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Chen H, Gao Y, Li G, Alam M, Udayakumar S, Mateen QN, Rostamian S, Cilley K, Kim S, Cho G, Gwak J, Song Y, Hardie JM, Kanakasabapathy MK, Kandula H, Thirumalaraju P, Song Y, Parandakh A, Bigdeli A, Fricker GP, Gustafson J, Chung RT, Mera J, Shafiee H. Reducing hepatitis C diagnostic disparities with a fully automated deep learning-enabled microfluidic system for HCV antigen detection. SCIENCE ADVANCES 2025; 11:eadt3803. [PMID: 40106555 PMCID: PMC11922049 DOI: 10.1126/sciadv.adt3803] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 09/24/2024] [Accepted: 02/12/2025] [Indexed: 03/22/2025]
Abstract
Viral hepatitis remains a major global health issue, with chronic hepatitis B (HBV) and hepatitis C (HCV) causing approximately 1 million deaths annually, primarily due to liver cancer and cirrhosis. More than 1.5 million people contract HCV each year, disproportionately affecting vulnerable populations, including American Indians and Alaska Natives (AI/AN). While direct-acting antivirals (DAAs) are highly effective, timely and accurate HCV diagnosis remains a challenge, particularly in resource-limited settings. The current two-step HCV testing process is costly and time-intensive, often leading to patient loss before treatment. Point-of-care (POC) HCV antigen (Ag) testing offers a promising alternative, but no FDA-approved test meets the required sensitivity and specificity. To address this, we developed a fully automated, smartphone-based POC HCV Ag assay using platinum nanoparticles, deep learning image processing, and microfluidics. With an overall accuracy of 94.59%, this cost-effective, portable device has the potential to reduce HCV-related health disparities, particularly among AI/AN populations, improving accessibility and equity in care.
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Affiliation(s)
- Hui Chen
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Yuxin Gao
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Gaojian Li
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Manasvi Alam
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Srisruthi Udayakumar
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Qazi Noorul Mateen
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Sahar Rostamian
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Katherine Cilley
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Sungwan Kim
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Giwon Cho
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Juyong Gwak
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Yixuan Song
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Joseph Michael Hardie
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Manoj Kumar Kanakasabapathy
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Hemanth Kandula
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Prudhvi Thirumalaraju
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Younseong Song
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Azim Parandakh
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Arafeh Bigdeli
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
| | - Gregory P. Fricker
- Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA
| | - Jenna Gustafson
- Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA
| | - Raymond T. Chung
- Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA
| | - Jorge Mera
- Infectious Diseases, Cherokee Nation Health Services, Tahlequah, OK, 74464, USA
| | - Hadi Shafiee
- Division of Engineering in Medicine, Division of Renal Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02139, USA
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Hauner A, Onwuchekwa C, Ariën KK. Sample-to-result molecular diagnostic platforms and their suitability for infectious disease testing in low- and middle-income countries. Expert Rev Mol Diagn 2024; 24:423-438. [PMID: 38747017 DOI: 10.1080/14737159.2024.2353690] [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: 12/08/2023] [Accepted: 05/07/2024] [Indexed: 05/22/2024]
Abstract
INTRODUCTION Diagnostics are an essential, undervalued part of the health-care system. For many diseases, molecular diagnostics are the gold standard, but are not easy to implement in Low- and Middle-Income Countries (LMIC). Sample-to-result (S2R) platforms combining all procedures in a closed system could offer a solution. In this paper, we investigated their suitability for implementation in LMIC. AREAS COVERED A scorecard was used to evaluate different platforms on a range of parameters. Most platforms scored fairly on the platform itself, ease-of-use and test consumables; however, shortcomings were identified in cost, distribution and test panels tailored to LMIC needs. The diagnostic coverage for common infectious diseases was found to have a wider coverage in high-income countries (HIC) than LMIC. A literature study showed that in LMIC, these platforms are mainly used as diagnostic tools or evaluation of diagnostic performance, with a minority assessing the operational characteristics or the clinical utility. In this narrative review, we identified various points for adaptation of S2R platforms to LMIC conditions. EXPERT OPINION For S2R platforms to be suitable for implementation in LMIC some modifications by the manufacturers could be considered. Furthermore, strengthening health systems and digitalization are vital; as are smaller, cheaper, faster, and sustainable technologies.
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Affiliation(s)
- Anne Hauner
- Virology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
| | | | - Kevin K Ariën
- Virology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
- Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium
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Pisa P, Kinge CW, Chasela C, Mothibi E, Thaung YM, Thwin HT, Aung NM, Chew KW, Gandhi MM, Clint C, Minior T, Lwin AA, Freiman MJ, Kyi KP, Sein YY, Marange F, van der Horst C, Mohamed S, Barralon M, Sanne I. Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar. J Clin Virol 2024; 171:105653. [PMID: 38408420 PMCID: PMC11178258 DOI: 10.1016/j.jcv.2024.105653] [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: 07/18/2023] [Revised: 02/06/2024] [Accepted: 02/10/2024] [Indexed: 02/28/2024]
Abstract
BACKGROUND Developing countries experience limited access to HCV laboratory tests for different reasons. Providing near to real-time HCV testing and results especially to at-risk populations including those in rural settings for timely initiation to treatment is key. Within a rural Myanmar setting, we compared HCV diagnostic detection and quantification of the GeneXpert, and Advanced Biological Laboratories UltraGene-HCV assays against the gold standard and reference method Roche real-time HCV in Myanmar. METHODS Blood samples from 158 high-risk individuals were assessed using three different methods at baseline. Results were checked for normality and log transformed. Log differences and bias between methods were calculated and correlated. Pearson's correlation coefficient was used to determine the association of HCV viral loads across all methods. The level of agreement with the standard method (Roche real time HCV) was assessed using Bland-Altman analyses. RESULTS There was a strong positive correlation coefficient between all three methods with GeneXpert and Roche having the strongest, r = 0.96, (p<0.001). Compared to Roche, ABL (mean difference, 95 % limits of agreement; -0.063 and -1.4 to 1.3 Log10IU/mL) and GeneXpert (mean difference, 95 % limits of agreement; -0.28 and -0.7 to 1.8 Log10IU/mL) showed a good level of agreement with the GeneXpert being slightly superior. CONCLUSION We demonstrate the excellent performance and no-inferiority, in terms of levels of agreements of both GeneXpert and ABL compared to the Roche platform and supporting the use of the POC assays as alternative a cost-effective methods in HCV detection and diagnosis in developing and low resource settings countries.
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Affiliation(s)
- Pedro Pisa
- Department of Strategic Information, Right to Care, Centurion, South Africa; Department of Human Nutrition, University of Pretoria, Faculty of Health Sciences, Pretoria, South Africa
| | - Constance Wose Kinge
- Department of Implementation Science, Right to Care, Centurion, South Africa; Department of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
| | - Charles Chasela
- Department of Implementation Science, Right to Care, Centurion, South Africa; Department of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
| | - Eula Mothibi
- Department of Implementation Science, Right to Care, Centurion, South Africa
| | | | - Hnin T Thwin
- Community Partners International, Yangon, Myanmar
| | - Nay M Aung
- Community Partners International, Yangon, Myanmar
| | - Kara W Chew
- David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
| | - Malini M Gandhi
- David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
| | | | | | - Aye A Lwin
- U.S. Agency for International Development, USA
| | - Morgan J Freiman
- Department of Medical Research, Ministry of Health and Sports, Yangon, Myanmar
| | - Khin P Kyi
- Myanmar Liver Foundation, Yangon, Myanmar
| | - Yi Y Sein
- Department of Medical Research, Ministry of Health and Sports, Yangon, Myanmar
| | | | | | - Sofiane Mohamed
- Advanced Biological Laboratories (ABL) SA.17, rue des Jardiniers, Luxembourg 1835
| | - Matthieu Barralon
- Advanced Biological Laboratories (ABL) SA.17, rue des Jardiniers, Luxembourg 1835
| | - Ian Sanne
- Clinical HIV Research Unit, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
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Shivangi, Mishra MK, Gupta S, Razdan K, Sudan S, Sehgal S. Clinical diagnosis of viral hepatitis: Current status and future strategies. Diagn Microbiol Infect Dis 2024; 108:116151. [PMID: 38184983 DOI: 10.1016/j.diagmicrobio.2023.116151] [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: 02/01/2023] [Revised: 08/15/2023] [Accepted: 11/24/2023] [Indexed: 01/09/2024]
Abstract
Viral hepatitis (VH) is a significant public health issue with tremendous potential to aggravate into chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. Recent decade has witnessed remarkable uprising in the drug development and effective treatment of VH. An upsurge is seen in identification of antiviral therapies with low rates of viral resistance, the improvement of Hepatitis B Virus (HBV) vaccination and the development of direct-acting antivirals for Hepatitis C Virus (HCV). But unfortunately, the "2030 worldwide eradication" objective of World Health Organization (WHO) is still unmet. It can be largely attributed to the deficit faced by the healthcare system concerning screening and diagnosis. A timely, accurate and comprehensive screening; encompassing maximum population coverage is essential to combat this disease. However, advancements in VH diagnostics remain inadequate and with a marginal use in routine practice. This paper deliberates upon the lacunae in traditional and prevailing diagnostic methodology of viral hepatitis, especially their inadequacy in meeting the unique situations prevailing low- and middle-income countries (LMIC).
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Affiliation(s)
- Shivangi
- Centre for Molecular Biology, Central University of Jammu, Jammu (J&K), India
| | - Manish Kumar Mishra
- Centre for Molecular Biology, Central University of Jammu, Jammu (J&K), India
| | | | - Konika Razdan
- Government Medical College, Bakshi Nagar, Jammu, Jammu and Kashmir 180001, India
| | - Shashi Sudan
- Government Medical College, Bakshi Nagar, Jammu, Jammu and Kashmir 180001, India
| | - Shelly Sehgal
- Centre for Molecular Biology, Central University of Jammu, Jammu (J&K), India.
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Nhu QBT, Thuy LLT, Nguyen HT, Thanh BN, Rapoud D, Quillet C, Tran HT, Vallo R, Tuyet TNT, Michel L, Weiss L, Perre PV, Hai VV, Nagot N, Hai OKT, Des Jarlais D, Duong HT, Minh KP, Laureillard D, Molès JP. HCV RNA Quantification by a Domestic Commercial Assay: A Case Study among People Who Inject Drugs in Vietnam. Diagnostics (Basel) 2023; 13:3456. [PMID: 37998592 PMCID: PMC10670863 DOI: 10.3390/diagnostics13223456] [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: 10/16/2023] [Revised: 11/07/2023] [Accepted: 11/09/2023] [Indexed: 11/25/2023] Open
Abstract
The desired performance of nucleic acid testing (NAT) may vary if used for disease diagnosis or for the evaluation of the therapeutic efficacy of a treatment, although in most cases, the same assay is used. However, these tests may not be affordable in many situations including in low/middle income countries that in response have developed domestic assays. Given the example of HCV NAT among people who inject drugs in Vietnam, we aimed at evaluating a domestic assay versus an FDA- and CE-approved assay. This cross-evaluation revealed that (i) the domestic assay had a poorer sensitivity with a threshold of detection above 104 IU/mL, and (ii) the FDA-approved assay had a percentage of false negative results close to 1%. Together, in the present study, the domestic assay had a performance compatible with diagnosis purposes (given that this population was 70% HCV seropositive) but not compatible with HCV treatment monitoring (given that treatment failures are rare and the observed viremia frequently below the threshold of detection). This study highlights the need for a proper evaluation of HCV RNA domestic assays in order to efficiently contribute to the WHO HCV elimination target by 2030.
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Affiliation(s)
- Quynh Bach Thi Nhu
- Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam; (Q.B.T.N.); (L.L.T.T.); (H.T.N.); (B.N.T.); (H.T.T.); (H.T.D.); (K.P.M.)
| | - Linh Le Thi Thuy
- Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam; (Q.B.T.N.); (L.L.T.T.); (H.T.N.); (B.N.T.); (H.T.T.); (H.T.D.); (K.P.M.)
| | - Hong Thi Nguyen
- Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam; (Q.B.T.N.); (L.L.T.T.); (H.T.N.); (B.N.T.); (H.T.T.); (H.T.D.); (K.P.M.)
| | - Binh Nguyen Thanh
- Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam; (Q.B.T.N.); (L.L.T.T.); (H.T.N.); (B.N.T.); (H.T.T.); (H.T.D.); (K.P.M.)
| | - Delphine Rapoud
- Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France; (D.R.); (C.Q.); (R.V.); (P.V.P.); (N.N.); (D.L.)
| | - Catherine Quillet
- Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France; (D.R.); (C.Q.); (R.V.); (P.V.P.); (N.N.); (D.L.)
| | - Hong Thi Tran
- Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam; (Q.B.T.N.); (L.L.T.T.); (H.T.N.); (B.N.T.); (H.T.T.); (H.T.D.); (K.P.M.)
| | - Roselyne Vallo
- Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France; (D.R.); (C.Q.); (R.V.); (P.V.P.); (N.N.); (D.L.)
| | - Thanh Nham Thi Tuyet
- Supporting Community Development Initiatives, Hanoi 111000, Vietnam; (T.N.T.T.); (O.K.T.H.)
| | - Laurent Michel
- Inserm UMRS 1018, Pierre Nicole Center, French Red Cross, 75005 Paris, France;
| | - Laurence Weiss
- Université Paris Descartes, Sorbonne Paris Cité, Inserm U976, 75006 Paris, France;
| | - Philippe Vande Perre
- Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France; (D.R.); (C.Q.); (R.V.); (P.V.P.); (N.N.); (D.L.)
| | - Vinh Vu Hai
- Infectious and Tropical Diseases Department, Viet Tiep Hospital, Hai Phong 180000, Vietnam;
| | - Nicolas Nagot
- Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France; (D.R.); (C.Q.); (R.V.); (P.V.P.); (N.N.); (D.L.)
| | - Oanh Khuat Thi Hai
- Supporting Community Development Initiatives, Hanoi 111000, Vietnam; (T.N.T.T.); (O.K.T.H.)
| | - Don Des Jarlais
- School of Global Public Health, New York University, New York, NY 10012, USA;
| | - Huong Thi Duong
- Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam; (Q.B.T.N.); (L.L.T.T.); (H.T.N.); (B.N.T.); (H.T.T.); (H.T.D.); (K.P.M.)
| | - Khue Pham Minh
- Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam; (Q.B.T.N.); (L.L.T.T.); (H.T.N.); (B.N.T.); (H.T.T.); (H.T.D.); (K.P.M.)
| | - Didier Laureillard
- Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France; (D.R.); (C.Q.); (R.V.); (P.V.P.); (N.N.); (D.L.)
- Infectious Diseases Department, Caremeau University Hospital, 30900 Nîmes, France
| | - Jean-Pierre Molès
- Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France; (D.R.); (C.Q.); (R.V.); (P.V.P.); (N.N.); (D.L.)
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Hassan MRA, Chan HK, Nordin M, Yahya R, Sulaiman WRW, Merican SAA, Lah D, Sem X, Shilton S. Assessing feasibility of a modified same-day test-and-treat model for hepatitis C among rural people who inject drugs. Harm Reduct J 2023; 20:48. [PMID: 37046294 PMCID: PMC10091347 DOI: 10.1186/s12954-023-00780-3] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2023] [Accepted: 04/06/2023] [Indexed: 04/14/2023] Open
Abstract
BACKGROUND Despite advancements in hepatitis C virus (HCV) treatment, low uptake among hard-to-reach populations remains a global issue. The current study aimed to assess the feasibility of a modified same-day test-and-treat model in improving HCV care for people who inject drugs (PWID) living in resource-constrained rural areas. METHODS A pilot study was conducted in four primary healthcare (PHC) centers in Malaysia. The model's key features included on-site HCV ribonucleic acid (RNA) testing using a shared GeneXpert® system; noninvasive biomarkers for cirrhosis diagnosis; and extended care to PWID referred from nearby PHC centers and outreach programs. The feasibility assessment focused on three aspects of the model: demand (i.e., uptake of HCV RNA testing and treatment), implementation (i.e., achievement of each step in the HCV care cascade), and practicality (i.e., ability to identify PWID with HCV and expedite treatment initiation despite resource constraints). RESULTS A total of 199 anti-HCV-positive PWID were recruited. They demonstrated high demand for HCV care, with a 100% uptake of HCV RNA testing and 97.4% uptake of direct-acting antiviral treatment. The rates of HCV RNA positivity (78.4%) and sustained virologic response (92.2%) were comparable to standard practice, indicating the successful implementation of the model. The model was also practical, as it covered non-opioid-substitution-therapy-receiving individuals and enabled same-day treatment in 71.1% of the participants. CONCLUSIONS The modified same-day test-and-treat model is feasible in improving HCV care for rural PWID. The study finding suggests its potential for wider adoption in HCV care for hard-to-reach populations.
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Affiliation(s)
| | - Huan-Keat Chan
- Clinical Research Center, Sultanah Bahiyah Hospital, 05460, Alor Setar, Kedah, Malaysia.
| | - Mahani Nordin
- Public Health Division, State Health Department, Alor Setar, Kedah, Malaysia
| | | | | | | | - Darisah Lah
- Bukit Tunggal Health Clinic, Kuala Nerus, Terengganu, Malaysia
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Nyein PP, Tillakeratne S, Phyu S, Yee MM, Lwin MM, Htike KL, Aung MT, Grebely J, Applegate T, Hanson J, Matthews G, Lin KS. Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-Infected Patients in Myanmar. Viruses 2023; 15:v15020521. [PMID: 36851736 PMCID: PMC9967037 DOI: 10.3390/v15020521] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2022] [Revised: 02/06/2023] [Accepted: 02/08/2023] [Indexed: 02/16/2023] Open
Abstract
To evaluate a decentralised testing model and simplified treatment protocol of hepatitis C virus (HCV) infection to facilitate treatment scale-up in Myanmar, this prospective, observational study recruited HIV-HCV co-infected outpatients receiving sofosbuvir/daclatasvir in Yangon, Myanmar. The study examined the outcomes and factors associated with a sustained virological response (SVR). A decentralised "hub-and-spoke" testing model was evaluated where fingerstick capillary specimens were transported by taxi and processed centrally. The performance of the Xpert HCV VL Fingerstick Assay in detecting HCV RNA was compared to the local standard of care ( plasma HCV RNA collected by venepuncture). Between January 2019 and February 2020, 162 HCV RNA-positive individuals were identified; 154/162 (95%) initiated treatment, and 128/154 (84%) returned for their SVR12 visit. A SVR was achieved in 119/154 (77%) participants in the intent-to-treat population and 119/128 (93%) participants in the modified-intent-to-treat population. Individuals receiving an antiretroviral therapy were more likely to achieve a SVR (with an odds ratio (OR) of 7.16, 95% CI 1.03-49.50), while those with cirrhosis were less likely (OR: 0.26, 95% CI 0.07-0.88). The sensitivity of the Xpert HCV VL Fingerstick Assay was 99.4% (95% CI 96.7-100.0), and the specificity was 99.2% (95% CI 95.9-99.9). A simplified treatment protocol using a hub-and-spoke testing model of fingerstick capillary specimens can achieve an SVR rate in LMIC comparable to well-resourced high-income settings.
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Affiliation(s)
| | - Shane Tillakeratne
- The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia
- Correspondence:
| | - Sabai Phyu
- Department of Tropical and Infectious Diseases, Specialist Hospital Waibargi, Yangon W5C4+6J7, Myanmar
| | | | - Mya Mya Lwin
- Department of Microbiology, University of Medicine 2, Yangon 644-704, Myanmar
| | - Kyaw Linn Htike
- Myanmar-Australia Research Collaboration for Health Laboratory, Yangon W5C4+6J7, Myanmar
| | - May Thu Aung
- Myanmar-Australia Research Collaboration for Health Laboratory, Yangon W5C4+6J7, Myanmar
| | - Jason Grebely
- The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia
| | - Tanya Applegate
- The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia
| | - Josh Hanson
- The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia
- Cairns and Hinterland Hospital and Health Service, Cairns North, QLD 4870, Australia
| | - Gail Matthews
- The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia
| | - Kyaw Swar Lin
- Specialist Hospital Mingaladon, Yangon X42H+J4, Myanmar
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Tang W, Tao Y, Fajardo E, Reipold EI, Chou R, Tucker JD, Easterbrook P. Diagnostic Accuracy of Point-of-Care HCV Viral Load Assays for HCV Diagnosis: A Systematic Review and Meta-Analysis. Diagnostics (Basel) 2022; 12:1255. [PMID: 35626411 PMCID: PMC9141110 DOI: 10.3390/diagnostics12051255] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/07/2022] [Revised: 05/05/2022] [Accepted: 05/16/2022] [Indexed: 01/13/2023] Open
Abstract
Despite the widespread availability of curative treatment with direct-acting antivirals, a significant proportion of people with HCV remain undiagnosed and untreated. New point-of-care (PoC) HCV RNA assays that can be used in clinical settings may help expand access to testing and treatment. This study aimed to evaluate the diagnostic performance of PoC HCV viral load assays compared to laboratory-based testing. Methods: We searched three databases for studies published before May 2021 that evaluated PoC HCV RNA assays against a laboratory NAT reference standard (Prospero CRD42021269022). Random effects bivariate models were used to summarize the estimates. Stratified analyses were performed based on geographic region, population (PWID, etc.), and specimen type (serum/plasma or fingerstick; fresh or frozen). We used the GRADE approach to assess the certainty of the evidence. Results: A total of 25 studies were eligible. We evaluated five different commercially available viral load assays. The pooled sensitivity and specificity were 99% (95% CI: 98−99%) and 99% (95% CI: 99−100%), respectively. High sensitivity and specificity were observed across different assays, study settings (including LMICs and HICs), and populations. There was a small but statistically significant reduction in sensitivity for fingersticks compared to serum or plasma samples (98% vs. 100%, p < 0.05), but the specificity was similar between frozen and fresh samples. The evidence was rated as moderate-high certainty. Conclusions: PoC HCV viral load assays demonstrate excellent diagnostic performance in various settings and populations. The WHO now recommends using PoC HCV viral load assays as an additional strategy to promote access to confirmatory viral load testing and treatment.
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Affiliation(s)
- Weiming Tang
- University of North Carolina Project-China, Guangzhou 510095, China; (Y.T.); (J.D.T.)
- Institute for Global Health and Infectious Diseases, University of North Carolina at Chaple Hill, Chapel Hill, NC 27599, USA
| | - Yusha Tao
- University of North Carolina Project-China, Guangzhou 510095, China; (Y.T.); (J.D.T.)
- Institute for Global Health and Infectious Diseases, University of North Carolina at Chaple Hill, Chapel Hill, NC 27599, USA
| | - Emmanuel Fajardo
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, 1211 Geneva, Switzerland; (E.F.); (P.E.)
| | | | - Roger Chou
- Departments of Medicine, Oregon Health & Science University, Portland, OR 97239, USA;
| | - Joseph D. Tucker
- University of North Carolina Project-China, Guangzhou 510095, China; (Y.T.); (J.D.T.)
- Institute for Global Health and Infectious Diseases, University of North Carolina at Chaple Hill, Chapel Hill, NC 27599, USA
| | - Philippa Easterbrook
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, 1211 Geneva, Switzerland; (E.F.); (P.E.)
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9
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Draper BL, Yee WL, Shilton S, Bowring A, Htay H, Nwe N, Markby J, Kyi KP, Easterbrook P, Naing W, Win TM, Aung KS, Howell J, Pedrana A, Hellard M. Feasibility of decentralised, task-shifted hepatitis C testing and treatment services in urban Myanmar: implications for scale-up. BMJ Open 2022; 12:e059639. [PMID: 35504640 PMCID: PMC9066562 DOI: 10.1136/bmjopen-2021-059639] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/13/2023] Open
Abstract
OBJECTIVES To assess the feasibility considerations for a decentralised, one-stop-shop model of care implemented in Yangon, Myanmar. SETTING Two primary care level clinics in urban Yangon, Myanmar. DESIGN This is a feasibility study of a highly effective care model. Using Intervention Complexity Framework by Gericke et al, we collated and analysed programmatic data and evaluation data to outline key project implementation requirements and experiences. PARTICIPANTS Programmatic data were collected from clinical records, GeneXpert device test and maintenance reports, national guidelines, product and device instructions and site monitoring visit reports. Healthcare providers involved in delivering care model contributed interview data. RESULTS The main feasibility considerations are appropriate storage for test kits and treatments (in response to temperature and humidity requirements), installation of a continuous stable electricity supply for the GeneXpert device, air-conditioning for the laboratory room hosting GeneXpert, access to a laboratory for pretreatment assessments and clear referral pathways for specialist consultation when required. Lessons from our project implementation experiences included the extensive time requirements for patient education, the importance of regular error monitoring and stock storage reviews and that flexible appointment scheduling and robust reminder system likely contributed to high retention in care. CONCLUSIONS Detailed documentation and dissemination of feasibility requirements and implementation considerations is vital to assist others to successfully implement a similar model of care elsewhere. We provide 10 recommendations for successful implementation. TRIAL REGISTRATION NUMBER The trial was registered at ClinicalTrials.gov NCT03939013 on May 6, 2019. This manuscript presents post-results data on feasibility.
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Affiliation(s)
- Bridget Louise Draper
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
- School of Public Health and Preventive Medicine, Monash University, St Kilda, Victoria, Australia
| | - Win Lei Yee
- Disease Elimination, Burnet Institute Myanmar, Yangon, Myanmar
| | | | - Anna Bowring
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
| | - Hla Htay
- Disease Elimination, Burnet Institute Myanmar, Yangon, Myanmar
| | | | | | | | - Philippa Easterbrook
- Department of Global HIV, Hepatitis, and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Win Naing
- Myanmar Liver Foundation, Yangon, Myanmar
- Yangon Specialty Hospital, Yangon, Myanmar
| | - Thin Mar Win
- Disease Elimination, Burnet Institute Myanmar, Yangon, Myanmar
| | - Khin Sanda Aung
- National Hepatitis Control Program, Department of Public Health, Ministry of Health and Sports, Yangon, Myanmar
| | - Jessica Howell
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
- St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
| | - Alisa Pedrana
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
- School of Public Health and Preventive Medicine, Monash University, St Kilda, Victoria, Australia
- Health Services Research and Implementation, Monash Partners, Melbourne, Victoria, Australia
| | - Margaret Hellard
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
- School of Public Health and Preventive Medicine, Monash University, St Kilda, Victoria, Australia
- Hepatitis Services, Department of Infectious Diseases, Alfred Hospital, Melbourne, Victoria, Australia
- Doherty Institute, Melbourne, Victoria, Australia
- School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia
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10
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Shilton S, Markby J, Japaridze M, Chihota V, Shadaker S, Gvinjilia L, Tsereteli M, Alkhazashvili M, Butsashvili M, Stvilia K, Ruiz RJ, Asatiani A, Adamia E, Easterbrook P, Khonelidze I, Gamkrelidze A. Feasibility and effectiveness of HCV viraemia testing at harm reduction sites in Georgia: A prospective three-arm study. Liver Int 2022; 42:775-786. [PMID: 35129278 PMCID: PMC9306782 DOI: 10.1111/liv.15191] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/26/2021] [Revised: 12/03/2021] [Accepted: 01/25/2022] [Indexed: 01/15/2023]
Abstract
BACKGROUND AND AIMS In 2015, Georgia began a hepatitis C virus (HCV) elimination programme. Although screening programmes have been decentralized for high-risk groups, viraemic testing remains a bottleneck for people who inject drugs. Here, we describe two models of viraemic testing that aimed to address this gap. METHODS We assigned eight harm reduction sites (HRS) to one of three arms (2,1:1): Xpert HCV viral load testing on-site, blood draw on-site with centralized HCV core antigen testing (HCVcAg), or standard-of-care (SOC) referral with viremia testing performed at treatment centres. RESULTS 1671 HCV-seropositive participants were enrolled (Xpert, 37.1%; HCVcAg, 29.1%; referral, 33.8%). Participants were predominantly male (95.4%), mean age (IQR) 43 (37, 50) years and 1290 (77.2%) were currently injecting drugs. Significantly higher proportions of participants in the Xpert (100%) and HCVcAg (99.8%) arms received viraemia testing compared with the referral arm (91.3%) (Xpert vs referral, p < 0.0001; HCVcAg vs referral, p < 0.0001). Among viraemic participants, treatment uptake was similar (Xpert, 84.0%; HCVcAg, 79.5%; referral, 88.4%). The time between screening and sample collection for viraemia testing was significantly longer in the referral arm compared with both Xpert and HCVcAg arms (median 1 day compared with 0 days respectively), and the overall time between screening to treatment initiation was longer for the referral arm (median 67 days) compared with both Xpert and HCVcAg arms (median 57 and 50 days respectively). CONCLUSIONS Point-of-care viraemia testing and blood drawn on-site for HCVcAg testing yielded more HCV-seropositive patients receiving viraemic testing within a shorter timeframe compared with referrals.
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Affiliation(s)
| | - Jessica Markby
- Foundation for Innovative New DiagnosticsGenevaSwitzerland
| | - Maia Japaridze
- Foundation for Innovative New DiagnosticsGenevaSwitzerland
| | - Violet Chihota
- Foundation for Innovative New DiagnosticsGenevaSwitzerland,Present address:
Aurum InstituteParktownSouth Africa,Present address:
School of Public HealthUniversity of WitwatersrandJohannesburgSouth Africa
| | - Shaun Shadaker
- US Centers for Disease Control and PreventionAtlantaGeorgiaUSA
| | - Lia Gvinjilia
- Training Programs in Epidemiology and Public Health Interventions NetworkDecaturGeorgiaUSA
| | - Maia Tsereteli
- National Center for Disease Control and Public HealthTbilisiGeorgia
| | | | | | - Ketevan Stvilia
- National Center for Disease Control and Public HealthTbilisiGeorgia
| | - Ryan Jose Ruiz
- Foundation for Innovative New DiagnosticsGenevaSwitzerland
| | | | - Ekaterine Adamia
- Ministry of Health, Labour and Social Affairs of GeorgiaTbilisiGeorgia
| | - Philippa Easterbrook
- Department of Global HIV, Hepatitis and STI ProgrammesWorld Health OrganizationGenevaSwitzerland
| | - Irma Khonelidze
- National Center for Disease Control and Public HealthTbilisiGeorgia
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11
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Markby J, Gupta E, Soni D, Sarin S, Murya M, Katapur P, Tewatia N, Ramachandran BE, Ruiz RJ, Gaeddert M, Tyshkovskiy A, Adee M, Chhatwal J, Miglani S, Easterbrook P, Sarin SK, Shilton S. Feasibility, effectiveness and cost of a decentralized HCV care model among the general population in Delhi, India. Liver Int 2022; 42:532-540. [PMID: 34817928 PMCID: PMC9299915 DOI: 10.1111/liv.15112] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/07/2021] [Revised: 11/17/2021] [Accepted: 11/21/2021] [Indexed: 01/05/2023]
Abstract
BACKGROUND AND AIMS India has a significant burden of hepatitis C virus (HCV) infection and has committed to achieving national elimination by 2030. This will require a substantial scale-up in testing and treatment. The "HEAD-Start Project Delhi" aimed to enhance HCV diagnosis and treatment pathways among the general population. METHODS A prospective study was conducted at 5 district hospitals (Arm 1: one-stop shop), 15 polyclinics (Arm 2: referral for viral load (VL) testing and treatment) and 62 screening camps (Arm 3: referral for treatment). HCV prevalence, retention in the HCV care cascade, and turn-around time were measured. RESULTS Between January and September 2019, 37 425 participants were screened for HCV. The median (IQR) age of participants was 35 (26-48) years, with 50.4% male and 49.6% female. A significantly higher proportion of participants in Arm 1 (93.7%) and Arm 3 (90.3%) received a VL test compared with Arm 2 (52.5%, P < .001). Of those confirmed positive, treatment was initiated at significantly higher rates for participants in both Arms 1 (85.6%) and 2 (73.7%) compared to Arm 3 (41.8%, P < .001). Arm 1 was found to be a cost-saving strategy compared to Arm 2, Arm 3, and no action. CONCLUSIONS Delivery of all services at a single site (district hospitals) resulted in a higher yield of HCV seropositive cases and retention compared with sites where participants were referred elsewhere for VL testing and/or treatment. The highest level of retention in the care cascade was also associated with the shortest turn-around times.
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Affiliation(s)
| | - Ekta Gupta
- The Institute of Liver and Biliary SciencesNew DelhiIndia
| | | | | | | | | | | | | | | | - Mary Gaeddert
- Division of Infectious Disease and Tropical MedicineUniversity Hospital HeidelbergHeidelbergGermany
| | - Alexander Tyshkovskiy
- Belozersky Institute of Physico‐Chemical BiologyMoscow State UniversityMoscowRussia,Division of Genetics, Department of MedicineBrigham and Women’s Hospital, Harvard Medical SchoolBostonMassachusettsUSA
| | - Madeline Adee
- Institute for Technology AssessmentMassachusetts General Hospital, Harvard Medical SchoolBostonMassachusettsUSA
| | - Jagpreet Chhatwal
- Institute for Technology AssessmentMassachusetts General Hospital, Harvard Medical SchoolBostonMassachusettsUSA
| | - Sundeep Miglani
- Directorate General of Health ServicesGovernment NCT of DelhiNew DelhiIndia
| | - Philippa Easterbrook
- Department of Global HIV, Hepatitis and STI Programmes GenevaWorld Health OrganizationGenevaSwitzerland
| | - Shiv K. Sarin
- The Institute of Liver and Biliary SciencesNew DelhiIndia
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12
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Thedja MD, Wibowo DP, El-Khobar KE, Ie SI, Setiawan L, Murti IS, Muljono DH. Improving Linkage to Care of Hepatitis C: Clinical Validation of GeneXpert® HCV Viral Load Point-of-Care Assay in Indonesia. Am J Trop Med Hyg 2021; 105:117-124. [PMID: 33999849 PMCID: PMC8274760 DOI: 10.4269/ajtmh.20-1588] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2020] [Accepted: 03/09/2021] [Indexed: 01/07/2023] Open
Abstract
Hepatitis C virus (HCV) infection large-scale diagnosis and treatment are hampered by lack of a simple, rapid, and reliable point-of-care (POC) test, which poses a challenge for the elimination of hepatitis C as a public health problem. This study aimed to evaluate Cepheid Xpert® HCV Viral Load performance in comparison with the Roche Cobas® TaqMan® HCV Test using serum samples of HCV-infected patients in Indonesia. Viral load quantification was performed on 243 anti-HCV positive patients’ samples using both Xpert HCV VL and Roche HCV tests, followed by HCV genotyping by reverse hybridization. Strength of the relationship between the assays was measured by Pearson correlation coefficient, while level of agreement was analyzed by Deming regression and Bland–Altman plot analysis using log10-transformed viral load values. Quantifiable viral load was detected in 180/243 (74.1%), with Xpert HCV VL sensitivity of 100% (95% CI 0.98, 1.00) and specificity of 98.4% (95% CI 0.91, 0.99) based on the Roche HCV test, while HCV genotypes were determined in 172/180 (95.6%) samples. There was a good correlation between both assays (r = 0.97, P < 0.001), overall and per genotype, with good concordance by Deming regression and a mean difference of −0.25 log10 IU/mL (95% CI −0.33, −0.18) by Bland–Altman plot analysis. Xpert HCV VL test was demonstrated as a POC platform with good performance for HCV diagnosis and treatment decision that would be beneficial for decentralized services in resource-limited areas. HCV testing sites, alongside additional GeneXpert modular systems distributed toward the fight against COVID-19, could ensure some continuity, once this pandemic is controlled.
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Affiliation(s)
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- 1Eijkman Institute for Molecular Biology, Jakarta, Indonesia.,2Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia
| | - Lyana Setiawan
- 3Virology Laboratory, Dharmais National Cancer Hospital, Jakarta, Indonesia
| | - Ignatia Sinta Murti
- 4Division of Gastroenterology, Department of Internal Medicine, Abdoel Wahab Sjahranie Regional General Hospital, Samarinda, Indonesia
| | - David Handojo Muljono
- 1Eijkman Institute for Molecular Biology, Jakarta, Indonesia.,2Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.,5Faculty of Medicine and Health, University of Sydney, New South Wales, Australia
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13
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Muhamad NA, Ab Ghani RM, Abdul Mutalip MH, Muhammad EN, Mohamad Haris H, Mohd Zain R, Abdullah N, Muhammad Azami NA, Abd Jalal N, Ismail N, Mhd Yusuf NA, Othman R, Kamalul Arifin AS, Abdullah MS, Kamaruddin MA, Abu Hassan MR, Aris T, Jamal R. Seroprevalence of hepatitis B virus and hepatitis C virus infection among Malaysian population. Sci Rep 2020; 10:21009. [PMID: 33273475 PMCID: PMC7713078 DOI: 10.1038/s41598-020-77813-5] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2020] [Accepted: 10/21/2020] [Indexed: 11/25/2022] Open
Abstract
Malaysia is a country with an intermediate endemicity for hepatitis B. As the country moves toward hepatitis B and C elimination, population-based estimates are necessary to understand the burden of hepatitis B and C for evidence-based policy-making. Hence, this study aims to estimate the prevalence of hepatitis B and C in Malaysia. A total of 1458 participants were randomly selected from The Malaysian Cohort (TMC) aged 35 to 70 years between 2006 and 2012. All blood samples were tested for hepatitis B and C markers including hepatitis B surface antigen (HBsAg), anti-hepatitis B core antibody (anti-HBc), antibodies against hepatitis C virus (anti-HCV). Those reactive for hepatitis C were further tested for HCV RNA genotyping. The sociodemographic characteristics and comorbidities were used to evaluate their associated risk factors. Descriptive analysis and multivariable analysis were done using Stata 14. From the samples tested, 4% were positive for HBsAg (95% CI 2.7-4.7), 20% were positive for anti-HBc (95% CI 17.6-21.9) and 0.3% were positive for anti-HCV (95% CI 0.1-0.7). Two of the five participants who were reactive for anti-HCV had the HCV genotype 1a and 3a. The seroprevalence of HBV and HCV infection in Malaysia is low and intermediate, respectively. This population-based study could facilitate the planning and evaluation of the hepatitis B and C control program in Malaysia.
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Affiliation(s)
- Nor Asiah Muhamad
- Evidence-Based Healthcare Sector, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
- Center for Communicable Diseases Epidemiology Research, Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
| | - Rimah Melati Ab Ghani
- Evidence-Based Healthcare Sector, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
- Center for Communicable Diseases Epidemiology Research, Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
| | - Mohd Hatta Abdul Mutalip
- Center for Communicable Diseases Epidemiology Research, Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
| | - Eida Nurhadzira Muhammad
- Center for Communicable Diseases Epidemiology Research, Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
| | - Hasmah Mohamad Haris
- Center for Communicable Diseases Epidemiology Research, Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
| | - Rozainanee Mohd Zain
- Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
| | - Noraidatulakma Abdullah
- UKM Medical Molecular Biology Institute (UMBI), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Nor Azila Muhammad Azami
- UKM Medical Molecular Biology Institute (UMBI), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Nazihah Abd Jalal
- UKM Medical Molecular Biology Institute (UMBI), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Norliza Ismail
- UKM Medical Molecular Biology Institute (UMBI), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Nurul Ain Mhd Yusuf
- UKM Medical Molecular Biology Institute (UMBI), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Raihannah Othman
- UKM Medical Molecular Biology Institute (UMBI), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | | | - Mohd Shaharom Abdullah
- UKM Medical Molecular Biology Institute (UMBI), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | - Mohd Arman Kamaruddin
- UKM Medical Molecular Biology Institute (UMBI), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
| | | | - Tahir Aris
- Center for Communicable Diseases Epidemiology Research, Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
- Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, 40170, Shah Alam, Malaysia
| | - Rahman Jamal
- UKM Medical Molecular Biology Institute (UMBI), Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
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14
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Evaluación de la precisión diagnóstica del sistema Cobas 6800 para la detección de los niveles de viremia del virus de la hepatitis C a partir de muestras de gotas de sangre seca en papel de filtro. Enferm Infecc Microbiol Clin 2020; 38:267-274. [DOI: 10.1016/j.eimc.2019.10.009] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2019] [Revised: 10/01/2019] [Accepted: 10/03/2019] [Indexed: 01/22/2023]
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15
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Shiha G, Soliman R, Serwah A, Mikhail NNH, Asselah T, Easterbrook P. A same day 'test and treat' model for chronic HCV and HBV infection: Results from two community-based pilot studies in Egypt. J Viral Hepat 2020; 27:593-601. [PMID: 31999866 DOI: 10.1111/jvh.13268] [Citation(s) in RCA: 25] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/20/2019] [Revised: 11/13/2019] [Accepted: 01/05/2020] [Indexed: 01/20/2023]
Abstract
Prompt access to confirmatory viral load testing and staging of liver disease are key barriers in uptake of treatment for chronic hepatitis B and C infection. Our objective was to establish the feasibility of a same day 'test and treat' model in two distinct community-based settings in Egypt through use of key point-of-care (POC) portable tools for HCV and HBV viral load assessment and staging of liver disease followed by treatment initiation. Community sites were a village in northern Egypt (site 1) and a government office in Cairo (site 2). The following model was adopted: community awareness raising in the week before project initiation; site assessment to ensure optimal placement and calibration of equipment and clinical care set-up; transfer of key portable laboratory instruments to the sites (four cartridge GeneXpert, FibroScan and abdominal ultrasound); screening using rapid diagnostic tests for HCV-Ab and HBsAg, with immediate venous or finger-stick blood sampling for HCV-RNA and HBV-DNA assay, FibroScan staging of liver disease and ultrasound screening for liver cancer. At site 1, 475 individuals were screened over a single day, 125 were positive for HCV-Ab and 4 for HBsAg, 43 of 56 new HCV diagnoses were HCV RNA positive, and 3 of 4 HBsAg positive were HBV DNA positive, 40 initiated HCV treatment, and one HBV treatment . At site 2, 3188 individuals were screened over 3 days, 157 were positive for HCV-Ab, and 27 for HBsAg; 38 of 76 new HCV diagnoses were HCV RNA positive, and 15 of 18 HBsAg positive were HBV-DNA positive. Across both sites, 78 patients were counselled and initiated on treatment for HCV and 12 for HBV within 3 and 4 hours, respectively, of initial positive rapid diagnostic test result. We have shown the feasibility of a same day 'test and treat' model for chronic HCV and HBV infection in two community-based settings in Egypt that achieved high levels of linkage to care and initial treatment.
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Affiliation(s)
- Gamal Shiha
- Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt
- Hepatology and Gastroenterology Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Reham Soliman
- Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt
- Tropical Medicine Department, Faculty of Medicine, Port Said University, Port Said, Egypt
| | - Abdalhamed Serwah
- Internal Medicine Department, Faculty of Medicine, Suez Canal University (SCU), Ismailia, Egypt
| | - Nabiel N H Mikhail
- Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt
- Department of Biostatistics and Cancer Epidemiology, South Egypt Cancer Institute, Assiut University, Asyut, Egypt
| | - Tarik Asselah
- INSERM UMR1149, Hepatology, Hospital Beaujon, Centre de Recherche sur l'Inflammation (CRI), University Paris Diderot, Clichy, France
| | - Philippa Easterbrook
- Global Hepatitis Programme, Department of HIV, Hepatitis and STIs (HHS), World Health Organization, Geneva, Switzerland
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16
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Tran TH, Nguyen BT, Nguyen TA, Pham TTP, Nguyen TTT, Mai HTB, Pham HB, Nguyen TM, Phan HTT, Do NT, Ait-Ahmed M, Taieb F, Madec Y. Dried blood spots perform well to identify patients with active HCV infection in Vietnam. J Viral Hepat 2020; 27:514-519. [PMID: 31981287 DOI: 10.1111/jvh.13263] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/14/2019] [Revised: 12/20/2019] [Accepted: 01/06/2020] [Indexed: 12/26/2022]
Abstract
Recently, treatment advances in direct-acting antivirals have radically changed the management of HCV patients. However, in resource-limited countries, identification of patients with active HCV infection is still challenging in remote settings due to the limited access to laboratories able to measure HCV viral load. This study evaluated whether dried blood spots (DBS) transferred to a central laboratory could overcome this challenge. A total of 315 HCV-infected patients, naïve to anti-HCV treatment, provided each three type of samples: plasma, DBS with calibrated quantities of venous blood and DBS with uncalibrated quantities of capillary blood. Qualitative comparison was conducted in terms of detection of HCV viral load on DBS as opposed to plasma to estimate sensitivity and specificity. Quantitative comparisons were conducted by means of correlation estimation. Of the 250 patients with detected plasma HCV viral load, 245 also had detectable DBS HCV viral load (capillary or venous) leading to a sensitivity of 98.0% (95% confidence interval (CI): 95.4%-99.3%); importantly, all measurements with a plasma HCV viral load >118 IU/mL were also detected in DBS. When HCV was not detected in plasma, it was also not detected in DBS resulting in 100% specificity (95% CI: 94.5%-100%). Quantitative HCV viral load results were very similar when utilizing plasma or DBS sample types as illustrated by correlations >0.99. In conclusion, DBS sample types, with either uncalibrated capillary blood or calibrated venous blood, performed well to distinguish patients with active HCV infection, and who therefore need treatment, from other patients.
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Affiliation(s)
- Tram Hong Tran
- National Reference Laboratory of HIV Molecular Biology, National Institute of Hygiene and Epidemiology, Hanoi, Vietnam
| | - Binh Thanh Nguyen
- National Reference Laboratory of HIV Molecular Biology, National Institute of Hygiene and Epidemiology, Hanoi, Vietnam
| | - Tuan Anh Nguyen
- National Reference Laboratory of HIV Molecular Biology, National Institute of Hygiene and Epidemiology, Hanoi, Vietnam
| | - Tram Thi Phuong Pham
- National Reference Laboratory of HIV Molecular Biology, National Institute of Hygiene and Epidemiology, Hanoi, Vietnam
| | | | | | | | | | - Huong Thi Thu Phan
- Vietnam Administration of HIV/AIDS Control, Ministry of Health, Hanoi, Vietnam
| | - Nhan Thi Do
- Vietnam Administration of HIV/AIDS Control, Ministry of Health, Hanoi, Vietnam
| | - Mohand Ait-Ahmed
- Center for Translational Research, Institut Pasteur, Paris, France
| | - Fabien Taieb
- Center for Translational Research, Institut Pasteur, Paris, France.,Emerging Diseases Epidemiology Unit, Institut Pasteur, Paris, France
| | - Yoann Madec
- Emerging Diseases Epidemiology Unit, Institut Pasteur, Paris, France
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17
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Risk of liver fibrosis progression in patients with suboptimal diagnosis of hepatitis C virus infection. Eur J Gastroenterol Hepatol 2020; 32:528-534. [PMID: 31490420 DOI: 10.1097/meg.0000000000001534] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
OBJECTIVE Many hepatitis C virus (HCV)-infected patients have a suboptimal diagnosis. Particularly, the characteristics and risk of fibrosis progression of HCV antibody-positive patients without RNA testing are unknown. METHODS Patients with a positive HCV antibody performed during 2005-2007 were classified based on RNA request and result until January 2017. Fibrosis was estimated with serologic scores. RESULTS Of the 38 246 HCV tests performed, 791 (2.01%) patients tested positive. At the end of the follow-up (median 128.6 months, range 109.8-145.9), 49.43% (n = 391) of the subjects did not have RNA testing, 13.02% (n = 103) had undetectable RNA, and 37.55% (n = 297) had detectable RNA. After excluding patients without data for AST to platelet ratio index calculation (n = 334), patients without RNA testing (n = 122) compared with RNA undetectable (n = 92) were more frequently men (68.9 versus 46.7%), alcohol (52.6 versus 38.2%) and drug (53.0 versus 39.1%) users, lacking social support (50.4 versus 29.3%), and showed higher basal fibrosis. Patients without RNA testing had a significantly higher increase in the percentage of patients with ≥F2 (P = 0.035) and cirrhosis (P = 0.022). The relative risk for ≥F2 and cirrhosis in patients without RNA testing was 3.03 [95% confidence interval (CI): 1.54-5.98] and 4.31 (95% CI: 1.42-13.10), respectively. Non-RNA request was an independent predictor factor for progression to cirrhosis. CONCLUSION In our cohort, patients with positive HCV antibody without RNA testing were more likely to be people at risk of social exclusion with an increased risk of fibrosis progression, because non-RNA request was a predictor for cirrhosis. Therefore, we urge support measures and strategies to link to care these difficult-to-treat populations.
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Mohamed Z, Mbwambo J, Rwegasha J, Mgina N, Doulla B, Mwakale P, Tuaillon E, Chevaliez S, Shimakawa Y, Taylor‐Robinson SD, Thursz MR, Brown AS, Lemoine M. In-field evaluation of Xpert® HCV viral load Fingerstick assay in people who inject drugs in Tanzania. Liver Int 2020; 40:514-521. [PMID: 31778282 PMCID: PMC7079170 DOI: 10.1111/liv.14315] [Citation(s) in RCA: 22] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/11/2019] [Revised: 11/06/2019] [Accepted: 11/15/2019] [Indexed: 12/17/2022]
Abstract
BACKGROUND Although novel hepatitis C virus (HCV) RNA point-of-care technology has the potential to enhance the diagnosis in resource-limited settings, very little real-world validation of their utility exists. We evaluate the performance of HCV RNA quantification using the Xpert® HCV viral load Fingerstick assay (Xpert® HCV VL Fingerstick assay) as compared to the World Health Organisation pre-qualified plasma Xpert® HCV VL assay among people who inject drugs (PWID) attending an opioid agonist therapy (OAT) clinic in Dar-es-Salaam, Tanzania. METHODS Between December 2018 and February 2019, consecutive HCV seropositive PWID attending the OAT clinic provided paired venous and Fingerstick samples for HCV RNA quantification. These were processed onsite using the GeneXpert® platform located at the Central tuberculosis reference laboratory. RESULTS A total of 208 out of 220 anti-HCV-positive participants recruited (94.5%) had a valid Xpert® HCV VL result available; 126 (61%; 95% CI 53.8-67.0) had detectable and quantifiable HCV RNA. About 188 (85%) participants had paired plasma and Fingerstick whole blood samples; the sensitivity and specificity for the quantification of HCV RNA levels were 99.1% and 98.7% respectively. There was an excellent correlation (R2 = .95) and concordance (mean difference 0.13 IU/mL, (95% CI -0.9 to 0.16 IU/mL) in HCV RNA levels between plasma samples and Fingerstick samples. CONCLUSION This study found excellent performance of the Xpert® HCV VL Fingerstick assay for HCV RNA detection and quantification in an African-field setting. Its clinical utility represents an important watershed in overcoming existing challenges to HCV diagnosis, which should play a crucial role in HCV elimination in Africa.
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Affiliation(s)
- Zameer Mohamed
- Department of HepatologyImperial College LondonSt Mary's HospitalLondonUK
| | - Jessie Mbwambo
- Department of PsychiatryMuhimbili National HospitalMuhimbili University of Health and Allied SciencesDar es SalaamTanzania
| | - John Rwegasha
- Department of GastroenterologyMuhimbili National HospitalDar es SalaamTanzania
| | - Nicodem Mgina
- Tanzania Central Tuberculosis Reference LaboratoryMuhimbili National HospitalDar es SalaamTanzania
| | - Basra Doulla
- Tanzania Central Tuberculosis Reference LaboratoryMuhimbili National HospitalDar es SalaamTanzania
| | - Promise Mwakale
- Department of BioethicsMuhimbili University of Health and Allied SciencesDar es SalaamTanzania
| | - Edouard Tuaillon
- INSERM U 1058Université Montpellier 1MontpellierFrance
- Département de Bactériologie‐VirologieCHU MontpellierMontpellierFrance
| | - Stephane Chevaliez
- Department of VirologyFrench National Reference Center for Viral Hepatitis B, C and DeltaHopital Henri MondorUniversité Paris‐EstCréteilFrance
| | - Yusuke Shimakawa
- Unité d'Épidémiologie des Maladies ÉmergentesInstitut PasteurParisFrance
| | | | - Mark R. Thursz
- Department of HepatologyImperial College LondonSt Mary's HospitalLondonUK
| | - Ashley S. Brown
- Department of HepatologyImperial College LondonSt Mary's HospitalLondonUK
| | - Maud Lemoine
- Department of HepatologyImperial College LondonSt Mary's HospitalLondonUK
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López-Martínez R, Arias-García A, Rodríguez-Algarra F, Castellote-Bellés L, Rando-Segura A, Tarraso G, Vargas-Accarino E, Montserrat-Lloan I, Blanco-Grau A, Caballero-Garralda A, Ferrer-Costa R, Pumarola-Sunye T, Buti-Ferret M, Esteban-Mur R, Quer J, Casis-Saez E, Rodríguez-Frías F. Significant Improvement in Diagnosis of Hepatitis C Virus Infection by a One-Step Strategy in a Central Laboratory: an Optimal Tool for Hepatitis C Elimination? J Clin Microbiol 2019; 58:e01815-19. [PMID: 31694971 PMCID: PMC6935937 DOI: 10.1128/jcm.01815-19] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/30/2019] [Accepted: 10/31/2019] [Indexed: 02/07/2023] Open
Abstract
The remarkable effectivity of current antiviral therapies has led to consider the elimination of hepatitis C virus (HCV) infection. However, HCV infection is highly underdiagnosed; therefore, a global strategy for eliminating it requires improving the effectiveness of HCV diagnosis to identify hidden cases. In this study, we assessed the effectiveness of a protocol for HCV diagnosis based on viral load reflex testing of anti-HCV antibody-positive patients (known as one-step diagnosis) by analyzing all diagnostic tests performed by a central laboratory covering an area of 1.5 million inhabitants in Barcelona, Spain, before (83,786 cases) and after (45,935 cases) the implementation of the reflex testing protocol. After its implementation, the percentage of anti-HCV-positive patients with omitted HCV RNA determination remarkably decreased in most settings, particularly in drug treatment centers and primary care settings, where omitted HCV RNA analyses had absolute reductions of 76.4 and 20.2%, respectively. In these two settings, the percentage of HCV RNA-positive patients identified as a result of reflex testing accounted for 55 and 61% of all anti-HCV-positive patients. HCV RNA results were provided in a mean of 2 days. The presence of HCV RNA and age of ≥65 years were significantly associated with advanced fibrosis, assessed using the serological FIB-4 index (odds ratio [OR], 5.92; 95% confidence interval [CI], 3.4 to 10.4). The implementation of viral load reflex testing in a central laboratory is feasible and significantly increases the diagnostic effectiveness of HCV infections, while allowing the identification of underdiagnosed cases.
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Affiliation(s)
- Rosa López-Martínez
- Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
| | - Andrea Arias-García
- Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
| | - Francisco Rodríguez-Algarra
- Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom
| | - Laura Castellote-Bellés
- Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
| | - Ariadna Rando-Segura
- PROSICS Barcelona, Microbiology, University Hospital Vall d'Hebron, Barcelona, Spain
- Department of Microbiology (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
| | - Guillermo Tarraso
- Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
| | - Elena Vargas-Accarino
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
| | - Isabel Montserrat-Lloan
- Department of Haematology and Haemotherapy, University Hospital Vall d'Hebron, Barcelona, Spain
| | - Albert Blanco-Grau
- Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
| | - Andrea Caballero-Garralda
- Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
| | - Roser Ferrer-Costa
- Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
| | - Tomas Pumarola-Sunye
- PROSICS Barcelona, Microbiology, University Hospital Vall d'Hebron, Barcelona, Spain
- Department of Microbiology (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Bioscience and Medicine Schools, Autonomous University of Barcelona (UAB), Barcelona, Spain
| | - Maria Buti-Ferret
- Department of Internal Medicine and Hepatology, University Hospital Vall d'Hebron, Barcelona, Spain
- Liver Unit-Internal Medicine, Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBEREHD), Carlos III Institute, Madrid, Spain
- Bioscience and Medicine Schools, Autonomous University of Barcelona (UAB), Barcelona, Spain
| | - Rafael Esteban-Mur
- Department of Internal Medicine and Hepatology, University Hospital Vall d'Hebron, Barcelona, Spain
- Liver Unit-Internal Medicine, Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBEREHD), Carlos III Institute, Madrid, Spain
- Bioscience and Medicine Schools, Autonomous University of Barcelona (UAB), Barcelona, Spain
| | - Josep Quer
- Department of Internal Medicine and Hepatology, University Hospital Vall d'Hebron, Barcelona, Spain
- Liver Unit-Internal Medicine, Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBEREHD), Carlos III Institute, Madrid, Spain
| | - Ernesto Casis-Saez
- Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
| | - Francisco Rodríguez-Frías
- Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain
- Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain
- Liver Unit-Internal Medicine, Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBEREHD), Carlos III Institute, Madrid, Spain
- Bioscience and Medicine Schools, Autonomous University of Barcelona (UAB), Barcelona, Spain
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20
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Wlassow M, Poiteau L, Roudot-Thoraval F, Rosa I, Soulier A, Hézode C, Ortonne V, Pawlotsky JM, Chevaliez S. The new Xpert HCV viral load real-time PCR assay accurately quantifies hepatitis C virus RNA in serum and whole-blood specimens. J Clin Virol 2019; 117:80-84. [PMID: 31254912 DOI: 10.1016/j.jcv.2019.06.007] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2019] [Revised: 06/11/2019] [Accepted: 06/21/2019] [Indexed: 01/03/2023]
Abstract
BACKGROUND Sensitive and accurate hepatitis C virus (HCV) RNA detection and quantification are essential to diagnose and monitor the virological response to antiviral treatment and the emergence of resistance. OBJECTIVE AND STUDY DESIGN The aim of this study was to assess the ability of the new Xpert HCV Viral Load assay to accurately detect and quantify HCV RNA in serum and in whole blood collected on dried blood spot (DBS). Serum and whole blood from a large series of patients chronically infected with different HCV genotypes were tested in parallel for HCV RNA detection and quantification. RESULTS A significant relationship between HCV RNA levels measured with the Xpert HCV Viral Load assay and the two commercial real-time PCR comparators (Abbott RealTime HCV test and Cobas AmpliPrep/Cobas Taqman HCV 2.0 test) was found in serum as well as in whole blood specimens. CONCLUSIONS The Xpert HCV Viral Load assay accurately quantifies HCV RNA regardless of the HCV genotype and can thus confidently be used to detect active HCV infection in serum and in whole blood specimens.
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Affiliation(s)
- Mélanie Wlassow
- National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, hôpital Henri Mondor, France; INSERM U955, Créteil, France
| | - Lila Poiteau
- National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, hôpital Henri Mondor, France; INSERM U955, Créteil, France
| | | | - Isabelle Rosa
- Department of Hepatology and Gastroenterology, hôpital Henri Mondor, France
| | - Alexandre Soulier
- National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, hôpital Henri Mondor, France; INSERM U955, Créteil, France
| | - Christophe Hézode
- Department of Hepatology and Gastroenterology, Centre Hospitalier Intercommunal de Créteil, France; INSERM U955, Créteil, France
| | - Valérie Ortonne
- National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, hôpital Henri Mondor, France; INSERM U955, Créteil, France
| | - Jean-Michel Pawlotsky
- National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, hôpital Henri Mondor, France; INSERM U955, Créteil, France
| | - Stéphane Chevaliez
- National Reference Center for Viral Hepatitis B, C, and Delta, Department of Virology, hôpital Henri Mondor, France; INSERM U955, Créteil, France.
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21
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Williams B, Howell J, Doyle J, Thompson AJ, Draper B, Layton C, Latham N, Bramwell F, Membrey D, Mcpherson M, Roney J, Stoové M, Hellard ME, Pedrana A. Point-of-care hepatitis C testing from needle and syringe programs: An Australian feasibility study. THE INTERNATIONAL JOURNAL OF DRUG POLICY 2019; 72:91-98. [PMID: 31129023 DOI: 10.1016/j.drugpo.2019.05.012] [Citation(s) in RCA: 40] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2019] [Revised: 05/10/2019] [Accepted: 05/11/2019] [Indexed: 12/20/2022]
Abstract
BACKGROUND Achieving hepatitis C elimination requires novel approaches to engage people at highest risk of infection into care pathways. Point-of-care-tests may help to overcome some of the barriers preventing people who inject drugs (PWID) accessing testing and progressing to treatment for hepatitis C virus (HCV). We assessed the feasibility and acceptability of HCV point-of-care testing at needle and syringe exchange programs (NSPs) co-located in three community health clinics in Melbourne, Australia. METHODS NSP clients were offered an oral fluid point-of-care test for HCV antibody by NSP staff. Positive HCV antibody tests were followed by a point-of-care test for HCV RNA alongside standard-of-care laboratory testing for hepatitis C treatment work-up. Participants were offered same-day point-of-care results on site, via phone or text message, or upon return to the service. Participants were scheduled for follow-up review with the study nurse for assessment and linkage to treatment. RESULTS A total of 174 participants completed HCV antibody point-of-care test; 150 (86%) had a reactive result. Of these, 140 (93%) underwent a HCV RNA point-of-care test and 76 (54%) tested positive; few participants (5%) waited on site for results delivery, but the majority of RNA positive (63%) attended a follow-up visit for treatment work-up (median time to follow-up visit = 11 days; IQR = 7-20 days). The majority of participants reported a preference for point-of-care tests (66%) and supported NSP staff involvement in testing (90%). CONCLUSION Provision of HCV point-of-care tests, follow-up and linkage to treatment services through NSPs was feasible and acceptable to PWID. Despite few participants waiting to receive same-day results, there was effective linkage to care, suggesting value in further evaluation of this approach.
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Affiliation(s)
- Bridget Williams
- Disease Elimination Program, Burnet Institute, Melbourne, Australia.
| | - Jessica Howell
- Disease Elimination Program, Burnet Institute, Melbourne, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia; Department of Medicine, University of Melbourne, Melbourne, Australia
| | - Joseph Doyle
- Disease Elimination Program, Burnet Institute, Melbourne, Australia; Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Australia
| | - Alexander J Thompson
- Department of Gastroenterology, St Vincent's Hospital, Melbourne, Australia; Department of Medicine, University of Melbourne, Melbourne, Australia
| | - Bridget Draper
- Disease Elimination Program, Burnet Institute, Melbourne, Australia
| | - Chloe Layton
- Cohealth, General Practice, Melbourne, Australia
| | - Ned Latham
- Disease Elimination Program, Burnet Institute, Melbourne, Australia; Department of Infectious Diseases, Monash University, Melbourne, Australia
| | | | - Dean Membrey
- Cohealth, General Practice, Melbourne, Australia
| | - Maggie Mcpherson
- North Richmond Community Health, General Practice, Melbourne, Australia
| | - Janine Roney
- Department of Infectious Diseases, The Alfred, Melbourne, Australia
| | - Mark Stoové
- Disease Elimination Program, Burnet Institute, Melbourne, Australia
| | - Margaret E Hellard
- Disease Elimination Program, Burnet Institute, Melbourne, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Australia
| | - Alisa Pedrana
- Disease Elimination Program, Burnet Institute, Melbourne, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
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