Görlitz, Germany
- Department of Ecological Modelling, Helmholtz Centre for Environmental Research (UFZ), 04318 Leipzig, Germany
- Department of Biology, University of Maryland, College Park, MD 20742, USA
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26
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Srinivas K, Gagana Sri R, Pravallika K, Nishitha K, Polamuri SR. COVID-19 prediction based on hybrid Inception V3 with VGG16 using chest X-ray images. MULTIMEDIA TOOLS AND APPLICATIONS 2023:1-18. [PMID: 37362699 PMCID: PMC10240113 DOI: 10.1007/s11042-023-15903-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 06/01/2022] [Revised: 05/12/2023] [Accepted: 05/18/2023] [Indexed: 06/28/2023]
Abstract
The Corona Virus was first started in the Wuhan city, China in December of 2019. It belongs to the Coronaviridae family, which can infect both animals and humans. The diagnosis of coronavirus disease-2019 (COVID-19) is typically detected by Serology, Genetic Real-Time reverse transcription-Polymerase Chain Reaction (RT-PCR), and Antigen testing. These testing methods have limitations like limited sensitivity, high cost, and long turn-around time. It is necessary to develop an automatic detection system for COVID-19 prediction. Chest X-ray is a lower-cost process in comparison to chest Computed tomography (CT). Deep learning is the best fruitful technique of machine learning, which provides useful investigation for learning and screening a large amount of chest X-ray images with COVID-19 and normal. There are many deep learning methods for prediction, but these methods have a few limitations like overfitting, misclassification, and false predictions for poor-quality chest X-rays. In order to overcome these limitations, the novel hybrid model called "Inception V3 with VGG16 (Visual Geometry Group)" is proposed for the prediction of COVID-19 using chest X-rays. It is a combination of two deep learning models, Inception V3 and VGG16 (IV3-VGG). To build the hybrid model, collected 243 images from the COVID-19 Radiography Database. Out of 243 X-rays, 121 are COVID-19 positive and 122 are normal images. The hybrid model is divided into two modules namely pre-processing and the IV3-VGG. In the dataset, some of the images with different sizes and different color intensities are identified and pre-processed. The second module i.e., IV3-VGG consists of four blocks. The first block is considered for VGG-16 and blocks 2 and 3 are considered for Inception V3 networks and final block 4 consists of four layers namely Avg pooling, dropout, fully connected, and Softmax layers. The experimental results show that the IV3-VGG model achieves the highest accuracy of 98% compared to the existing five prominent deep learning models such as Inception V3, VGG16, ResNet50, DenseNet121, and MobileNet.
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Affiliation(s)
- K. Srinivas
- Department of CSE, VR Siddhartha Engineering College, Vijayawada, 520007 India
| | - R. Gagana Sri
- Department of CSE, VR Siddhartha Engineering College, Vijayawada, 520007 India
| | - K. Pravallika
- Department of CSE, Sir C. R. Reddy Engineering College, Eluru, 534007 India
| | - K. Nishitha
- Department of CSE, VR Siddhartha Engineering College, Vijayawada, 520007 India
| | - Subba Rao Polamuri
- Department of CSE, Bonam Venkata Chalamayya Engineering College (Autonomous), Odalarevu, 533210 India
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Sakai-Tagawa Y, Yamayoshi S, Halfmann PJ, Wilson N, Bobholz M, Vuyk WC, Wei W, Ries H, O'Connor DH, Friedrich TC, Sordillo EM, van Bakel H, Simon V, Kawaoka Y. Sensitivity of rapid antigen tests for Omicron subvariants of SARS-CoV-2. J Med Virol 2023; 95:e28788. [PMID: 37212288 DOI: 10.1002/jmv.28788] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2023] [Revised: 04/22/2023] [Accepted: 05/02/2023] [Indexed: 05/23/2023]
Abstract
Diagnosis by rapid antigen tests (RATs) is useful for early initiation of antiviral treatment. Because RATs are easy to use, they can be adapted for self-testing. Several kinds of RATs approved for such use by the Japanese regulatory authority are available from drug stores and websites. Most RATs for COVID-19 are based on antibody detection of the SARS-CoV-2 N protein. Since Omicron and its subvariants have accumulated several amino acid substitutions in the N protein, such amino acid changes might affect the sensitivity of RATs. Here, we investigated the sensitivity of seven RATs available in Japan, six of which are approved for public use and one of which is approved for clinical use, for the detection of BA.5, BA.2.75, BF.7, XBB.1, and BQ.1.1, as well as the delta variant (B.1.627.2). All tested RATs detected the delta variant with a detection level between 7500 and 75 000 pfu per test, and all tested RATs showed similar sensitivity to the Omicron variant and its subvariants (BA.5, BA.2.75, BF.7, XBB.1, and BQ.1.1). Human saliva did not reduce the sensitivity of the RATs tested. Espline SARS-CoV-2 N showed the highest sensitivity followed by Inspecter KOWA SARS-CoV-2 and V Trust SARS-CoV-2 Ag. Since the RATs failed to detect low levels of infectious virus, individuals whose specimens contained less infectious virus than the detection limit would be considered negative. Therefore, it is important to note that RATs may miss individuals shedding low levels of infectious virus.
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Affiliation(s)
- Yuko Sakai-Tagawa
- Division of Virology, Institute of Medical Science, University of Tokyo, Tokyo, Japan
- International Research Center for Infectious Diseases, Institute of Medical Science, University of Tokyo, Tokyo, Japan
| | - Seiya Yamayoshi
- Division of Virology, Institute of Medical Science, University of Tokyo, Tokyo, Japan
- International Research Center for Infectious Diseases, Institute of Medical Science, University of Tokyo, Tokyo, Japan
- The Research Center for Global Viral Diseases, National Center for Global Health and Medicine Research Institute, Tokyo, Japan
| | - Peter J Halfmann
- Department of Pathobiological Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, Madison, Wisconsin, USA
| | - Nancy Wilson
- Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison, Wisconsin, USA
| | - Max Bobholz
- Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison, Wisconsin, USA
| | - William C Vuyk
- Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison, Wisconsin, USA
| | - Wanting Wei
- Department of Pathobiological Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, Madison, Wisconsin, USA
| | - Hunter Ries
- Department of Pathobiological Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, Madison, Wisconsin, USA
| | - David H O'Connor
- Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison, Wisconsin, USA
- Wisconsin National Primate Research Center, University of Wisconsin, Madison, Wisconsin, USA
| | - Thomas C Friedrich
- Department of Pathobiological Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, Madison, Wisconsin, USA
- Wisconsin National Primate Research Center, University of Wisconsin, Madison, Wisconsin, USA
| | - Emilia M Sordillo
- Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Harm van Bakel
- Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Icahn Genomics Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Viviana Simon
- Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Center for Vaccine Research and Pandemic Preparedness (C-VaRPP), Icahn School of Medicine at Mount Sinai, New York, New York, USA
- The Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Yoshihiro Kawaoka
- Division of Virology, Institute of Medical Science, University of Tokyo, Tokyo, Japan
- The Research Center for Global Viral Diseases, National Center for Global Health and Medicine Research Institute, Tokyo, Japan
- Department of Pathobiological Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, Madison, Wisconsin, USA
- Infection and Advanced Research Center, The University of Tokyo Pandemic Preparedness, Tokyo, Japan
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Fragkou PC, De Angelis G, Menchinelli G, Can F, Garcia F, Morfin-Sherpa F, Dimopoulou D, Dimopoulou K, Zelli S, de Salazar A, Reiter R, Janocha H, Grossi A, Omony J, Skevaki C. Update of ESCMID COVID-19 guidelines: diagnostic testing for SARS-CoV-2. Clin Microbiol Infect 2023:S1198-743X(23)00192-1. [PMID: 37088423 PMCID: PMC10122552 DOI: 10.1016/j.cmi.2023.04.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2023] [Revised: 04/13/2023] [Accepted: 04/16/2023] [Indexed: 04/25/2023]
Abstract
SCOPE Since the onset of coronavirus disease 2019 (COVID-19), several assays have been deployed for the diagnosis of SARS-CoV-2. The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) published the first set of guidelines on SARS-CoV-2 in-vitro diagnosis in February 2022. Since the COVID-19 landscape is rapidly evolving, the relevant ESCMID guidelines panel releases an update of the previously published recommendations on diagnostic testing for SARS-CoV-2. This update aims to delineate the best diagnostic approach for SARS-CoV-2 in different populations based on current evidence. METHODS An ESCMID COVID-19 guidelines task force was established by the ESCMID Executive Committee. A small group was established, half appointed by the chair, and the remaining selected with an open call. The panel met virtually once a week. For all decisions, a simple majority vote was used. A list of clinical questions using the PICO (population, intervention, comparison, and outcome) format was developed at the beginning of the process. For each PICO, two panel members performed a literature search focusing on systematic reviews with a third panellist involved in case of inconsistent results. The panel reassessed the PICOs previously defined as priority in the first set of guidelines and decided to address 49 PICO questions, as 6 of them were discarded as outdated/non-clinically relevant. The "Grading of Recommendations Assessment, Development and Evaluation(GRADE)-adoption, adaptation, and de novo development of recommendations (ADOLOPMENT)" evidence-to-decision framework was utilized to produce the guidelines. QUESTIONS ADDRESSED BY THE GUIDELINE AND RECOMMENDATIONS After literature search, we updated 16 PICO questions; these PICOs address the use of antigen-based assays among symptomatic and asymptomatic patients with different ages, COVID-19 severity status or risk for severe COVID-19, time since onset of symptoms/contact with an infectious case, and finally, types of biomaterials used.
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Affiliation(s)
- Paraskevi C Fragkou
- First Department of Critical Care Medicine & Pulmonary Services, Evangelismos General Hospital, National and Kapodistrian University of Athens, Athens, Greece; European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Respiratory Viruses (ESGREV)
| | - Giulia De Angelis
- European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Respiratory Viruses (ESGREV); Dipartimento di Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS - 00168, Rome, Italy
| | - Giulia Menchinelli
- European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Respiratory Viruses (ESGREV); Dipartimento di Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS - 00168, Rome, Italy; Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Fusun Can
- European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Respiratory Viruses (ESGREV); Department of Medical Microbiology, Koc University School of Medicine, Istanbul, Turkey; Koc University IsBank Research Centre for Infectious Diseases (KUISCID), Istanbul, Turkey
| | - Federico Garcia
- European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Respiratory Viruses (ESGREV); Servicio de Microbiología Clínica. Hospital Universitario Clínico San Cecilio. Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain; Centro de Investigación Biomédicaen Red Enfermedades Infecciosas (CIBERINFEC), ISCIII, Madrid, Spain
| | - Florence Morfin-Sherpa
- European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Respiratory Viruses (ESGREV); Laboratory of Virology, Institut des Agents Infectieux, National Reference Centre for respiratory viruses, Hospices Civils de Lyon, Université Claude Bernard Lyon1, Lyon, France
| | - Dimitra Dimopoulou
- European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Respiratory Viruses (ESGREV); Second Department of Paediatrics, "P. and A. Kyriakou" Children's Hospital, National and Kapodistrian University of Athens, Athens, Greece
| | | | - Silvia Zelli
- Dipartimento di Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS - 00168, Rome, Italy
| | - Adolfo de Salazar
- Servicio de Microbiología Clínica. Hospital Universitario Clínico San Cecilio. Instituto de Investigación Biosanitaria, Ibs.GRANADA, Granada, Spain; Centro de Investigación Biomédicaen Red Enfermedades Infecciosas (CIBERINFEC), ISCIII, Madrid, Spain
| | - Rieke Reiter
- Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Centre (UGMLC), Philipps University Marburg, German Centre for Lung Research (DZL), Marburg, Germany
| | - Hannah Janocha
- Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Centre (UGMLC), Philipps University Marburg, German Centre for Lung Research (DZL), Marburg, Germany
| | | | - Jimmy Omony
- Institute for Asthma and Allergy Prevention (IAP), Helmholtz Zentrum Munich, German Research Centre for Environmental Health (GmbH), Munich, Germany
| | - Chrysanthi Skevaki
- European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Respiratory Viruses (ESGREV); Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Centre (UGMLC), Philipps University Marburg, German Centre for Lung Research (DZL), Marburg, Germany.
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29
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Lai S, Liu Y, Fang S, Wu Q, Fan M, Lin D, Lin J, Feng S. Ultrasensitive detection of SARS-CoV-2 antigen using surface-enhanced Raman spectroscopy-based lateral flow immunosensor. JOURNAL OF BIOPHOTONICS 2023:e202300004. [PMID: 36999175 DOI: 10.1002/jbio.202300004] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/04/2023] [Revised: 03/20/2023] [Accepted: 03/28/2023] [Indexed: 06/19/2023]
Abstract
The fast spread and transmission of the coronavirus 2019 (COVID-19) has become one of serious global public health problems. Herein, a surface enhanced Raman spectroscopy-based lateral flow immunoassay (LFA) was developed for the detection of SARS-CoV-2 antigen. Using uniquely designed core-shell nanoparticle with embedded Raman probe molecules as the indicator to reveal the concentration of target protein, excellent quantitative performance with a limit of detection (LOD) of 0.03 ng/mL and detection range of 10-1000 ng/mL can be achieved within 15 min. Besides, the detection of spiked virus protein in human saliva was also performed with a portable Raman spectrometer, proposing the feasibility of the method in practical applications. This easy-to-use, rapid and accurate method would provide a point-of-care testing way as the ideal alternative for current detection requirement of virus-related biomarkers.
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Affiliation(s)
- Shuxia Lai
- Key Laboratory of OptoElectronic Science and Technology for Medicine, Ministry of Education, Fujian Provincial Key Laboratory for Photonics Technology, Fujian Normal University, Fuzhou, Fujian, China
| | - Yi Liu
- Key Laboratory of OptoElectronic Science and Technology for Medicine, Ministry of Education, Fujian Provincial Key Laboratory for Photonics Technology, Fujian Normal University, Fuzhou, Fujian, China
| | - Shubin Fang
- The Cancer Center, Union Hospital, Fujian Medical University, Fuzhou, Fujian, China
| | - Qiong Wu
- College of Physics and Electronic Information Engineering, Minjiang University, Fuzhou, Fujian, China
| | - Min Fan
- Key Laboratory of OptoElectronic Science and Technology for Medicine, Ministry of Education, Fujian Provincial Key Laboratory for Photonics Technology, Fujian Normal University, Fuzhou, Fujian, China
| | - Duo Lin
- Key Laboratory of OptoElectronic Science and Technology for Medicine, Ministry of Education, Fujian Provincial Key Laboratory for Photonics Technology, Fujian Normal University, Fuzhou, Fujian, China
| | - Jizhen Lin
- The Cancer Center, Union Hospital, Fujian Medical University, Fuzhou, Fujian, China
| | - Shangyuan Feng
- Key Laboratory of OptoElectronic Science and Technology for Medicine, Ministry of Education, Fujian Provincial Key Laboratory for Photonics Technology, Fujian Normal University, Fuzhou, Fujian, China
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30
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Akhter N, Sana S, Adnan Ahsan M, Siddique Z, Huraira A, Sana S. Advances in Diagnosis and Treatment for SARS-CoV-2 Variants. Infect Dis (Lond) 2023. [DOI: 10.5772/intechopen.107846] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/31/2023] Open
Abstract
The COVID-19 pandemic’s epidemiological and clinical characteristics have been affected in recent months by the introduction of SARS-CoV-2 variants with unique spikes of protein alterations. These variations can lessen the protection provided by suppressing monoclonal antibodies and vaccines, as well as enhance the frequencies of transmission of the virus and/or the risk of contracting the disease. Due to these mutations, SARS-CoV-2 may be able to proliferate despite increasing levels of vaccination coverage while preserving and enhancing its reproduction efficiency. This is one of the main strategies in tackling the COVID-19 epidemics, the accessibility of precise and trustworthy biomarkers for the SARS-CoV-2 genetic material and also its nucleic acids is important to investigate the disease in suspect communities, start making diagnoses and management in symptomatic or asymptomatic persons, and evaluate authorization of the pathogen after infection. Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) for virus nucleic acid identification is still the most effective method for such uses due to its sensitivity, quickness, high-throughput sequencing capacity, and trustworthiness. It is essential to update the primer and probe sequences to maintain the recognition of recently emerging variations. Concerning viral variations could develop that are dangerously resistant to the immunization induced by the present vaccinations in coronavirus disease 2019. Additionally, the significance of effective public health interventions and vaccination programs will grow if some variations of concern exhibit an increased risk of transmission or toxicity. The international reaction must’ve been immediate and established in science. These results supported ongoing efforts to prevent and identify infection, as well as to describe mutations in vaccine recipients, and they suggest a potential risk of illness following effective immunization and transmission of pathogens with a mutant viral.
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31
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Lian Z, Wu T, Wang H, Chi J, Cheng L, Xie D, Pan X, Hu Y, Tan Z, Chen S, Yang X, Yun Y, Wu W, Li C, Su M, Song Y. At-Home COVID-19 Rapid Antigen Test Down to 0.03 pg mL -1 of Nucleocapsid Protein. SMALL (WEINHEIM AN DER BERGSTRASSE, GERMANY) 2023:e2301162. [PMID: 36988021 DOI: 10.1002/smll.202301162] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/09/2023] [Revised: 03/06/2023] [Indexed: 06/19/2023]
Abstract
Rapid and ultra-sensitive detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical for early screening and management of COVID-19. Currently, the real-time reverse transcription polymerase chain reaction (rRT-PCR) is the primary laboratory method for diagnosing SARS-CoV-2. It is not suitable for at-home COVID-19 diagnostic test due to the long operating time, specific equipment, and professional procedures. Here an all-printed photonic crystal (PC) microarray with portable device for at-home COVID-19 rapid antigen test is reported. The fluorescence-enhanced effect of PC amplifies the fluorescence intensity of the labeled probe, achieving detection of nucleocapsid (N-) protein down to 0.03 pg mL-1 . A portable fluorescence intensity measurement instrument gives the result (negative or positive) by the color of the indicator within 5 s after inserting the reacted PC microarray test card. The N protein in inactivated virus samples (with cycle threshold values of 26.6-40.0) can be detected. The PC microarray provides a general and easy-to-use method for the timely monitoring and eventual control of the global coronavirus pandemic.
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Affiliation(s)
- Zewei Lian
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Tingqing Wu
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Huadong Wang
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Jimei Chi
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Lijun Cheng
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Daixi Xie
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Xiangyu Pan
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Yuming Hu
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Zhiyu Tan
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Sisi Chen
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Xu Yang
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Yang Yun
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Wei Wu
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Chunbao Li
- Peoples Liberat Army Gen Hosp, Med Ctr 4 Dept Orthopaed Med, Beijing, 100853, P. R. China
| | - Meng Su
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
| | - Yanlin Song
- Key Laboratory of Green Printing, Institute of Chemistry, Chinese Academy of Sciences (ICCAS)/Beijing Engineering Research Center of Nanomaterials for Green Printing Technology, Beijing National Laboratory for Molecular Sciences (BNLMS), Beijing, 100190, P. R. China
- University of Chinese Academy of Sciences, Beijing, 100049, P. R. China
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32
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Fan J, Parr S, Kang S, Gupta M. Point-of-care (POC) SARS-CoV-2 antigen detection using functionalized aerosol jet-printed organic electrochemical transistors (OECTs). NANOSCALE 2023; 15:5476-5485. [PMID: 36852643 DOI: 10.1039/d2nr06485e] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/18/2023]
Abstract
The continuous spread of coronavirus disease 2019 (COVID-19) has highlighted the need for simple and reliable diagnostic technologies for point-of-care (POC) virus detection applications. Here, we report a COVID-19 diagnostic platform based on aerosol jet-printed antibody-functionalized organic electrochemical transistors (OECTs) for rapidly identifying severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antigens. Selective sensing of SARS-CoV-2 spike S1 protein is achieved in phosphate-buffered saline (PBS) with a detectable range of 1 fg mL-1 to 1 μg mL-1. We used the sensors to detect the antigens in unprocessed patient nasopharyngeal swab samples in universal transport medium (UTM) and achieved an overall accuracy of 70%. In addition, these patient sample tests clearly demonstrate that our OECT threshold voltage shift is correlated with the sample SARS-CoV-2 viral load. Hence, we have demonstrated an accurate POC biosensor for detecting SARS-CoV-2 antigens, which holds great promise towards developing on-site and at-home rapid SARS-CoV-2 infection screening and COVID-19 prognosis.
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Affiliation(s)
- Jiaxin Fan
- Department of Electrical and Computer Engineering, University of Alberta, Edmonton, Alberta, T6G 1H9, Canada.
| | - Sheldon Parr
- Department of Electrical and Computer Engineering, University of Alberta, Edmonton, Alberta, T6G 1H9, Canada.
| | - Seongdae Kang
- Department of Chemical and Materials, University of Alberta, Edmonton, Alberta, T6G 1H9, Canada
| | - Manisha Gupta
- Department of Electrical and Computer Engineering, University of Alberta, Edmonton, Alberta, T6G 1H9, Canada.
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33
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Lee AS, Kim SM, Kim KR, Park C, Lee DG, Heo HR, Cha HJ, Kim CS. A colorimetric lateral flow immunoassay based on oriented antibody immobilization for sensitive detection of SARS-CoV-2. SENSORS AND ACTUATORS. B, CHEMICAL 2023; 379:133245. [PMID: 36589904 PMCID: PMC9791791 DOI: 10.1016/j.snb.2022.133245] [Citation(s) in RCA: 17] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/06/2022] [Revised: 12/14/2022] [Accepted: 12/24/2022] [Indexed: 06/12/2023]
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The high human-to-human transmission and rapid evolution of SARS-CoV-2 have resulted in a worldwide pandemic. To contain SARS-CoV-2, it is essential to efficiently control the transmission of the virus through the early diagnosis of infected individuals, including asymptomatic people. Therefore, a rapid and accurate assay is vital for the early diagnosis of SARS-CoV-2 in suspected individuals. In this study, we developed a colorimetric lateral flow immunoassay (LFIA) in which a CBP31-BC linker was used to immobilize antibodies on a cellulose membrane in an oriented manner. The developed LFIA enabled sensitive detection of cultured SARS-CoV-2 in 15 min with a detection limit of 5 × 104 copies/mL. The clinical performance of the LFIA for detecting SARS-CoV-2 was evaluated using 19 clinical samples validated by reverse transcription-polymerase chain reaction (RT-PCR). The LFIA detected all the positive and negative samples accurately, corresponding to 100% accuracy. Importantly, patient samples with low viral loads were accurately identified. Thus, the proposed method can provide a useful platform for rapid and accurate point-of-care testing of SARS-CoV-2 in infected individuals to efficiently control the COVID-19 pandemic.
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Affiliation(s)
- Ae Sol Lee
- Graduate School of Biochemistry, Yeungnam University, Gyeongsan 38541, Republic of Korea
| | - Su Min Kim
- Graduate School of Biochemistry, Yeungnam University, Gyeongsan 38541, Republic of Korea
| | - Kyeong Rok Kim
- Graduate School of Biochemistry, Yeungnam University, Gyeongsan 38541, Republic of Korea
| | - Chulmin Park
- Vaccine Bio Research Institute, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 06591, Republic of Korea
| | - Dong-Gun Lee
- Vaccine Bio Research Institute, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 06591, Republic of Korea
- Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 06591, Republic of Korea
| | - Hye Ryoung Heo
- Senotherapy-based Metabolic Disease Control Research Center, Yeungnam University, Gyeongsan 38541, Republic of Korea
| | - Hyung Joon Cha
- Department of Chemical Engineering, Pohang University of Science and Technology, Pohang 37673, Republic of Korea
| | - Chang Sup Kim
- Graduate School of Biochemistry, Yeungnam University, Gyeongsan 38541, Republic of Korea
- School of Chemistry and Biochemistry, Yeungnam University, Gyeongsan 38541, Republic of Korea
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Chirico F, Yıldırım M, Dzieciatkowski T, Dabrowski M, Malysz M, Madziala M, Jaguszewski MJ, Bielski K, Nucera G, Filipiak KJ, Szarpak L. Efficiency rating of SG Diagnostics COVID-19 antigen rapid test kit. Future Virol 2023:10.2217/fvl-2021-0210. [PMID: 37091964 PMCID: PMC10115194 DOI: 10.2217/fvl-2021-0210] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2021] [Accepted: 01/16/2023] [Indexed: 04/25/2023]
Abstract
Aim: Rapid detection is crucial in complementing vaccination to reduce transmission of SARS-CoV-2. Materials & methods: Nasopharyngeal swabs (n = 213) and oropharyngeal swabs (n = 98) were tested. with the antigen rapid test kit. Results: Overall sensitivity (97.96%), specificity (100.00%) and coincidence rate (98.71%) were high, which translated into a positive predictive value of 100.00% and a negative predictive value of 96.64%. Conclusion: Antigen rapid tests have a great potential for screening in different settings to deliver results with high sensitivity and specificity.
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Affiliation(s)
- Francesco Chirico
- Post-graduate School of Occupational Health, Università Cattolica del Sacro Cuore, Rome, Italy
- Health Service Department, Italian State Police, Ministry of the Interior, Milan, Italy
- Author for correspondence:
| | - Murat Yıldırım
- Department of Psychology, Faculty of Science & Letters, Agri Ibrahim Cecen University, Ağrı, Turkey
| | - Tomasz Dzieciatkowski
- Chair & Department of Medical Microbiology, Medical University of Warsaw, Warsaw, Poland
| | - Marek Dabrowski
- Research Unit, Polish Society of Disaster Medicine, Warsaw, Poland
- Chair & Department of Medical Education, Poznan University of Medical Sciences, Poznan, Poland
| | - Marek Malysz
- Research Unit, Polish Society of Disaster Medicine, Warsaw, Poland
- Institute of Outcomes Research, Polonia University, Czestochowa, Poland
| | - Marcin Madziala
- Research Unit, Polish Society of Disaster Medicine, Warsaw, Poland
| | | | - Karol Bielski
- Research Unit, Polish Society of Disaster Medicine, Warsaw, Poland
- Institute of Outcomes Research, Polonia University, Czestochowa, Poland
- Emergency Medical Service, Warsaw, Poland
| | - Gabriella Nucera
- Department of Emergency, Fatebenefratelli Hospital, ASST Fatebenefratelli & Sacco, Milan, Italy
| | - Krzysztof J Filipiak
- Institute of Outcomes Research, Maria Sklodowska-Curie Medical Academy, Warsaw, Poland
| | - Lukasz Szarpak
- Research Unit, Polish Society of Disaster Medicine, Warsaw, Poland
- Institute of Outcomes Research, Maria Sklodowska-Curie Medical Academy, Warsaw, Poland
- Research Unit, Maria Sklodowska-Curie Bialystok Oncology Center, Bialystok, Poland
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35
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Mohammadie ZE, Akhlaghi S, Samaeinasab S, Shaterzadeh-Bojd S, Jamialahmadi T, Sahebkar A. Clinical performance of rapid antigen tests in comparison to RT-PCR for SARS-COV-2 diagnosis in Omicron variant: A systematic review and meta-analysis. Rev Med Virol 2023; 33:e2428. [PMID: 36790832 DOI: 10.1002/rmv.2428] [Citation(s) in RCA: 11] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/30/2022] [Revised: 01/21/2023] [Accepted: 01/29/2023] [Indexed: 02/16/2023]
Abstract
The Omicron variant of concern has a high level of mutations in different genes that has raised awareness about the performance of immunological products such as vaccines and antigen detection kits. In this systematic review and meta-analysis, we investigated whether Omicron had a significant influence on rapid antigen test (RAT) performance in comparison to PCR. We registered this systematic review and meta-analysis in PROSPERO with the registration number CRD42022355510. We searched PubMed, Scopus, Embase, and Web of Science databases systematically to 1 August 2022. After article screening, we assessed the quality of the included studies based on the JBI checklist. Following data extraction, we performed a meta-analysis using R software. We included 18 qualified articles presenting sufficient data about RATs performance in comparison to RT-PCR in Omicron infections. The pooled specificity and sensitivity of RATs were 1.000 (0.997-1.000) and 0.671 (0.595-0.721), respectively. The FDA-approved kits showed a better performance than WHO-approved ones with a sensitivity of 0.728 (0.620-0.815). The use of RATs with nasal swabs showed a higher sensitivity compared with nasopharyngeal swabs. The sensitivity for samples with a CT-value >25 was 0.108 (0.048-0.227). Rapid antigen tests show impaired performance for COVID-19 diagnosis when the Omicron variant is circulating, particularly in samples with low viral loads.
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Affiliation(s)
- Zahra Eslami Mohammadie
- Student Research Committee, Faculty of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Saeed Akhlaghi
- Department of Biostatistics, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Saeed Samaeinasab
- Immunology Board for Transplantation and Cell-Based Therapeutics (Immuno_TACT), Universal Scientific Education and Research Network (USERN), Tehran, Iran
| | - Shakiba Shaterzadeh-Bojd
- Student Research Committee, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Tannaz Jamialahmadi
- Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Amirhossein Sahebkar
- Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.,Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.,School of Medicine, The University of Western Australia, Perth, Australia.,Department of Biotechnology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
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Brogna C, Costanzo V, Brogna B, Bisaccia DR, Brogna G, Giuliano M, Montano L, Viduto V, Cristoni S, Fabrowski M, Piscopo M. Analysis of Bacteriophage Behavior of a Human RNA Virus, SARS-CoV-2, through the Integrated Approach of Immunofluorescence Microscopy, Proteomics and D-Amino Acid Quantification. Int J Mol Sci 2023; 24:3929. [PMID: 36835341 PMCID: PMC9965620 DOI: 10.3390/ijms24043929] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/17/2022] [Revised: 02/08/2023] [Accepted: 02/11/2023] [Indexed: 02/18/2023] Open
Abstract
SARS-CoV-2, one of the human RNA viruses, is widely studied around the world. Significant efforts have been made to understand its molecular mechanisms of action and how it interacts with epithelial cells and the human microbiome since it has also been observed in gut microbiome bacteria. Many studies emphasize the importance of surface immunity and also that the mucosal system is critical in the interaction of the pathogen with the cells of the oral, nasal, pharyngeal, and intestinal epithelium. Recent studies have shown how bacteria in the human gut microbiome produce toxins capable of altering the classical mechanisms of interaction of viruses with surface cells. This paper presents a simple approach to highlight the initial behavior of a novel pathogen, SARS-CoV-2, on the human microbiome. The immunofluorescence microscopy technique can be combined with spectral counting performed at mass spectrometry of viral peptides in bacterial cultures, along with identification of the presence of D-amino acids within viral peptides in bacterial cultures and in patients' blood. This approach makes it possible to establish the possible expression or increase of viral RNA viruses in general and SARS-CoV-2, as discussed in this study, and to determine whether or not the microbiome is involved in the pathogenetic mechanisms of the viruses. This novel combined approach can provide information more rapidly, avoiding the biases of virological diagnosis and identifying whether a virus can interact with, bind to, and infect bacteria and epithelial cells. Understanding whether some viruses have bacteriophagic behavior allows vaccine therapies to be focused either toward certain toxins produced by bacteria in the microbiome or toward finding inert or symbiotic viral mutations with the human microbiome. This new knowledge opens a scenario on a possible future vaccine: the probiotics vaccine, engineered with the right resistance to viruses that attach to both the epithelium human surface and gut microbiome bacteria.
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Affiliation(s)
- Carlo Brogna
- Department of Research, Craniomed Group Facility Srl., 20091 Bresso, Italy
| | - Vincenzo Costanzo
- Biogem, Institute of Molecular Biology and Genetics, 83031 Ariano Irpino, Italy
| | - Barbara Brogna
- Department of Radiology, Moscati Hospital, Contrada Amoretta, 83100 Avellino, Italy
| | | | - Giancarlo Brogna
- Department of Research, Craniomed Group Facility Srl., 20091 Bresso, Italy
| | - Marino Giuliano
- Marsanconsulting Srl. Public Health Company, Via dei Fiorentini, 80133 Napoli, Italy
| | - Luigi Montano
- Andrology Unit and Service of LifeStyle Medicine in Uro-Andrology, Local Health Authority (ASL), 84124 Salerno, Italy
| | - Valentina Viduto
- Long COVID-19 Foundation, Brookfield Court, Garforth, Leeds LS25 1NB, UK
| | | | - Mark Fabrowski
- Department of Emergency Medicine, Royal Sussex County Hospital, University Hospitals Sussex, Eastern Road, Brighton BN2 5BE, UK
| | - Marina Piscopo
- Department of Biology, University of Naples Federico II, 80126 Napoli, Italy
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Sabat J, Subhadra S, Rath S, Ho LM, Satpathy T, Pattnaik D, Pati S, Turuk J. A comparison of SARS-CoV-2 rapid antigen testing with realtime RT-PCR among symptomatic and asymptomatic individuals. BMC Infect Dis 2023; 23:87. [PMID: 36759762 PMCID: PMC9909630 DOI: 10.1186/s12879-022-07969-0] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2021] [Accepted: 12/23/2022] [Indexed: 02/11/2023] Open
Abstract
BACKGROUND Identification of SARS-CoV-2 positive patients with rapid and cost-effective test methods is the key for isolating infected individuals, interrupting the transmission chain, and thus, containment of the CoVID-19 disease. In this regard, Rapid Antigen Test (RAT) plays an important role at point of care testing but the low sensitivity attributing towards escape of positive cases is reported as a major disadvantage of RAT which led us to evaluate a RAT kit among symptomatic and asymptomatic individuals suspected of CoVID-19. METHODS We analyzed 329 parallel nasopharyngeal swabs for RAT (Zydus Cadila, India) at the point of collection in a hospital-based facility and RealTime RT-PCR in the laboratory. The performance parameters were analyzed by evaluating the specificity, sensitivity, Negative Predictive Value (NPV), Positive Predictive Value (PPV), and Kappa coefficient. RESULTS The sensitivity and specificity were found to be 75.17% and 98.89% respectively. Positive Predictive value was 98.25% and the negative predictive value was 82.79%. The accuracy between the two techniques was found to be 88.14% with a kappa coefficient of 0.756 (SE: 0.036 and CI at 95%: 0.686 to 0.826) with a good strength of agreement (0.61-0.80) between the two testing techniques. Among the false-negative cases, 22 (59.5%) were asymptomatic having the Cycle Threshold (Ct) range 27 to 32.9 including 12 cases with a history of close contact with the known positive cases (i.e. household contact). The remaining 15 cases (40.5%) were symptomatic having low to moderate Ct values. CONCLUSION It is observed from the results that the false negative result for symptomatic individuals is a matter of concern as it was noted in 4 cases of our study subjects who required hospitalisation later. Also the positives among asymptomatic contacts are important from epidemiological point of view for isolation and curtailing the infection from spreading in a community. These results support the fact that RAT showing sensitivity below 80% can be used for mass screening purposes with provision for additional testing in case of false negative with symptomatic individuals. Also false-negative results should be interpreted cautiously considering the epidemiological link as well as the clinical condition of the patients.
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Affiliation(s)
- Jyotsnamayee Sabat
- Virus Research and Diagnostic Laboratory (VRDL), ICMR-Regional Medical Research Centre, Chandrasekharpur, Bhubaneswar, Odisha 751023 India
| | - Subhra Subhadra
- Virus Research and Diagnostic Laboratory (VRDL), ICMR-Regional Medical Research Centre, Chandrasekharpur, Bhubaneswar, Odisha 751023 India
| | - Sonalika Rath
- Virus Research and Diagnostic Laboratory (VRDL), ICMR-Regional Medical Research Centre, Chandrasekharpur, Bhubaneswar, Odisha 751023 India
| | - Lal Mohan Ho
- Virus Research and Diagnostic Laboratory (VRDL), ICMR-Regional Medical Research Centre, Chandrasekharpur, Bhubaneswar, Odisha 751023 India
| | | | | | - Sanghamitra Pati
- Virus Research and Diagnostic Laboratory (VRDL), ICMR-Regional Medical Research Centre, Chandrasekharpur, Bhubaneswar, Odisha 751023 India
| | - Jyotirmayee Turuk
- Virus Research and Diagnostic Laboratory (VRDL), ICMR-Regional Medical Research Centre, Chandrasekharpur, Bhubaneswar, Odisha 751023 India
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Al‐Hashimi OTM, AL‐Ansari WIA, Abbas SA, Jumaa DS, Hammad SA, Hammoudi FA, Allawi AAD. The sensitivity and specificity of COVID-19 rapid anti-gene test in comparison to RT-PCR test as a gold standard test. J Clin Lab Anal 2023; 37:e24844. [PMID: 36725342 PMCID: PMC9978065 DOI: 10.1002/jcla.24844] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/02/2022] [Revised: 12/30/2022] [Accepted: 01/19/2023] [Indexed: 02/03/2023] Open
Abstract
BACKGROUND Coronavirus disease 2019 (COVID-19) is a modern infectious disease, first identified in December 2019 in Wuhan, China. The etiology is via severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in a pandemic manner. The study aimed to compare between RT-PCR and rapid anti-gene tests for COVID-19 with regard to sensitivity and specificity. METHODS This is a cohort hospital-based study done during the period of July to September 2020. Both rapid anti-gene test kit (SARS-CoV-2) and RT-qPCR were used for the detection of COVID-19 in suspected cases. RESULTS A total of 148 cases were tested using both the RT-qPCR and rapid test. Twenty-nine (19.6%) of these cases had positive results for RT-qPCR and 119 (80.4%) were negative, whereas 52 (35.1%) patients were positive to rapid anti-gene test and 96 (64.9%) of them negative. The sensitivity of the rapid test was 37.9%, the specificity was 65.5% and the accuracy was 64.44%. Rapid IgG test was positive in 47 (31.8) of cases. Although, rapid IgM test was positive in 18 (12.2%). The rapid IgG test was more sensitive than rapid IgM (Sensitivity 34.48% vs. 3.45%), but it was less specific than rapid IgM test (Specificity 68.91% vs. 85.71%). CONCLUSION We cannot consider rapid anti-gene test alone as a diagnostic method for COVID-19. We should also conduct RT-PCR test and other investigations like imaging CT scan of chest to confirm the diagnosis. The rapid IgG test is more sensitive than rapid IgM, but it was less specific.
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Karlafti E, Tsavdaris D, Kotzakioulafi E, Kaiafa G, Savopoulos C, Netta S, Michalopoulos A, Paramythiotis D. The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis. Life (Basel) 2023; 13:281. [PMID: 36836639 PMCID: PMC9961889 DOI: 10.3390/life13020281] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/27/2022] [Revised: 01/15/2023] [Accepted: 01/17/2023] [Indexed: 01/20/2023] Open
Abstract
INTRODUCTION Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of coronavirus disease 2019 (COVID-19), a disease that quickly spread into a pandemic. As such, management of the COVID-19 pandemic is deemed necessary, and it can be achieved by using reliable diagnostic tests for SARS-CoV-2. The gold standard for the diagnosis of SARS-CoV-2 is a molecular detection test using the reverse transcription polymerase chain reaction technique (rt-PCR), which is characterized by various disadvantages in contrast with the self-taken nasal rapid antigen tests that produce results faster, have lower costs and do not require specialized personnel. Therefore, the usefulness of self-taken rapid antigen tests is indisputable in disease management, facilitating both the health system and the examinees. Our systematic review aims to access the diagnostic accuracy of the self-taken nasal rapid antigen tests. METHODS This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was used to assess the risk of bias in the included studies. All the studies included in this systematic review were found after searching the two databases, Scopus and PubΜed. All but original articles were excluded from this systematic review, while all the studies concerning self-taken rapid antigen tests with a nasal sample and using rt-PCR as a reference test were included. Meta-analysis results and plots were obtained using RevMan software and the MetaDTA website. RESULTS All 22 studies included in this meta-analysis demonstrated a specificity of self-taken rapid antigen tests greater than 98%, which exceeds the minimum required yield for the diagnosis of SARS-CoV-2, according to the WHO. Notwithstanding, the sensitivity varies (from 40% to 98.7%), which makes them in some cases unsuitable for the diagnosis of positive cases. In the majority of the studies, the minimum required performance set by the WHO was achieved, which is 80% compared with rt-PCR tests. The pooled sensitivity of self-taken nasal rapid antigen tests was calculated as 91.1% and the pooled specificity was 99.5%. CONCLUSIONS In conclusion, self-taken nasal rapid antigen tests have many advantages over rt-PCR tests, such as those related to the rapid reading of the results and their low cost. They also have considerable specificity and some self-taken rapid antigen test kits also have remarkable sensitivity. Consequently, self-taken rapid antigen tests have a wide range of utility but are not able to completely replace rt-PCR tests.
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Affiliation(s)
- Eleni Karlafti
- Emergency Department, University General Hospital of Thessaloniki AHEPA, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
- 1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
| | - Dimitrios Tsavdaris
- First Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece
| | - Evangelia Kotzakioulafi
- 1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
| | - Georgia Kaiafa
- 1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
| | - Christos Savopoulos
- 1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
| | - Smaro Netta
- First Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece
| | - Antonios Michalopoulos
- First Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece
| | - Daniel Paramythiotis
- First Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece
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40
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Karlafti E, Tsavdaris D, Kotzakioulafi E, Kaiafa G, Savopoulos C, Netta S, Michalopoulos A, Paramythiotis D. The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis. Life (Basel) 2023; 13:281. [DOI: https:/doi.org/10.3390/life13020281] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/16/2025] Open
Abstract
Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of coronavirus disease 2019 (COVID-19), a disease that quickly spread into a pandemic. As such, management of the COVID-19 pandemic is deemed necessary, and it can be achieved by using reliable diagnostic tests for SARS-CoV-2. The gold standard for the diagnosis of SARS-CoV-2 is a molecular detection test using the reverse transcription polymerase chain reaction technique (rt-PCR), which is characterized by various disadvantages in contrast with the self-taken nasal rapid antigen tests that produce results faster, have lower costs and do not require specialized personnel. Therefore, the usefulness of self-taken rapid antigen tests is indisputable in disease management, facilitating both the health system and the examinees. Our systematic review aims to access the diagnostic accuracy of the self-taken nasal rapid antigen tests. Methods: This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was used to assess the risk of bias in the included studies. All the studies included in this systematic review were found after searching the two databases, Scopus and PubΜed. All but original articles were excluded from this systematic review, while all the studies concerning self-taken rapid antigen tests with a nasal sample and using rt-PCR as a reference test were included. Meta-analysis results and plots were obtained using RevMan software and the MetaDTA website. Results: All 22 studies included in this meta-analysis demonstrated a specificity of self-taken rapid antigen tests greater than 98%, which exceeds the minimum required yield for the diagnosis of SARS-CoV-2, according to the WHO. Notwithstanding, the sensitivity varies (from 40% to 98.7%), which makes them in some cases unsuitable for the diagnosis of positive cases. In the majority of the studies, the minimum required performance set by the WHO was achieved, which is 80% compared with rt-PCR tests. The pooled sensitivity of self-taken nasal rapid antigen tests was calculated as 91.1% and the pooled specificity was 99.5%. Conclusions: In conclusion, self-taken nasal rapid antigen tests have many advantages over rt-PCR tests, such as those related to the rapid reading of the results and their low cost. They also have considerable specificity and some self-taken rapid antigen test kits also have remarkable sensitivity. Consequently, self-taken rapid antigen tests have a wide range of utility but are not able to completely replace rt-PCR tests.
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Affiliation(s)
- Eleni Karlafti
- Emergency Department, University General Hospital of Thessaloniki AHEPA, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
- 1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
| | - Dimitrios Tsavdaris
- First Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece
| | - Evangelia Kotzakioulafi
- 1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
| | - Georgia Kaiafa
- 1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
| | - Christos Savopoulos
- 1st Propaedeutic Department of Internal Medicine, AHEPA University General Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
| | - Smaro Netta
- First Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece
| | - Antonios Michalopoulos
- First Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece
| | - Daniel Paramythiotis
- First Propaedeutic Surgery Department, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece
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He J, Zhu S, Zhou J, Jiang W, Yin L, Su L, Zhang X, Chen Q, Li X. Rapid detection of SARS-CoV-2: The gradual boom of lateral flow immunoassay. Front Bioeng Biotechnol 2023; 10:1090281. [PMID: 36704307 PMCID: PMC9871317 DOI: 10.3389/fbioe.2022.1090281] [Citation(s) in RCA: 12] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2022] [Accepted: 12/13/2022] [Indexed: 01/12/2023] Open
Abstract
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is still in an epidemic situation, which poses a serious threat to the safety of people and property. Rapid diagnosis and isolation of infected individuals are one of the important methods to control virus transmission. Existing lateral flow immunoassay techniques have the advantages of rapid, sensitive, and easy operation, and some new options have emerged with the continuous development of nanotechnology. Such as lateral flow immunoassay test strips based on colorimetric-fluorescent dual-mode and gold nanoparticles, Surface Enhanced Raman Scattering, etc., these technologies have played an important role in the rapid diagnosis of COVID-19. In this paper, we summarize the current research progress of lateral flow immunoassay in the field of Severe Acute Respiratory Syndrome Coronavirus 2 infection diagnosis, analyze the performance of Severe Acute Respiratory Syndrome Coronavirus 2 lateral flow immunoassay products, review the advantages and limitations of different detection methods and markers, and then explore the competitive CRISPR-based nucleic acid chromatography detection method. This method combines the advantages of gene editing and lateral flow immunoassay and can achieve rapid and highly sensitive lateral flow immunoassay detection of target nucleic acids, which is expected to be the most representative method for community and clinical point-of-care testing. We hope that researchers will be inspired by this review and strive to solve the problems in the design of highly sensitive targets, the selection of detection methods, and the enhancement of CRISPR technology, to truly achieve rapid, sensitive, convenient, and specific detection of novel coronaviruses, thus promoting the development of novel coronavirus diagnosis and contributing our modest contribution to the world's fight against epidemics.
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Wey L, Masetto T, Spaeth A, Brehm J, Kochem C, Reinhart M, Müller H, Kempin U, Lorenz F, Peter C, Grimmler M. Bioinformatical Design and Performance Evaluation of a Nucleocapsid- and an RBD-Based Particle Enhanced Turbidimetric Immunoassay (PETIA) to Quantify the Wild Type and Variants of Concern-Derived Immunoreactivity of SARS-CoV-2. Biomedicines 2023; 11:160. [PMID: 36672668 PMCID: PMC9855841 DOI: 10.3390/biomedicines11010160] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2022] [Revised: 12/29/2022] [Accepted: 12/31/2022] [Indexed: 01/11/2023] Open
Abstract
Since SARS-CoV-2 emerged in December 2019 in Wuhan, the resulting pandemic has paralyzed the economic and cultural life of the world. Variants of concern (VOC) strongly increase pressure on public health systems. Rapid, easy-to-use, and cost-effective assays are essential to manage the pandemic. Here we present a bioinformatical approach for the fast and efficient design of two innovative serological Particle Enhanced Turbidimetric Immunoassays (PETIA) to quantify the SARS-CoV-2 immunoresponse. To confirm bioinformatical assumptions, an S-RBD- and a Nucleocapsid-based PETIA were produced. Sensitivity and specificity were compared for 95 patient samples using a BioMajesty™ fully automated analyzer. The S-RBD-based PETIA showed necessary specificity (98%) over the N protein-based PETIA (21%). Further, the reactivity and cross-reactivity of the RBD-based PETIA towards variant-derived antibodies of SARS-CoV-2 were assessed by a quenching inhibition test. The inhibition kinetics of the S-RBD variants Alpha, Beta, Delta, Gamma, Kappa, and Omicron were evaluated. In summary, we showed that specific and robust PETIA immunoassays can be rapidly designed and developed. The quantification of the SARS-CoV-2-related immunoresponse of variants (Alpha to Kappa) is possible using specific RBD assays. In contrast, Omicron revealed lower cross-reactivity (approx. 50%). To ensure the quantification of the Omicron variant, modified immunoassays appear to be necessary.
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Affiliation(s)
- Leoni Wey
- DiaSys Diagnostic Systems GmbH, Alte Str. 9, 65558 Holzheim, Germany
- Hochschule Fresenius Gem. Trägergesellschaft mbH, University of Applied Sciences, Limburger Str. 2, 65510 Idstein, Germany
| | - Thomas Masetto
- DiaSys Diagnostic Systems GmbH, Alte Str. 9, 65558 Holzheim, Germany
- Institut für Molekulare Medizin I, Heinrich-Heine-Universität, Universitätsstr. 1, 40225 Düsseldorf, Germany
| | - Alexander Spaeth
- MVZ Medizinische Labore Dessau Kassel GmbH, Bauhüttenstr. 6, 06847 Dessau-Roßlau, Germany
| | - Jessica Brehm
- MVZ Medizinische Labore Dessau Kassel GmbH, Bauhüttenstr. 6, 06847 Dessau-Roßlau, Germany
| | - Christian Kochem
- DiaSys Diagnostic Systems GmbH, Alte Str. 9, 65558 Holzheim, Germany
| | | | - Holger Müller
- DiaSys Diagnostic Systems GmbH, Alte Str. 9, 65558 Holzheim, Germany
| | - Uwe Kempin
- pes Medizinische Diagnosesysteme GmbH, Hauptstr. 103, 04416 Markkleeberg, Germany
| | - Franziska Lorenz
- MVZ Medizinische Labore Dessau Kassel GmbH, Bauhüttenstr. 6, 06847 Dessau-Roßlau, Germany
| | - Christoph Peter
- Institut für Molekulare Medizin I, Heinrich-Heine-Universität, Universitätsstr. 1, 40225 Düsseldorf, Germany
| | - Matthias Grimmler
- DiaSys Diagnostic Systems GmbH, Alte Str. 9, 65558 Holzheim, Germany
- Hochschule Fresenius Gem. Trägergesellschaft mbH, University of Applied Sciences, Limburger Str. 2, 65510 Idstein, Germany
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Mungmunpuntipantip R, Wiwanitkit V. Cost–Utility analysis for rapid severe acute respiratory syndrome-coronavirus-2 antigen detection assay in comparison versus real-time reverse transcription-polymerase chain reaction assay for laboratory diagnosis of coronavirus disease -2019. BIOMEDICAL AND BIOTECHNOLOGY RESEARCH JOURNAL (BBRJ) 2023. [DOI: 10.4103/bbrj.bbrj_301_22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 03/18/2023]
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Dofuor AK, Quartey NKA, Osabutey AF, Boateng BO, Lutuf H, Osei JHN, Ayivi-Tosuh SM, Aiduenu AF, Ekloh W, Loh SK, Opoku MJ, Aidoo OF. The Global Impact of COVID-19: Historical Development, Molecular Characterization, Drug Discovery and Future Directions. CLINICAL PATHOLOGY (THOUSAND OAKS, VENTURA COUNTY, CALIF.) 2023; 16:2632010X231218075. [PMID: 38144436 PMCID: PMC10748929 DOI: 10.1177/2632010x231218075] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/10/2023] [Accepted: 11/16/2023] [Indexed: 12/26/2023]
Abstract
In December 2019, an outbreak of a respiratory disease called the coronavirus disease 2019 (COVID-19) caused by a new coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China. The SARS-CoV-2, an encapsulated positive-stranded RNA virus, spread worldwide with disastrous consequences for people's health, economies, and quality of life. The disease has had far-reaching impacts on society, including economic disruption, school closures, and increased stress and anxiety. It has also highlighted disparities in healthcare access and outcomes, with marginalized communities disproportionately affected by the SARS-CoV-2. The symptoms of COVID-19 range from mild to severe. There is presently no effective cure. Nevertheless, significant progress has been made in developing COVID-19 vaccine for different therapeutic targets. For instance, scientists developed multifold vaccine candidates shortly after the COVID-19 outbreak after Pfizer and AstraZeneca discovered the initial COVID-19 vaccines. These vaccines reduce disease spread, severity, and mortality. The addition of rapid diagnostics to microscopy for COVID-19 diagnosis has proven crucial. Our review provides a thorough overview of the historical development of COVID-19 and molecular and biochemical characterization of the SARS-CoV-2. We highlight the potential contributions from insect and plant sources as anti-SARS-CoV-2 and present directions for future research.
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Affiliation(s)
- Aboagye Kwarteng Dofuor
- Department of Biological Sciences, School of Natural and Environmental Sciences, University of Environment and Sustainable Development, Somanya, Ghana
| | - Naa Kwarley-Aba Quartey
- Department of Food Science and Technology, Faculty of Biosciences, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
| | | | - Belinda Obenewa Boateng
- Coconut Research Program, Oil Palm Research Institute, Council for Scientific and Industrial Research, Sekondi-Takoradi, Ghana
| | - Hanif Lutuf
- Crop Protection Division, Oil Palm Research Institute, Council for Scientific and Industrial Research, Kade, Ghana
| | - Joseph Harold Nyarko Osei
- Department of Parasitology, Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Accra, Ghana
| | - Selina Mawunyo Ayivi-Tosuh
- Department of Biochemistry, School of Life Sciences, Northeast Normal University, Changchun, Jilin Province, China
| | - Albert Fynn Aiduenu
- West African Centre for Cell Biology of Infectious Pathogens, University of Ghana, Legon, Accra, Ghana
| | - William Ekloh
- Department of Biochemistry, School of Biological Sciences, College of Agriculture and Natural Sciences, University of Cape Coast, Cape Coast, Ghana
| | - Seyram Kofi Loh
- Department of Built Environment, School of Sustainable Development, University of Environment and Sustainable Development, Somanya, Ghana
| | - Maxwell Jnr Opoku
- Department of Biological Sciences, School of Natural and Environmental Sciences, University of Environment and Sustainable Development, Somanya, Ghana
| | - Owusu Fordjour Aidoo
- Department of Biological Sciences, School of Natural and Environmental Sciences, University of Environment and Sustainable Development, Somanya, Ghana
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Fu H, Sun L, Zhu J. Detection of Antibody versus Antigen, Optimal Option of Different Serological Assays Based Tests for COVID-19 Diagnosis: A Meta-Analysis. IRANIAN JOURNAL OF PUBLIC HEALTH 2023; 52:23-36. [PMID: 36824236 PMCID: PMC9941426 DOI: 10.18502/ijph.v52i1.11662] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/22/2022] [Accepted: 10/11/2022] [Indexed: 01/19/2023]
Abstract
Background In this study, the diagnostic efficacy of antigen test and antibody test were assessed. Additionally, the difference of sensitivity, specificity, and diagnostic odds ratio were compared concerning efficacy of antibody test versus antigen test for Corona Virus Disease 2019 (COVID-19) diagnosis. Methods Online databases were searched for full-text publications and STATA software was used for data pooling and analysis before Sep 1st, 2022. Forrest plot was used to show the pooled sensitivity, specificity and diagnostic odds ratio. Combined receiver operating characteristic (ROC) curve was used to show the area of under curve of complex data. Results Overall, 25 studies were included. The sensitivity (0.68, 95% CI: 0.53-0.80) and specificity (0.99, 95% CI: 0.98-0.99) in antibody or antigen was calculated. The time point of test lead to heterogeneity. The area under curve (AUC) was 0.98 (95% CI: 0.96-0.99), and the diagnostic odds ratio (DOR) was 299.54 (95% CI: 135.61-661.64). Subgroup analysis indicated antibody test with sensitivity (0.59, 95% CI: 0.44-0.73) and specificity (0.98, 95% CI: 0.95-0.99) and antigen test with sensitivity of 0.77 (95% CI: 0.53-0.91) and specificity of 0.99 (95% CI: 0.98-1.00). Higher AUC and DOR were proved in antigen test. Conclusion The present study compared the efficacy of antibody test versus antigen test for COVID-19 diagnosis. Better diagnostic efficacy, lower heterogeneity, and less publication bias of rapid antigen testing was suggested in this study. This study would help us to make better strategy about choosing rapid and reliable testing method in diagnosis of the COVID-19 disease.
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Affiliation(s)
- Haiyan Fu
- Department of Clinical Laboratory, Yantaishan Hospital, Yantai 264001, Shandong Province, PR China
| | - Lin Sun
- Department of Clinical Laboratory, Yantaishan Hospital, Yantai 264001, Shandong Province, PR China
| | - Jingwei Zhu
- Department of Clinical Laboratory, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai 264000, Shandong Province, PR China,Corresponding Author:
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Performance Evaluation of STANDARD Q COVID/FLU Ag Combo for Detection of SARS-CoV-2 and Influenza A/B. Diagnostics (Basel) 2022; 13:diagnostics13010032. [PMID: 36611324 PMCID: PMC9818676 DOI: 10.3390/diagnostics13010032] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2022] [Revised: 12/20/2022] [Accepted: 12/21/2022] [Indexed: 12/25/2022] Open
Abstract
We evaluated the performance of the STANDARD Q COVID/FLU Ag Combo test (Q Ag combo test) for the detection of SARS-CoV-2, influenza A, and influenza B using a single point-of-care device compared with real-time PCR. A total of 408 individuals, 55 positives with SARS-CoV-2, 90 with influenza A, 68 with influenza B, and 195 negatives for all viruses, participated. The Q Ag combo test demonstrated a high level of sensitivity of 92.73% and a specificity of 99.49% for the detection of SARS-CoV-2. When the number of days from symptom onset (DSO) was restricted to 0 < DSO ≤ 6, the sensitivity of the Q Ag combo test to detect SARS-CoV-2 was 100%, and when the Ct value of RdRp was ≤20, the sensitivity to detect SARS-CoV-2 was 93.10%. The Q Ag combo test results also demonstrated a sensitivity of 92.22% and a specificity of 100% for influenza A, a sensitivity of 91.18%, and a specificity of 99.49% for influenza B. The agreement analysis of the Q Ag combo test with the RT-PCR results demonstrated excellent outcomes, making it useful and efficient for the detection of SARS-CoV-2, influenza A, and influenza B.
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Chen Y, Ma Y, Han Y, Diao Z, Chang L, Li J, Zhang R. Evaluation of Four Strategies for SARS-CoV-2 Detection: Characteristics and Prospects. Microbiol Spectr 2022; 10:e0214322. [PMID: 36287010 PMCID: PMC9769534 DOI: 10.1128/spectrum.02143-22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2022] [Accepted: 09/27/2022] [Indexed: 01/06/2023] Open
Abstract
The pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has posed an enormous burden on the global public health system and has had disastrous socioeconomic consequences. Currently, single sampling tests, 20-in-1 pooling tests, nucleic acid point-of-care tests (POCTs), and rapid antigen tests are implemented in different scenarios to detect SARS-CoV-2, but a comprehensive evaluation of them is scarce and remains to be explored. In this study, 3 SARS-CoV-2 inactivated cell culture supernatants were used to evaluate the analytical performance of these strategies. Additionally, 5 recombinant SARS-CoV-2 nucleocapsid (N) proteins were also used for rapid antigen tests. For the wild-type (WT), Delta, and Omicron strains, the lowest inactivated virus concentrations to achieve 100% detection rates of single sampling tests ranged between 1.28 × 102 to 1.02 × 103, 1.28 × 102 to 4.10 × 103, and 1.28 × 102 to 2.05 × 103 copies/mL. The 20-in-1 pooling tests ranged between 1.30 × 102 to 1.04 × 103, 5.19 × 102 to 2.07 × 103, and 2.59 × 102 to 1.04 × 103 copies/mL. The nucleic acid POCTs were all 1.42 × 103 copies/mL. The rapid antigen tests ranged between 2.84 × 105 to 7.14 × 106, 8.68 × 104 to 7.14 × 106, and 1.12 × 105 to 3.57 × 106 copies/mL. For the WT, Delta AY.2, Delta AY.1/AY.3, Omicron BA.1, and Omicron BA.2 recombinant N proteins, the lowest concentrations to achieve 100% detection rates of rapid antigen tests ranged between 3.47 to 142.86, 1.74 to 142.86, 3.47 to 142.86, 3.47 to 142.86, and 5.68-142.86 ng/mL, respectively. This study provided helpful insights into the scientific deployment of tests and recommended the full-scale consideration of the testing purpose, resource availability, cost performance, result rapidity, and accuracy to facilitate a profound pathway toward the long-term surveillance of coronavirus disease 2019 (COVID-19). IMPORTANCE In the study, we reported an evaluation of 4 detection strategies implemented in different scenarios for SARS-CoV-2 detection: single sampling tests, 20-in-1 pooling tests, nucleic acid point-of-care tests, and rapid antigen tests. 3 SARS-CoV-2-inactivated SARS-CoV-2 cell culture supernatants and 5 recombinant SARS-CoV-2 nucleocapsid proteins were used for evaluation. In this analysis, we found that for the WT, Delta, and Omicron supernatants, the lowest concentrations to achieve 100% detection rates of single sampling tests ranged between 1.28 × 102 to 1.02 × 103, 1.28 × 102 to 4.10 × 103, and 1.28 × 102 to 2.05 × 103 copies/mL. The 20-in-1 pooling tests ranged between 1.30 × 102 to 1.04 × 103, 5.19 × 102 to 2.07 × 103, and 2.59 × 102 to 1.04 × 103 copies/mL. The nucleic acid POCTs were all 1.42 × 103 copies/mL. The rapid antigen tests ranged between 2.84 × 105 to 7.14 × 106, 8.68 × 104 to 7.14 × 106, and 1.12 × 105 to 3.57 × 106 copies/mL. For the WT, Delta AY.2, Delta AY.1/AY.3, Omicron BA.1, and Omicron BA.2 recombinant N proteins, the lowest concentrations to achieve 100% detection rates of rapid antigen tests ranged between 3.47 to 142.86, 1.74 to 142.86, 3.47 to 142.86, 3.47 to 142.86, and 5.68 to 142.86 ng/mL, respectively.
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Affiliation(s)
- Yuqing Chen
- National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, People’s Republic of China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
- Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, People’s Republic of China
| | - Yu Ma
- National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, People’s Republic of China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
- Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, People’s Republic of China
| | - Yanxi Han
- National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, People’s Republic of China
- Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, People’s Republic of China
| | - Zhenli Diao
- National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, People’s Republic of China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
- Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, People’s Republic of China
| | - Lu Chang
- National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, People’s Republic of China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
- Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, People’s Republic of China
| | - Jinming Li
- National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, People’s Republic of China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
- Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, People’s Republic of China
| | - Rui Zhang
- National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, People’s Republic of China
- Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
- Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, People’s Republic of China
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Diagnostic accuracy of a SARS-CoV-2 rapid antigen test among military and civilian personnel of an Air Force airport in central Italy. PLoS One 2022; 17:e0277904. [PMID: 36441672 PMCID: PMC9704652 DOI: 10.1371/journal.pone.0277904] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2022] [Accepted: 11/04/2022] [Indexed: 11/29/2022] Open
Abstract
BACKGROUND Most SARS-CoV-2 rapid antigen detection tests (RADTs) validation studies have been performed on specimens from COVID-19 patients and negative controls or from mostly symptomatic individuals. Herein we evaluated the diagnostic accuracy of AFIAS COVID-19 Ag, hereinafter denominated as AFIAS, during a COVID-19 screening program surveillance testing conducted among personnel of an Italian military airport. METHODS Nasopharyngeal swabs (NPSs) were collected from study participants and were analysed by both AFIAS and RT-PCR assay. A questionnaire collecting demographic and exposure data were administered to all participants. AFIAS accuracy parameters including Cohen's kappa (K) were determined. RESULTS Overall, from November 2020 to April 2021, 1294 (NPSs) were collected from 1183 participants (88.6% males, 11.4% females; mean age were 41.3, median age 42). Forty-nine NPSs (3.78%) were positive by RT-PCR, while 54 NPSs were positive by AFIAS. Overall baseline sensitivity, specificity, positive and negative predictive values were 0.633, 0.981, 0.574, 0.985, respectively and K was 0.585 (moderate). AFIAS sensitivity tended to be higher for NPSs with higher viral load. A higher sensitivity (0.944) compared to the overall baseline sensitivity (0.633) was also found for NPSs from participants with COVID-19 compatible symptoms, for which K was 0.891 (almost perfect). Instead, AFIAS sensitivity was quite poor for NPSs from asymptomatic participants. Most false negative NPSs in this group had moderate viral load. CONCLUSION Overall, AFIAS showed high specificity but only moderate sensitivity, mainly because of the high proportion of asymptomatic participants. However, AFIAS showed good sensitivity for NPSs with high viral load and nearly optimal accuracy parameters for NPSs from participants with COVID-19 compatible symptoms. Thus, taking into consideration its performance features, this test can be useful for COVID-19 case identification and management as well as for infection control.
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Dobrynin D, Polischuk I, Pokroy B. A Comparison Study of the Detection Limit of Omicron SARS-CoV-2 Nucleocapsid by Various Rapid Antigen Tests. BIOSENSORS 2022; 12:1083. [PMID: 36551050 PMCID: PMC9775131 DOI: 10.3390/bios12121083] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 10/25/2022] [Revised: 11/23/2022] [Accepted: 11/24/2022] [Indexed: 06/17/2023]
Abstract
Rapid antigen tests (RATs) are widely used worldwide to detect SARS-CoV-2 since they are an easy-to-use kit and offer rapid results. The RAT detects the presence of the nucleocapsid protein, which is located inside the virus. However, the sensitivity of the different RATs varies between commercially available kits. The test result might change due to various factors, such as the variant type, infection date, swab's surface, the manner in which one performs the testing and the mucus components. Here, we compare the detection limit of seven commercially available RATs by introducing them to known SARS-CoV-2 nucleocapsid protein amounts from the Omicron variant. It allows us to determine the detection limit, disregarding the influences of other factors. A lower detection limit of the RAT is necessary since earlier detection will help reduce the spread of the virus and allow faster treatment, which might be crucial for the population at risk.
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Affiliation(s)
- Daniela Dobrynin
- Department of Materials Science and Engineering, Technion—Israel Institute of Technology, Haifa 32000, Israel
| | - Iryna Polischuk
- Department of Materials Science and Engineering, Technion—Israel Institute of Technology, Haifa 32000, Israel
| | - Boaz Pokroy
- Department of Materials Science and Engineering, Technion—Israel Institute of Technology, Haifa 32000, Israel
- The Russel Berrie Nanotechnology Institute, Technion—Israel Institute of Technology, Haifa 32000, Israel
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Ang GY, Chan KG, Yean CY, Yu CY. Lateral Flow Immunoassays for SARS-CoV-2. Diagnostics (Basel) 2022; 12:2854. [PMID: 36428918 PMCID: PMC9689684 DOI: 10.3390/diagnostics12112854] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/15/2022] [Revised: 11/09/2022] [Accepted: 11/16/2022] [Indexed: 11/19/2022] Open
Abstract
The continued circulation of SARS-CoV-2 virus in different parts of the world opens up the possibility for more virulent variants to evolve even as the coronavirus disease 2019 transitions from pandemic to endemic. Highly transmissible and virulent variants may seed new disruptive epidemic waves that can easily put the healthcare system under tremendous pressure. Despite various nucleic acid-based diagnostic tests that are now commercially available, the wide applications of these tests are largely hampered by specialized equipment requirements that may not be readily available, accessible and affordable in less developed countries or in low resource settings. Hence, the availability of lateral flow immunoassays (LFIs), which can serve as a diagnostic tool by detecting SARS-CoV-2 antigen or as a serological tool by measuring host immune response, is highly appealing. LFI is rapid, low cost, equipment-free, scalable for mass production and ideal for point-of-care settings. In this review, we first summarize the principle and assay format of these LFIs with emphasis on those that were granted emergency use authorization by the US Food and Drug Administration followed by discussion on the specimen type, marker selection and assay performance. We conclude with an overview of challenges and future perspective of LFI applications.
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Affiliation(s)
- Geik Yong Ang
- Faculty of Sports Science and Recreation, Universiti Teknologi MARA, Shah Alam 40450, Malaysia
| | - Kok Gan Chan
- Division of Genetics and Molecular Biology, Institute of Biological Sciences, Faculty of Science, University of Malaya, Kuala Lumpur 50603, Malaysia
- International Genome Centre, Jiangsu University, Zhenjiang 212013, China
| | - Chan Yean Yean
- Department of Medical Microbiology and Parasitology, School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu 16150, Malaysia
| | - Choo Yee Yu
- Laboratory of Vaccine and Biomolecules, Institute of Bioscience, Universiti Putra Malaysia, Serdang 43400, Malaysia
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