|
1
|
Belota RCC, Silva JDM, do Nascimento EL, Abrahim CMDM, Castilho MC, Moura Neto JP, Albuquerque SRL. Safety of Hepatitis B Virus Screening in Blood Donors from the Hospital Foundation of Hematology and Hemotherapy of the State of Amazonas (HEMOAM) in the Brazilian Amazon. Viruses 2024; 16:1632. [PMID: 39459965 PMCID: PMC11512298 DOI: 10.3390/v16101632] [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: 08/20/2024] [Revised: 10/11/2024] [Accepted: 10/14/2024] [Indexed: 10/28/2024] Open
Abstract
BACKGROUND Hepatitis B is an infectious disease of worldwide importance and of great interest to transfusion medicine. The Amazon region has areas of high endemicity, outlining a worrying scenario for transfusion and epidemiological safety. OBJECTIVE To analyze the profiles of serological and molecular markers for HBV of blood donors from HEMOAM. METHODS Blood donors with different patterns of reactivity in serological and molecular screening for HBV were tested for viral load by the qPCR method at the reference center for liver diseases in the state of Amazonas. RESULTS A total of 230,591 donors were tested, with 3104 (1.34%) found reactive for HBV and 2790 (89.9%) found reactive for isolated anti-HBc. Viral load was not detected in 100% of donors reactive only to HBsAg, while 100% of donors with positive anti-HBc and positive HBsAg or HBV NAT demonstrated a detectable viral load. We also detected one case of occult hepatitis B (0.03%) only with reactive HBV NAT and five donors (0.2%) with positive anti-HBc and HBV NAT. CONCLUSIONS With this result, the great importance of the anti-HBc test for the unsuitability of blood donors was verified, as well as the fundamental introduction of the HBV NAT test in screening for hepatitis B in Brazilian blood banks, as this was the only way to detect the viral infection burden in asymptomatic donors who previously would not be treated, which contributed to the maintenance of the endemicity of hepatitis B in the Brazilian Amazon.
Collapse
Affiliation(s)
- Rosa Cristina Caldas Belota
- Programa de Pós-Graduação em Hematologia e Hemoterapia do Amazonas (PPGH/UEA/HEMOAM), Manaus 69050-001, Amazonas, Brazil; (R.C.C.B.); (E.L.d.N.); (C.M.d.M.A.); (J.P.M.N.)
| | - Jean de Melo Silva
- Programa de Pós-Graduação em Imunologia Básica e Aplicada (PPGIBA/UFAM), Manaus 69080-900, Amazonas, Brazil;
| | - Eduardo Luiz do Nascimento
- Programa de Pós-Graduação em Hematologia e Hemoterapia do Amazonas (PPGH/UEA/HEMOAM), Manaus 69050-001, Amazonas, Brazil; (R.C.C.B.); (E.L.d.N.); (C.M.d.M.A.); (J.P.M.N.)
| | - Cláudia Maria de Moura Abrahim
- Programa de Pós-Graduação em Hematologia e Hemoterapia do Amazonas (PPGH/UEA/HEMOAM), Manaus 69050-001, Amazonas, Brazil; (R.C.C.B.); (E.L.d.N.); (C.M.d.M.A.); (J.P.M.N.)
| | - Márcia Costa Castilho
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado (FMT-HVD), Manaus 69036-110, Amazonas, Brazil;
| | - José Pereira Moura Neto
- Programa de Pós-Graduação em Hematologia e Hemoterapia do Amazonas (PPGH/UEA/HEMOAM), Manaus 69050-001, Amazonas, Brazil; (R.C.C.B.); (E.L.d.N.); (C.M.d.M.A.); (J.P.M.N.)
- Programa de Pós-Graduação em Imunologia Básica e Aplicada (PPGIBA/UFAM), Manaus 69080-900, Amazonas, Brazil;
- Programa de Pós-Graduação em Ciências Farmacêuticas (PPGCF/UFAM), Manaus 69080-900, Amazonas, Brazil
| | - Sérgio Roberto Lopes Albuquerque
- Programa de Pós-Graduação em Hematologia e Hemoterapia do Amazonas (PPGH/UEA/HEMOAM), Manaus 69050-001, Amazonas, Brazil; (R.C.C.B.); (E.L.d.N.); (C.M.d.M.A.); (J.P.M.N.)
- Programa de Pós-Graduação em Imunologia Básica e Aplicada (PPGIBA/UFAM), Manaus 69080-900, Amazonas, Brazil;
| |
Collapse
|
|
2
|
Faddy HM, Osiowy C, Custer B, Busch M, Stramer SL, Dean MM, Acutt J, Viennet E, van de Laar T, Tsoi WC, Styles C, Kiely P, Margaritis A, Kwon SY, Qiu Y, Deng X, Lewin A, Jørgensen SW, Erikstrup C, Juhl D, Sauleda S, Camacho Rodriguez BA, Soto Coral LJC, Gaviria García PA, Oota S, O'Brien SF, Wendel S, Castro E, Navarro Pérez L, Harvala H, Davison K, Reynolds C, Jarvis L, Grabarczyk P, Kopacz A, Łętowska M, O'Flaherty N, Young F, Williams P, Burke L, Chua SS, Muylaert A, Page I, Jones A, Niederhauser C, Vermeulen M, Laperche S, Gallian P, Satake M, Addas-Carvalho M, Blanco S, Gallego SV, Seltsam A, Weber-Schehl M, Al-Riyami AZ, Al Maamari K, Alawi FB, Pandey HC, França RA, Charlewood R. An international review of the characteristics of viral nucleic acid-amplification testing (NAT) reveals a trend towards the use of smaller pool sizes and individual donation NAT. Vox Sang 2024; 119:745-751. [PMID: 38516962 DOI: 10.1111/vox.13617] [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: 01/10/2024] [Revised: 02/19/2024] [Accepted: 03/03/2024] [Indexed: 03/23/2024]
Abstract
BACKGROUND AND OBJECTIVES Nucleic acid-amplification testing (NAT) is used for screening blood donations/donors for blood-borne viruses. We reviewed global viral NAT characteristics and NAT-yield confirmatory testing used by blood operators. MATERIALS AND METHODS NAT characteristics and NAT-yield confirmatory testing used during 2019 was surveyed internationally by the International Society of Blood Transfusion Working Party Transfusion-Transmitted Infectious Diseases. Reported characteristics are presented herein. RESULTS NAT was mainly performed under government mandate. Human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) NAT was performed on all donors and donation types, while selective testing was reported for West Nile virus, hepatitis E virus (HEV), and Zika virus. Individual donation NAT was used for HIV, HCV and HBV by ~50% of responders, while HEV was screened in mini-pools by 83% of responders performing HEV NAT. Confirmatory testing for NAT-yield samples was generally performed by NAT on a sample from the same donation or by NAT and serology on samples from the same donation and a follow-up sample. CONCLUSION In the last decade, there has been a trend towards use of smaller pool sizes or individual donation NAT. We captured characteristics of NAT internationally in 2019 and provide insights into confirmatory testing approaches used for NAT-yields, potentially benefitting blood operators seeking to implement NAT.
Collapse
Affiliation(s)
- Helen M Faddy
- School of Health, University of the Sunshine Coast, Petrie, Queensland, Australia
- Research and Development, Australian Red Cross Lifeblood, Brisbane, Queensland, Australia
| | - Carla Osiowy
- National Microbiology Laboratory, Public Health Agency of Canada, Manitoba, Canada
| | - Brian Custer
- Vitalant Research Institute, San Francisco, California, USA
- Department of Laboratory Medicine, University of California San Francisco, California, USA
| | - Michael Busch
- Vitalant Research Institute, San Francisco, California, USA
| | | | - Melinda M Dean
- School of Health, University of the Sunshine Coast, Petrie, Queensland, Australia
- Research and Development, Australian Red Cross Lifeblood, Brisbane, Queensland, Australia
| | - Jessika Acutt
- School of Health, University of the Sunshine Coast, Petrie, Queensland, Australia
| | - Elvina Viennet
- Research and Development, Australian Red Cross Lifeblood, Brisbane, Queensland, Australia
| | - Thijs van de Laar
- Department of Donor Medicine Research, Sanquin Research, Amsterdam, The Netherlands
| | - Wai-Chiu Tsoi
- Hong Kong Red Cross Blood Transfusion Service, Hong Kong
| | - Claire Styles
- Pathology & Clinical Governance, Australian Red Cross Lifeblood, Melbourne, Australia
| | - Phil Kiely
- Pathology & Clinical Governance, Australian Red Cross Lifeblood, Melbourne, Australia
| | - Angelo Margaritis
- Manufacturing & Logistics, Australian Red Cross Lifeblood, Melbourne, Australia
| | - So-Yong Kwon
- Korean Red Cross Blood Services, Republic of Korea
| | - Yan Qiu
- Beijing Red Cross Blood Centre, Beijing, China
| | | | | | | | | | - David Juhl
- University Hospital of Schleswig-Holstein, Institute of Transfusion Medicine, Germany
| | | | | | | | | | | | | | | | - Emma Castro
- Centro de Transfusión de la Comunidad Valenciana, Spain
| | | | - Heli Harvala
- Microbiology Services, NHS Blood and Transplant, UK
| | | | | | - Lisa Jarvis
- Scottish National Blood Transfusion Service, UK
| | - Piotr Grabarczyk
- Institute of Hematology and Transfusion Medicine, Warsaw, Poland
| | - Aneta Kopacz
- Institute of Hematology and Transfusion Medicine, Warsaw, Poland
| | | | | | - Fiona Young
- Irish Blood Transfusion Service, Dublin, Ireland
| | | | - Lisa Burke
- Irish Blood Transfusion Service, Dublin, Ireland
| | | | | | - Isabel Page
- Centro de Hemoterapia y Hemodonacion de Castilla y Leon, Spain
| | | | - Christoph Niederhauser
- Interregional Blood Transfusion SRC, Switzerland
- Institute for Infectious Diseases, University of Berne, Berne, Switzerland
| | | | - Syria Laperche
- Etablissement Français du Sang, La Plaine Saint Denis, France
| | - Pierre Gallian
- Etablissement Français du Sang, La Plaine Saint Denis, France
| | | | | | | | - Sandra V Gallego
- Fundación Banco Central de Sangre, Argentina
- Virology Institute, School of Medicine, National University of Cordoba, Argentina
| | - Axel Seltsam
- Bavarian Red Cross Blood Donation Service, Wiesentheid, Germany
| | | | - Arwa Z Al-Riyami
- Sultan Qaboos University Hospital, Sultan Qaboos University, Oman
| | | | - Fatma Ba Alawi
- Sultan Qaboos University Hospital, Sultan Qaboos University, Oman
| | - Hem Chandra Pandey
- Department of Transfusion Medicine, All India Institute of Medical Sciences, New Delhi, India
| | | | | |
Collapse
|
|
3
|
Kourout M, Espich S, Fisher C, Tiper I, Purkayastha A, Smith S, Santana-Quintero L, Duncan R. Multiplex detection and identification of viral, bacterial, and protozoan pathogens in human blood and plasma using an expanded high-density resequencing microarray platform. Front Mol Biosci 2024; 11:1419213. [PMID: 38966129 PMCID: PMC11222771 DOI: 10.3389/fmolb.2024.1419213] [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: 04/17/2024] [Accepted: 05/23/2024] [Indexed: 07/06/2024] Open
Abstract
Introduction: Nucleic acid tests for blood donor screening have improved the safety of the blood supply; however, increasing numbers of emerging pathogen tests are burdensome. Multiplex testing platforms are a potential solution. Methods: The Blood Borne Pathogen Resequencing Microarray Expanded (BBP-RMAv.2) can perform multiplex detection and identification of 80 viruses, bacteria and parasites. This study evaluated pathogen detection in human blood or plasma. Samples spiked with selected pathogens, each with one of 6 viruses, 2 bacteria and 5 protozoans were tested on this platform. The nucleic acids were extracted, amplified using multiplexed sets of primers, and hybridized to a microarray. The reported sequences were aligned to a database to identify the pathogen. To directly compare the microarray to an emerging molecular approach, the amplified nucleic acids were also submitted to nanopore next generation sequencing (NGS). Results: The BBP-RMAv.2 detected viral pathogens at a concentration as low as 100 copies/ml and a range of concentrations from 1,000 to 100,000 copies/ml for all the spiked pathogens. Coded specimens were identified correctly demonstrating the effectiveness of the platform. The nanopore sequencing correctly identified most samples and the results of the two platforms were compared. Discussion: These results indicated that the BBP-RMAv.2 could be employed for multiplex detection with potential for use in blood safety or disease diagnosis. The NGS was nearly as effective at identifying pathogens in blood and performed better than BBP-RMAv.2 at identifying pathogen-negative samples.
Collapse
Affiliation(s)
- Moussa Kourout
- Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States
| | - Scott Espich
- Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States
| | - Carolyn Fisher
- Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States
| | - Irina Tiper
- Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States
| | | | - Sean Smith
- HIVE Team, Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States
| | - Luis Santana-Quintero
- HIVE Team, Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States
| | - Robert Duncan
- Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States
| |
Collapse
|
|
4
|
Faddy HM, Osiowy C, Custer B, Busch M, Stramer SL, Adesina O, van de Laar T, Tsoi WC, Styles C, Kiely P, Margaritis A, Kwon SY, Qiu Y, Deng X, Lewin A, Jørgensen SW, Erikstrup C, Juhl D, Sauleda S, Camacho Rodriguez BA, Coral LJCS, Gaviria García PA, Oota S, O'Brien SF, Wendel S, Castro E, Navarro Pérez L, Harvala H, Davison K, Reynolds C, Jarvis L, Grabarczyk P, Kopacz A, Łętowska M, O'Flaherty N, Young F, Williams P, Burke L, Chua SS, Muylaert A, Page I, Jones A, Niederhauser C, Vermeulen M, Laperche S, Gallian P, Sawadogo S, Satake M, Gharehbaghian A, Addas-Carvalho M, Blanco S, Gallego SV, Seltsam A, Weber-Schehl M, Al-Riyami AZ, Al Maamari K, Alawi FB, Pandey HC, Mbanya D, França RA, Charlewood R. International review of blood donation nucleic acid amplification testing. Vox Sang 2024; 119:315-325. [PMID: 38390819 DOI: 10.1111/vox.13592] [Citation(s) in RCA: 5] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2023] [Revised: 01/01/2024] [Accepted: 01/02/2024] [Indexed: 02/24/2024]
Abstract
BACKGROUND AND OBJECTIVES Nucleic acid amplification testing (NAT), in blood services context, is used for the detection of viral and parasite nucleic acids to reduce transfusion-transmitted infections. This project reviewed NAT for screening blood donations globally. MATERIALS AND METHODS A survey on NAT usage, developed by the International Society of Blood Transfusion Working Party on Transfusion-transmitted Infectious Diseases (ISBT WP-TTID), was distributed through ISBT WP-TTID members. Data were analysed using descriptive statistics. RESULTS Forty-three responses were received from 32 countries. Increased adoption of blood donation viral screening by NAT was observed over the past decade. NAT-positive donations were detected for all viruses tested in 2019 (proportion of donations positive by NAT were 0.0099% for human immunodeficiency virus [HIV], 0.0063% for hepatitis C virus [HCV], 0.0247% for hepatitis B virus [HBV], 0.0323% for hepatitis E virus [HEV], 0.0014% for West Nile virus [WNV] and 0.00005% for Zika virus [ZIKV]). Globally, over 3100 NAT-positive donations were identified as NAT yield or solely by NAT in 2019 and over 22,000 since the introduction of NAT, with HBV accounting for over half. NAT-positivity rate was higher in first-time donors for all viruses tested except WNV. During 2019, a small number of participants performed NAT for parasites (Trypanosoma cruzi, Babesia spp., Plasmodium spp.). CONCLUSION This survey captures current use of blood donation NAT globally. There has been increased NAT usage over the last decade. It is clear that NAT contributes to improving blood transfusion safety globally; however, there is a need to overcome economic barriers for regions/countries not performing NAT.
Collapse
Affiliation(s)
- Helen M Faddy
- School of Health, University of the Sunshine Coast, Petrie, Queensland, Australia
- Research and Development, Australian Red Cross Lifeblood, Brisbane, Queensland, Australia
| | - Carla Osiowy
- National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada
| | - Brian Custer
- Vitalant Research Institute, San Francisco, California, USA
- Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA
| | - Michael Busch
- Vitalant Research Institute, San Francisco, California, USA
| | - Susan L Stramer
- Scientific Affairs, American Red Cross, Gaithersburg, Maryland, USA
| | | | - Thijs van de Laar
- Department of Donor Medicine Research, Sanquin Research, Amsterdam, the Netherlands
| | - Wai-Chiu Tsoi
- Hong Kong Red Cross Blood Transfusion Service, Kowloon, Hong Kong
| | - Claire Styles
- Pathology & Clinical Governance, Australian Red Cross Lifeblood, Melbourne, Victoria, Australia
| | - Phil Kiely
- Pathology & Clinical Governance, Australian Red Cross Lifeblood, Melbourne, Victoria, Australia
| | - Angelo Margaritis
- Manufacturing & Logistics, Australian Red Cross Lifeblood, Melbourne, Victoria, Australia
| | - So-Yong Kwon
- Korean Red Cross Blood Services, Wonju, Republic of Korea
| | - Yan Qiu
- Beijing Red Cross Blood Centre, Beijing, China
| | | | - Antoine Lewin
- Medical Affairs and Innovation, Héma-Québec, Saint-Laurent, Quebec, Canada
| | | | - Christian Erikstrup
- Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark
| | - David Juhl
- University Hospital of Schleswig-Holstein, Institute of Transfusion Medicine, Kiel, Germany
| | | | | | | | | | - Sineenart Oota
- National Blood Centre, Thai Red Cross Society, Bangkok, Thailand
| | | | | | - Emma Castro
- Centro de Transfusión de la Comunidad Valenciana, Valencia, Spain
| | | | - Heli Harvala
- Microbiology Services, NHS Blood and Transplant, Bristol, UK
| | - Katy Davison
- NHSBT/UKHSA Epidemiology Unit, UKHSA, London, UK
| | | | - Lisa Jarvis
- Scottish National Blood Transfusion Service, Edinburgh, Scotland, UK
| | - Piotr Grabarczyk
- Institute of Hematology and Transfusion Medicine, Warsaw, Poland
| | - Aneta Kopacz
- Institute of Hematology and Transfusion Medicine, Warsaw, Poland
| | | | | | - Fiona Young
- Irish Blood Transfusion Service, Dublin, Ireland
| | | | - Lisa Burke
- Irish Blood Transfusion Service, Dublin, Ireland
| | | | | | - Isabel Page
- Centro de Hemoterapia y Hemodonacion de Castilla y Leon, Valladolid, Spain
| | - Ann Jones
- Welsh Blood Service, Pontyclun, Wales, UK
| | | | - Marion Vermeulen
- The South African National Blood Service, Weltevreden Park, South Africa
| | - Syria Laperche
- Etablissement Français du Sang, La Plaine Saint Denis, Tours, France
| | - Pierre Gallian
- Etablissement Français du Sang, La Plaine Saint Denis, Tours, France
| | - Salam Sawadogo
- National Blood Transfusion Center of Burkina Faso, Ouagadougou, Burkina Faso
| | | | - Ahmad Gharehbaghian
- Laboratory Hematology & Blood Bank Department, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | | | | | - Sandra V Gallego
- Fundación Banco Central de Sangre, Córdoba, Argentina
- Virology Institute, School of Medicine, National University of Cordoba, Córdoba, Argentina
| | - Axel Seltsam
- Bavarian Red Cross Blood Donation Service, Wiesentheid, Germany
| | | | - Arwa Z Al-Riyami
- Sultan Qaboos University Hospital, Sultan Qaboos University, Muscat, Oman
| | - Khuloud Al Maamari
- Sultan Qaboos University Hospital, Sultan Qaboos University, Muscat, Oman
| | - Fatma Ba Alawi
- Sultan Qaboos University Hospital, Sultan Qaboos University, Muscat, Oman
| | - Hem Chandra Pandey
- Department of Transfusion Medicine, All India Institute of Medical Sciences, New Delhi, India
| | - Dora Mbanya
- National Blood Transfusion Service, Yaoundé, Cameroon
| | | | | |
Collapse
|
|
5
|
Sauleda S, Bes M, Piron M, Ong E, Coco SB, Carrió J, Linnen JM. Clinical performance of a new multiplex assay for the detection of HIV-1, HIV-2, HCV, HBV, and HEV in blood donations in Catalonia (Spain). Transfusion 2023; 63:2098-2105. [PMID: 37767741 DOI: 10.1111/trf.17518] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/12/2023] [Revised: 08/12/2023] [Accepted: 08/12/2023] [Indexed: 09/29/2023]
Abstract
BACKGROUND Commercial multiplex nucleic acid tests (NATs) for HIV-1/HIV-2/HCV/HBV are widely used in developed countries to screen blood donations. HEV NAT screening has been implemented in some blood banks but is tested with a different assay. STUDY DESIGN AND METHODS This study describes the clinical sensitivity and specificity of the Procleix® UltrioPlex E (UPxE) assay on the automated Procleix Panther® system for the simultaneous detection of HIV-1/HIV-2/HCV/HBV/HEV. To evaluate routine performance, 10,138 donations were tested in parallel with UPxE (in ID-NAT) and current assays (Procleix Ultrio Elite [UE] assay in ID-NAT and Procleix HEV assay in pool of 16). To assess clinical sensitivity, archived donations positive for HCV, HIV-1, HBV, HEV, or occult HBV infection (OBI) were tested (n = 104-186). RESULTS Five donations were initially reactive (IR) with UPxE; none of them were reactive with current assays. Two of the three samples IR for HIV-1/HIV-2/HCV/HBV were confirmed positive for HBV (HBV NAT and/or anti-HBV core positive) and classified as OBI. The two samples IR for HEV were confirmed positive (Procleix HEV assay in ID-NAT and in-house RT-PCR HEV assay). One sample IR for HIV-1/HIV-2/HCV/HBV with UPxE and another with UE were not confirmed. UPxE showed a specificity of 99.99% for HIV-1/HIV-2/HCV/HBV and 100% for HEV. Comparable sensitivities were observed for HIV-1, HCV, HBV, OBI, and HEV samples tested in the UPxE, UE, and Procleix HEV assays. DISCUSSION UPxE may provide an efficient solution for the simultaneous detection of HIV-1, HIV-2, HCV, HBV, and HEV in blood donations in a single test.
Collapse
Affiliation(s)
- Silvia Sauleda
- Banc de Sang i Teixits de Catalunya (Blood and Tissue Bank of Catalonia, BST), Transfusion Safety Laboratory, Barcelona, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREhd), Instituto de Salud Carlos III, Madrid, Spain
- Transfusional Medicine Group, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain
| | - Marta Bes
- Banc de Sang i Teixits de Catalunya (Blood and Tissue Bank of Catalonia, BST), Transfusion Safety Laboratory, Barcelona, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREhd), Instituto de Salud Carlos III, Madrid, Spain
- Transfusional Medicine Group, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain
| | - Maria Piron
- Banc de Sang i Teixits de Catalunya (Blood and Tissue Bank of Catalonia, BST), Transfusion Safety Laboratory, Barcelona, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREhd), Instituto de Salud Carlos III, Madrid, Spain
- Transfusional Medicine Group, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain
| | - Edgar Ong
- Grifols Diagnostic Solutions Inc., San Diego, California, USA
| | | | | | | |
Collapse
|
|
6
|
Cruz LJDN, Barile KADS, Amaral CEDM. Correlation of serological and molecular markers in the screening for hepatitis B virus in blood bank in northern Brazil. Hematol Transfus Cell Ther 2023; 45:428-434. [PMID: 36379884 PMCID: PMC10627861 DOI: 10.1016/j.htct.2022.07.003] [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: 03/15/2022] [Revised: 05/24/2022] [Accepted: 07/19/2022] [Indexed: 11/26/2022] Open
Abstract
INTRODUCTION In Brazil, the blood donor screening for hepatitis B virus (HBV) includes laboratory testing for serological (HBsAg and Anti-HBc) and molecular (HBV DNA) markers. This study aims to correlate serology reactive results with HBV DNA detection among blood donors with at least one HBV infection marker detected in a blood bank in northern Brazil. METHOD A retrospective search for HBV reactive blood donor data from January 2017 to December 2019 was performed. Serological screening was performed by chemiluminescent microparticle immunoassays Architect HBsAg and Architect Anti-HBc, whereas molecular screening was performed by the HBV nucleic acid test (HBV NAT). MAIN RESULTS A total of 556 HBsAg reactive results were detected, between positive (47.66%) and inconclusive (52.34%). A total of 3,658 Anti-HBc reactive results were detected, between positive (83.71%) and inconclusive (16.29%). None of the inconclusive results were associated with HBV DNA detection. The HBV DNA detection rates were 47.55% among HBsAg positive samples and 4.08% among Anti-HBc positive samples. The signal-to-cutoff (S/CO) ratio median of HBV NAT positive samples was superior in comparison to HBV NAT negative samples (p < 0.0001). The thresholds found to optimize sensitivity and specificity were 404.15 for Architect HBsAg and 7.77 for Architect Anti-HBc. Three blood donors were in the window period and 1 occult HBV infection case was detected. CONCLUSION High S/CO ratios were more predictive of HBV DNA detection. However, a number of HBV NAT positive samples gave low values, while some HBV NAT negative samples showed high values, reaffirming the significance of molecular testing to enhance transfusion safety.
Collapse
Affiliation(s)
- Lucas José do Nascimento Cruz
- Processamento do Sangue, Fundação Pró-Sangue Hemocentro de São Paulo, Av. Dr. Enéas Carvalho de Aguiar 155, São Paulo, SP, Brazil.
| | | | - Carlos Eduardo de Melo Amaral
- Gerência de Biologia Celular e Molecular, Fundação Centro de Hemoterapia e Hematologia do Pará (HEMOPA), Belém, PA, Brazil
| |
Collapse
|
|
7
|
Aguilera A, Fuentes A, Cea M, Carracedo R, Viñuela L, Ordóñez P, López-Fabal F, Sáez E, Cebrián R, Pérez-Revilla A, Pereira S, De Salazar A, García F. Real-life validation of a sample pooling strategy for screening of hepatitis C. Clin Microbiol Infect 2023; 29:112.e1-112.e4. [PMID: 36210627 DOI: 10.1016/j.cmi.2022.09.006] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2022] [Revised: 08/30/2022] [Accepted: 09/09/2022] [Indexed: 12/27/2022]
Abstract
OBJECTIVES To test a real-life sample pooling screening strategy which contributes to increasing the diagnostic capacity of clinical laboratories and expanding access to massive screening of hepatitis C. METHODS After evaluating the sensitivity of the pooling strategy for seven different commercial assays which are used to determine the concentration of hepatitis C virus (HCV)-RNA in the plasma or serum, consecutive samples submitted for HCV diagnosis during the first 3 weeks of November 2021 were tested for HCV antibodies and, in parallel and in a blinded way, were pooled into 100 samples and tested for HCV-RNA. When the result was positive, a strategy to un-mask the positive(s) pool(s), which needed up to 15 total HCV-RNA tests, was used. RESULTS All platforms were able to detect the presence of HCV-RNA in a single sample from a patient with viremic HCV present in pools of up to at least 10 000 HCV-RNA-free samples. A total of 1700 samples (17 pools) were analysed, with an overall prevalence of anti-HCV and HCV-RNA of 0.24%. After pooling, we could detect all samples previously detected using standard diagnosis tests (reflex testing) with a specificity and sensitivity of 100% (CI, 99.78-100%). Given the median current prices of anti-HCV and HCV-RNA on the market in Spain as well as personnel costs, testing using the pooling strategy would have resulted in a save of 3320€. CONCLUSIONS Here, we demonstrated that by improving cost effectiveness, with no loss of sensitivity and specificity, the strategy of pooling samples may serve as an appropriate tool for use in large-scale screening of HCV.
Collapse
Affiliation(s)
- Antonio Aguilera
- Servicio de Microbiología, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain; Departamento de Microbiología, Universidade de Santiago de Compostela, Santiago de Compostela, Spain; Instituto de Investigación Sanitaria de Santiago, Santiago de Compostela, Spain
| | - Ana Fuentes
- Servicio de Microbiología, Hospital Universitario Clínico San Cecilio, Granada, Spain; Instituto de Investigación Biosanitario Ibs.Granada, Spain
| | - María Cea
- Servicio de Microbiología, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
| | - Raquel Carracedo
- Servicio de Microbiología, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
| | - Laura Viñuela
- Servicio de Microbiología, Hospital Universitario Clínico San Cecilio, Granada, Spain; Instituto de Investigación Biosanitario Ibs.Granada, Spain
| | - Patricia Ordóñez
- Complejo Hospitalario Arquitecto Marcide-Profesor Novoa Santos, Ferrol, Spain
| | | | - Elena Sáez
- Laboratorio Central de la Comunidad de Madrid (URSALUD), Madrid, Spain
| | - Rubén Cebrián
- Servicio de Microbiología, Hospital Universitario Clínico San Cecilio, Granada, Spain; Instituto de Investigación Biosanitario Ibs.Granada, Spain
| | | | - Sara Pereira
- Servicio de Microbiología, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
| | - Adolfo De Salazar
- Servicio de Microbiología, Hospital Universitario Clínico San Cecilio, Granada, Spain; Instituto de Investigación Biosanitario Ibs.Granada, Spain; Ciber de Enfermedades Infecciosas, ISCIII, Spain
| | - Federico García
- Servicio de Microbiología, Hospital Universitario Clínico San Cecilio, Granada, Spain; Instituto de Investigación Biosanitario Ibs.Granada, Spain; Ciber de Enfermedades Infecciosas, ISCIII, Spain.
| |
Collapse
|
|
8
|
Niederhauser C, Tinguely C, Stolz M, Vock M, El Dusouqui SA, Gowland P. Evolution of Blood Safety in Switzerland over the Last 25 Years for HIV, HCV, HBV and Treponema pallidum. Viruses 2022; 14:v14122611. [PMID: 36560615 PMCID: PMC9787333 DOI: 10.3390/v14122611] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/30/2022] [Revised: 11/17/2022] [Accepted: 11/21/2022] [Indexed: 11/25/2022] Open
Abstract
During the last few decades, efforts to increase the safety of blood and blood products have mainly focused on preventing the viral infections HCV, HIV, HBV and Treponema pallidum. The evolution of these approaches and the achieved increase in safety is shown for the last 25 years in Switzerland. In detail, the prevalences and incidences of the infection disease and the theoretical estimated residual risks (RR) of these blood-borne infections are presented. Prevalences, incidences and, in particular, the RR have decreased considerably over the last 25 years. This was achieved primarily by the adoption of strict criteria for the selection of blood donors, refined questionnaires, the introduction of increasingly sensitive serological screening tests and the implementation of nucleic acid testing (NAT) for these blood-borne pathogens. These NAT assays have significantly shortened the window period between infection and the first detection of the infectious agent in the blood of an infected individual. A form of "real life" comparison or confirmation is provided by the reported lookback procedures (LBP) and the haemovigilance data of the Swiss competent authority, Swissmedic. These data are in agreement, and thus support the very low prevalences, incidences and RR.
Collapse
Affiliation(s)
- Christoph Niederhauser
- Interregional Blood Transfusion SRC, 3008 Bern, Switzerland
- Institute for Infectious Disease, University of Bern, 3001 Bern, Switzerland
- Faculté de Biologie et de Médecine, Université de Lausanne, 1015 Lausanne, Switzerland
- Correspondence: ; Tel.: +41-31-384-2304
| | | | - Martin Stolz
- Interregional Blood Transfusion SRC, 3008 Bern, Switzerland
| | - Michael Vock
- Institute of Mathematical Statistics and Actuarial Science, University of Bern, 3012 Bern, Switzerland
| | | | - Peter Gowland
- Interregional Blood Transfusion SRC, 3008 Bern, Switzerland
| |
Collapse
|
|
9
|
Insights on 21 Years of HBV Surveillance in Blood Donors in France. Viruses 2022; 14:v14112507. [PMID: 36423116 PMCID: PMC9693332 DOI: 10.3390/v14112507] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/14/2022] [Revised: 11/07/2022] [Accepted: 11/09/2022] [Indexed: 11/16/2022] Open
Abstract
Hepatitis B virus (HBV) infection is the most frequent viral infection found in blood donors (BDs) in France. We analyzed the epidemiological and sero-molecular data on HBV infection gathered over the past two decades by the French haemovigilance surveillance network, blood screening laboratories, and the national reference center for transfusion infectious risks (NRC). Between 2000 and 2020, 6149 of the 58,160,984 donations (1.06/10,000) tested HBV positive, 98% of them from first-time blood donors (FTBDs). In addition, 2212 (0.0071%) of the 30,977,753 donations screened for HBV DNA tested DNA positive, of which 25 (1.1%) were positive only for this marker. HBV prevalence decreased by 2.8-fold and the residual risk for transfusion-transmitted HBV infection decreased 13-fold and was divided by 13. The major risk factor for HBV infection was the origin of donors (endemic country, 66.5%), followed by parenteral exposure (10.7%). In the whole HBV-positive BD population, genotype D was predominant (41.8%), followed by genotypes A (26.2%) and E (20.4%), reflecting the geographical origin of donors. The low and decreasing prevalence and incidence of HBV infection in French BDs, coupled with a screening strategy using three HBV markers (HBsAg, anti-HBc and DNA), ensures a high level of blood safety, further reinforced by the implementation of pathogen-reduction measures.
Collapse
|
|
10
|
Luz E, Marques M, Netto EM, Campos LM, Amaral S, Santana I, Marques EL, Brites C. HIV, HTLV, and Hepatitis B and C Infection in Blood Donors in Bahia, Brazil from 2008 to 2017. Viruses 2022; 14:v14112323. [PMID: 36366422 PMCID: PMC9692744 DOI: 10.3390/v14112323] [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: 09/09/2022] [Revised: 10/13/2022] [Accepted: 10/19/2022] [Indexed: 11/06/2022] Open
Abstract
Although blood transfusion is an important therapeutic resource, transfusion-transmitted infections (TTIs) are still a cause for concern. Measures to mitigate this risk involve improvement of donor screening criteria and improvements in laboratory tests, especially the use of nucleic acid test (NAT). In this retrospective study we evaluated HIV, HTLV, HCV and HBV infection rates in blood donors of the Hematology and Hemotherapy Foundation of Bahia (Hemoba), Brazil, through serological and NAT results and the characteristics of donors. From February/2008 to December/2017, 777,446 blood donations were made. Most donors were male, aged 25-44 years, black and mixed race, and single or divorced. The density-type incidence (DTI; per 100,000) for each virus was 91.1 for HBV; 66.5 for HCV; 54.3 for HIV; and 33.9 for HTLV, with a decreasing trend observed over the period studied, except in the last biennium. NAT detected only 1 donor in immunological window for HIV (0.46/100,000 donations) and 3 donors in immunological window for HBV (1.8/100,000 donations). Serological positivity for all viruses studied was higher in the metropolitan region of Salvador, the state capital. Conclusion: DTI rates show a decreasing trend over the years studied, with a predominance of HBV infection. NAT allowed the detection of donors in immunological window periods, having an important role in improving transfusion safety.
Collapse
Affiliation(s)
- Estela Luz
- Programa de Pós-Graduação em Medicina e Saúde, Universidade Federal da Bahia, Salvador 40110-060, BA, Brazil
- Laboratório de Pesquisa em Infectologia, Hospital Universitário Professor Edgard Santos, Salvador 40110-060, BA, Brazil
- Fundação Bahiana de Infectologia, Salvador 40110-160, BA, Brazil
| | - Marinho Marques
- Fundação de Hematologia e Hemoterapia da Bahia, Salvador 40286-240, BA, Brazil
- Departamento de Ciências da Vida, Universidade do Estado da Bahia, Salvador 41180-045, BA, Brazil
| | - Eduardo Martins Netto
- Programa de Pós-Graduação em Medicina e Saúde, Universidade Federal da Bahia, Salvador 40110-060, BA, Brazil
- Laboratório de Pesquisa em Infectologia, Hospital Universitário Professor Edgard Santos, Salvador 40110-060, BA, Brazil
- Fundação Bahiana de Infectologia, Salvador 40110-160, BA, Brazil
| | | | - Sávio Amaral
- Programa de Pós-Graduação em Medicina e Saúde, Universidade Federal da Bahia, Salvador 40110-060, BA, Brazil
- Laboratório de Pesquisa em Infectologia, Hospital Universitário Professor Edgard Santos, Salvador 40110-060, BA, Brazil
- Fundação Bahiana de Infectologia, Salvador 40110-160, BA, Brazil
| | - Iraildes Santana
- Fundação de Hematologia e Hemoterapia da Bahia, Salvador 40286-240, BA, Brazil
| | | | - Carlos Brites
- Programa de Pós-Graduação em Medicina e Saúde, Universidade Federal da Bahia, Salvador 40110-060, BA, Brazil
- Laboratório de Pesquisa em Infectologia, Hospital Universitário Professor Edgard Santos, Salvador 40110-060, BA, Brazil
- Fundação Bahiana de Infectologia, Salvador 40110-160, BA, Brazil
- Correspondence:
| |
Collapse
|
|
11
|
Busch MP. Four decades of HIV and transfusion safety: Much accomplished but ongoing challenges. Transfusion 2022; 62:1334-1339. [PMID: 35815724 DOI: 10.1111/trf.16931] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2022] [Accepted: 05/16/2022] [Indexed: 11/28/2022]
Affiliation(s)
- Michael P Busch
- Vitalant Research Institute, University of California, San Francisco, California, USA
| |
Collapse
|
|
12
|
Mabunda N, Augusto O, Zicai AF, Duajá A, Oficiano S, Ismael N, Vubil A, Mussá T, Moraes M, Jani I. Nucleic acid testing identifies high prevalence of blood borne viruses among approved blood donors in Mozambique. PLoS One 2022; 17:e0267472. [PMID: 35482726 PMCID: PMC9049559 DOI: 10.1371/journal.pone.0267472] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2021] [Accepted: 04/09/2022] [Indexed: 11/26/2022] Open
Abstract
Background Although blood transfusion is an intervention that saves lives, it poses significant risks to the blood receivers, including the transmission of bloodborne pathogens. We aimed at determining the prevalence of Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) in candidates approved for blood donation, and in samples considered to be negative in reference blood banks in Mozambique. Methods A cross-sectional study was performed between November 2014 and October 2015 in Maputo and Beira cities. Demographic information was obtained from all consenting blood donors using a structured questionnaire. Plasma samples were screened for HIVAb/Ag combinations, HBsAg and Anti-HCV. Blood donors considered to be negative by serological testing were re-tested in pools of six plasma samples using nucleic acid testing (NAT). Results Most blood donors were male 2,320 (83.4%) with an age range of 18 to 34 years. The overall seroprevalence of HIV, HBV and HCV infections among blood donors approved for donation was 4.6% (127; 95% CI 3.8–5.4), 4.5% (124; 95% CI 3.7–5.3) and 0.4% (11; 95% CI 0.2–0.7), respectively. The overall frequency by NAT of HIV RNA, HBV DNA, and HCV RNA in serologically negative blood donor samples was 2.6 per 1000 blood donors (7; 95% CI 1.1–5.4); 12.5 per 1000 blood donors (33; 95% CI 8.6–17.5) and 2.6 per 1000 blood donors (6; 95% CI 1.0–5.7), respectively. Conclusion Our results show high seroprevalence of HIV and HBV infections in blood donors approved for donation, and high frequency of molecular biomarkers of HIV, HBV, and HCV in blood considered to be safe. These results suggest the need for a new blood screening policy in Mozambique, including the use of NAT to detect infectious blood donations during the immunologically negative window.
Collapse
Affiliation(s)
- Nédio Mabunda
- Instituto Nacional de Saúde, Marracuene, Mozambique
- Laboratório de Hanseníase, Instituto Oswaldo Cruz, FIOCRUZ, Brasil
- * E-mail:
| | - Orvalho Augusto
- Faculty of Medicine, Universidade Eduardo Mondlane, Maputo, Mozambique
| | | | - Ana Duajá
- Instituto Nacional de Saúde, Marracuene, Mozambique
- Hospital Central da Beira, Sofala, Mozambique
| | | | - Nalia Ismael
- Instituto Nacional de Saúde, Marracuene, Mozambique
| | - Adolfo Vubil
- Instituto Nacional de Saúde, Marracuene, Mozambique
| | - Tufária Mussá
- Faculty of Medicine, Universidade Eduardo Mondlane, Maputo, Mozambique
| | - Milton Moraes
- Laboratório de Hanseníase, Instituto Oswaldo Cruz, FIOCRUZ, Brasil
| | - Ilesh Jani
- Instituto Nacional de Saúde, Marracuene, Mozambique
| |
Collapse
|
|
13
|
Schmidt M, Ramirez-Arcos S, Stiller L, McDonald C. Current status of rapid bacterial detection methods for platelet components: A 20-year review by the ISBT Transfusion-Transmitted Infectious Diseases Working Party Subgroup on Bacteria. Vox Sang 2022; 117:983-988. [PMID: 35412655 DOI: 10.1111/vox.13283] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/14/2021] [Revised: 01/17/2022] [Accepted: 02/10/2022] [Indexed: 11/29/2022]
Abstract
BACKGROUND AND OBJECTIVES Bacterial contamination of platelet components (PCs) poses a safety challenge for transfusion patients. Despite mitigation interventions, the residual risk of transfusion-transmitted bacterial infections remains predominant. PC safety can be improved either by pathogen reduction or by implementation of bacterial detection methods. Detection methodologies include culture methods and rapid detection methods. The current review focuses on currently available rapid detection methods. MATERIALS AND METHODS We reviewed published manuscripts since 2000 on rapid bacterial detection methods used for PC screening with result determination within 4 h. Methods meeting this criterion included Verax PGDprime, BacTx and nucleic amplification testing. The analytical and diagnostic sensitivity and specificity of these systems were assessed. RESULTS The analytical sensitivity between the different detection methods ranged between 50 and 100,000 CFU/ml. The sample volume used by these testing systems varies between 0.5 and 1.0 ml of PCs. A delay of at least 48 h before sampling enhances detectability. All rapid detection methods generate results in a timely manner, allowing testing to be performed before transfusion with optimal sensitivity. CONCLUSION Rapid detection methods improve PC safety regarding bacterial contamination. The assays are optimal for rapidly growing bacteria, which are more likely to cause septic transfusion reactions in patients. Because of the reduced diagnostic sensitivity, the sample collection should be late in shelf-life and ideally just before transfusion. The major benefit of these methods is that the test result can be obtained before releasing PCs for transfusion or to be used in combination with other screening methods applied early during PC storage.
Collapse
Affiliation(s)
| | - Sandra Ramirez-Arcos
- Department of Microbiology, Canadian Blood Services, Ottawa, Ontario, Canada.,Department of Microbiology, University of Ottawa, Ottawa, Ontario, Canada
| | - Lea Stiller
- German Red Cross, Institute Frankfurt, Frankfurt, Germany
| | | | | |
Collapse
|
|
14
|
Pawar A, Jagani R, Dimri U, Kumar S. Experience of individual donor nucleic acid testing on screening of blood donors for human immunodeficiency virus, hepatitis c virus, and hepatitis b virus at an Apex blood bank of Northern India. MEDICAL JOURNAL OF DR. D.Y. PATIL VIDYAPEETH 2022. [DOI: 10.4103/mjdrdypu.mjdrdypu_344_20] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
|
|
15
|
Amini-Kafiabad S, Pourfatollah AA. Viral safety of recovered plasma for contract fractionation; an Iranian experience, 2006-2015. Transfus Med 2021; 32:64-70. [PMID: 34820928 DOI: 10.1111/tme.12833] [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: 05/04/2021] [Revised: 09/17/2021] [Accepted: 11/04/2021] [Indexed: 11/27/2022]
Abstract
OBJECTIVE The current study analysed the viral safety among Iranian blood donors. BACKGROUND Plasma products demand is increasing in the world. With contract plasma fractionation, the plasma wastage decreases and the access of patients to plasma-derived medicines (PDM) improves. STUDY AND DESIGN METHOD Screening results including hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), and human immunodeficiency virus (HIV) Ag/Ab of 19 054 036 donations from 2006 to 2015 were analysed. The plasma for fractionation was tested for HBV DNA, HCV RNA, HIV RNA, HAV RNA, and Parvovirus B19 DNA by fractionators. New samples were collected from the positive donors and retested. The prevalence of serological and nucleic acid testing (NAT) markers per 105 donations, 95% confidential interval (CI), and p-values were calculated. RESULTS The prevalence of markers was as follows: 250/105 donations for HBsAg from 516 in 2006 to 116/105 donations in 2015; 74/105 donations for HCV, decreasing from 127 to 41/105 and 3.6/105 for HIV during current study. During 10 years, 5 713 641 units of recovered plasma were shipped for contract fractionation to produce PDM; 0.26/105 donations for HBV DNA and 0.14/105 for HCV RNA were reported positive. The results of five retested samples for HBV and one sample for HCV were negative. CONCLUSION The prevalence of HBV, HCV, and HIV in blood donations was extremely low. Thanks to the availability, high quality and safety of recovered plasma as a result of the improvements in the quality system at IBTO, this plasma could be used for the production of PDMPs.
Collapse
Affiliation(s)
- Sedigheh Amini-Kafiabad
- Department of Pathology, Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
| | - Ali Akbar Pourfatollah
- Department of Immunology, Faculty of Medical Science, Tarbiat Modares University, Tehran, Iran
| |
Collapse
|
|
16
|
Sarker T, Katz LM, Bloch EM, Goel R. Blood Product (Donor) Noninfectious and Infectious Testing and Modification. Clin Lab Med 2021; 41:579-598. [PMID: 34689966 DOI: 10.1016/j.cll.2021.07.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
Blood transfusion begins with safe donor selection and testing. In the United States, the blood supply and transfusion are highly regulated. Blood transfusion safety is multifaceted, whereby each of the elements of the blood safety value chain, spanning donor recruitment and qualification, to collection, blood processing, testing, transfusion practice, and posttransfusion surveillance, must be optimized to minimize risk. Pathogen inactivation is a promising approach to decrease bacterial contamination of platelets, inactivate parasites and viruses, and decrease risks associated with emerging and unidentified pathogens. This article offers an overview of blood donor infectious and noninfectious testing in the United States.
Collapse
Affiliation(s)
- Tania Sarker
- Department of Pathology and Laboratory Medicine, Center for Transfusion and Cellular Therapies, Emory University School of Medicine, Atlanta, GA 30322, USA
| | - Louis M Katz
- Mississippi Valley Regional Blood Center, Davenport, IA, USA; Carver College of Medicine, UIHC, Iowa City, IA, USA
| | - Evan M Bloch
- Department of Pathology, Transfusion Medicine, Johns Hopkins University School of Medicine, 600 North Wolfe Street/Carnegie 446 D1, Baltimore, MD 21287, USA
| | - Ruchika Goel
- Mississippi Valley Regional Blood Center, Davenport, IA, USA; Division of Hematology/Oncology, Simmons Cancer Institute at SIU SOM; Division of Transfusion Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
| |
Collapse
|
|
17
|
Aguilera A, Pereira S, Fuentes A, de Salazar A, Trastoy R, Navarro D, Picchio CA, Lazarus JV, García F. Pooling samples for hepatitis C RNA detection. Lancet Gastroenterol Hepatol 2021; 6:608-609. [PMID: 34246354 PMCID: PMC8266286 DOI: 10.1016/s2468-1253(21)00217-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/21/2021] [Revised: 06/01/2021] [Accepted: 06/02/2021] [Indexed: 11/28/2022]
Affiliation(s)
- Antonio Aguilera
- Servicio de Microbiología, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain; Departamento de Microbiología, Universidade de Santiago de Compostela, Santiago de Compostela, Spain; Instituto de Investigación Sanitaria de Santiago, Santiago de Compostela, Spain
| | - Sara Pereira
- Servicio de Microbiología, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
| | - Ana Fuentes
- Servicio de Microbiología, Hospital Universitario Clínico San Cecilio, Granada, Spain
| | - Adolfo de Salazar
- Servicio de Microbiología, Hospital Universitario Clínico San Cecilio, Granada, Spain
| | - Rocío Trastoy
- Servicio de Microbiología, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
| | - Daniel Navarro
- Servicio de Microbiología, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
| | - Camila A Picchio
- Barcelona Institute for Global Health, Hospital Clínic, University of Barcelona, Barcelona, Spain
| | - Jeffrey V Lazarus
- Barcelona Institute for Global Health, Hospital Clínic, University of Barcelona, Barcelona, Spain
| | - Federico García
- Servicio de Microbiología, Hospital Universitario Clínico San Cecilio, Granada, Spain; Instituto de Investigación Biosanitaria, Granada, Spain.
| |
Collapse
|
|
18
|
Ye X, Zhao Y, Li R, Li T, Zheng X, Xiong W, Zeng J, Xu M, Chen L. High Frequency Occult Hepatitis B Virus Infection Detected in Non-Resolved Donations Suggests the Requirement of Anti-HBc Test in Blood Donors in Southern China. Front Immunol 2021; 12:699217. [PMID: 34394093 PMCID: PMC8355616 DOI: 10.3389/fimmu.2021.699217] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/26/2021] [Accepted: 07/12/2021] [Indexed: 02/04/2023] Open
Abstract
Background Most Chinese Blood Centers adopted mini pool (MP) nucleic acid testing (NAT) for HBV screening due to high cost of Individual donation (ID) NAT, and different proportions of MP-reactive but ID-non-reactive donations (MP+/ID-, defined as non-resolved donations) have been observed during daily donor screening process. Some of these non-resolved donations are occult HBV infections (OBIs), which pose potential risk of HBV transmission if they are not deferred. This study is aimed to further analyze these non-resolved donations. Methods The non-resolved plasma samples were further analyzed by serological tests and various HBV DNA amplification assays including quantitative PCR (qPCR) and nested PCR amplifying the basic core and pre-core promoter regions (BCP/PC; 295 base pairs) and HBsAg (S) region (496 base pairs). Molecular characterizations of HBV DNA+ non-resolved samples were determined by sequencing analysis. Results Of 17,226 MPs from 103,356 seronegative blood donations, 98 MPs were detected reactive for HBV. Fifty-six out of these 98 (57.1%) reactive MPs were resolved as HBV DNA+, but the remaining 42 pools (42.9%, 252 donations) were left non-resolved with a high rate (53.2%) of anti-HBc+. Surprisingly, among 42 non-resolved MPs, 17 contained one donation identified as OBIs by alternative NAT assays. Sequence analysis on HBV DNAs extracted from these OBI donations showed some key mutations in the S region that may lead to failure in HBsAg detection and vaccine escape. Conclusion A total of 53.2% of the non-resolved donations were anti-HBc+, and OBIs were identified in 40.5% of these non-resolved pools. Therefore, non-resolved donations with anti-HBc+ might pose potential risk for HBV transmission. Our present analysis indicates that anti-HBc testing in non-resolved donations should be used to identify OBIs in order to further increase blood safety in China.
Collapse
Affiliation(s)
- Xianlin Ye
- Department of Laboratory, Shenzhen Blood Center, Shenzhen, China
| | - Yu Zhao
- Department of Laboratory, Shenzhen Blood Center, Shenzhen, China
| | - Ran Li
- Department of Laboratory, Shenzhen Blood Center, Shenzhen, China
| | - Tong Li
- Department of Laboratory, Shenzhen Blood Center, Shenzhen, China
| | - Xin Zheng
- Department of Laboratory, Shenzhen Blood Center, Shenzhen, China
| | - Wen Xiong
- Department of Laboratory, Shenzhen Blood Center, Shenzhen, China
| | - Jinfeng Zeng
- Department of Laboratory, Shenzhen Blood Center, Shenzhen, China
| | - Min Xu
- Provincial Key Laboratory for Transfusion-Transmitted Infectious Diseases, Institute of Blood Transfusion, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Chengdu, China
| | - Limin Chen
- Provincial Key Laboratory for Transfusion-Transmitted Infectious Diseases, Institute of Blood Transfusion, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Chengdu, China.,The Joint Laboratory on Transfusion-Transmitted Diseases (TTD) Between Institute of Blood Transfusion, Nanning Blood Center, Chinese Academy of Medical Sciences and Nanning Blood Center, Nanning, China.,Toronto General Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada
| |
Collapse
|
|
19
|
Alqahtani SM, A. Alsagaby S, Mir SA, Alaidarous M, Bin Dukhyil A, Alshehri B, Banawas S, Alturaiki W, Alharbi NK, Azad TA, Al Abdulmonem W. Seroprevalence of Viral Hepatitis B and C among Blood Donors in the Northern Region of Riyadh Province, Saudi Arabia. Healthcare (Basel) 2021; 9:healthcare9080934. [PMID: 34442071 PMCID: PMC8394786 DOI: 10.3390/healthcare9080934] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2021] [Revised: 07/05/2021] [Accepted: 07/14/2021] [Indexed: 12/15/2022] Open
Abstract
BACKGROUND Hepatitis B and C viral infections, which are the most common cause of liver infection worldwide, are major health issues around the globe. People with chronic hepatitis infections remain at risk of liver cirrhosis and hepatic carcinoma, while also being a risk to other diseases. These infections are highly contagious in nature, and the prevention of hepatitis B and C transmission during blood transfusion is a major challenge for healthcare workers. Although epidemiological characteristics of hepatitis B and C infections in blood donors in Saudi Arabia have been previously investigated in multiple studies, due to targeted cohorts and the vast geographical distribution of Saudi Arabia, there are a lot of missing data points, which necessitates further investigations. AIM OF THE STUDY This study aimed to determine the prevalence of hepatitis B and hepatitis C viral infections among blood donors in the northern region of Riyadh, Saudi Arabia. METHODS To determine the given objectives, a retrospective study was performed which included data gathered from serological as well as nucleic acid test (NAT) screening of blood donors. Clinical data of 3733 blood donors were collected for a period of 2 years (from January 2019 to December 2020) at the blood bank of King Khalid General Hospital and the associated blood banks and donation camps in the region. Statistical analysis of the clinical data was performed using SPSS. RESULTS The blood samples of 3733 donors were analyzed to determine the seroprevalence of hepatitis B and C among the blood donors in the northern region of Riyadh, Saudi Arabia. Among the total of 3733 blood donors, 3645 (97.65%) were men and 88 (2.36%) were women. Most of the donors were younger than 27 years of age (n = 1494). The most frequent blood group in our study was O-positive (n = 1534), and the least frequent was AB-negative (n = 29). After statistically analyzing the clinical data, we observed that 7 (0.19%), 203 (5.44%) and 260 (6.96%) donor blood samples were positive for the HBV serological markers HBsAgs, HBsAbs and HBcAbs, respectively, and 12 (0.32%) blood samples reacted positively to anti-HCV antibodies. Moreover, 10 (0.27%) and 1 (0.027%) samples were NAT-HBV positive and NAT-HCV positive, respectively. CONCLUSION In the current study, low prevalence rates of HBV and HCV were observed in the blood donors. Statistical correlations indicated that both serological tests and NATs are highly effective in screening potential blood donors for HBV and HCV, which, in turn, prevents potential transfusion-transmitted hepatitis.
Collapse
Affiliation(s)
- Saeed Mohammed Alqahtani
- Department of Medical Laboratory Sciences, College of Applied Medical Sciences, Majmaah University, Al Majmaah 11952, Saudi Arabia; (S.M.A.); (S.A.A.); (M.A.); (A.B.D.); (B.A.); (S.B.); (W.A.)
| | - Suliman A. Alsagaby
- Department of Medical Laboratory Sciences, College of Applied Medical Sciences, Majmaah University, Al Majmaah 11952, Saudi Arabia; (S.M.A.); (S.A.A.); (M.A.); (A.B.D.); (B.A.); (S.B.); (W.A.)
| | - Shabir Ahmad Mir
- Department of Medical Laboratory Sciences, College of Applied Medical Sciences, Majmaah University, Al Majmaah 11952, Saudi Arabia; (S.M.A.); (S.A.A.); (M.A.); (A.B.D.); (B.A.); (S.B.); (W.A.)
- Correspondence: ; Tel.: +966-(0)16-404-2838
| | - Mohammed Alaidarous
- Department of Medical Laboratory Sciences, College of Applied Medical Sciences, Majmaah University, Al Majmaah 11952, Saudi Arabia; (S.M.A.); (S.A.A.); (M.A.); (A.B.D.); (B.A.); (S.B.); (W.A.)
- Health and Basic Sciences Research Center, Majmaah University, Al Majmaah 11952, Saudi Arabia
| | - Abdulaziz Bin Dukhyil
- Department of Medical Laboratory Sciences, College of Applied Medical Sciences, Majmaah University, Al Majmaah 11952, Saudi Arabia; (S.M.A.); (S.A.A.); (M.A.); (A.B.D.); (B.A.); (S.B.); (W.A.)
- Health and Basic Sciences Research Center, Majmaah University, Al Majmaah 11952, Saudi Arabia
| | - Bader Alshehri
- Department of Medical Laboratory Sciences, College of Applied Medical Sciences, Majmaah University, Al Majmaah 11952, Saudi Arabia; (S.M.A.); (S.A.A.); (M.A.); (A.B.D.); (B.A.); (S.B.); (W.A.)
| | - Saeed Banawas
- Department of Medical Laboratory Sciences, College of Applied Medical Sciences, Majmaah University, Al Majmaah 11952, Saudi Arabia; (S.M.A.); (S.A.A.); (M.A.); (A.B.D.); (B.A.); (S.B.); (W.A.)
- Health and Basic Sciences Research Center, Majmaah University, Al Majmaah 11952, Saudi Arabia
- Department of Biomedical Sciences, Oregon State University, Corvallis, OR 97331, USA
| | - Wael Alturaiki
- Department of Medical Laboratory Sciences, College of Applied Medical Sciences, Majmaah University, Al Majmaah 11952, Saudi Arabia; (S.M.A.); (S.A.A.); (M.A.); (A.B.D.); (B.A.); (S.B.); (W.A.)
| | - Naif Khalaf Alharbi
- King Abdullah International Medical Research Center, Department of Infectious Disease Research, Riyadh 11451, Saudi Arabia;
- King Saud Bin Abdulaziz University for Health Sciences, Riyadh 11451, Saudi Arabia
| | - Taif Anwar Azad
- Department of Ophthalmology, College of Medicine, King Saud University, Riyadh 11451, Saudi Arabia;
| | - Waleed Al Abdulmonem
- Department of Pathology, College of Medicine, Qassim University, Buraidah 51452, Saudi Arabia;
| |
Collapse
|
|
20
|
Oeller M, Laner-Plamberger S, Krisch L, Rohde E, Strunk D, Schallmoser K. Human Platelet Lysate for Good Manufacturing Practice-Compliant Cell Production. Int J Mol Sci 2021; 22:ijms22105178. [PMID: 34068404 PMCID: PMC8153614 DOI: 10.3390/ijms22105178] [Citation(s) in RCA: 46] [Impact Index Per Article: 11.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/20/2021] [Revised: 05/07/2021] [Accepted: 05/11/2021] [Indexed: 02/06/2023] Open
Abstract
Numerous cell-based therapeutics are currently being tested in clinical trials. Human platelet lysate (HPL) is a valuable alternative to fetal bovine serum as a cell culture medium supplement for a variety of different cell types. HPL as a raw material permits animal serum-free cell propagation with highly efficient stimulation of cell proliferation, enabling humanized manufacturing of cell therapeutics within a reasonable timeframe. Providers of HPL have to consider dedicated quality issues regarding identity, purity, potency, traceability and safety. Release criteria have to be defined, characterizing the suitability of HPL batches for the support of a specific cell culture. Fresh or expired platelet concentrates from healthy blood donors are the starting material for HPL preparation, according to regulatory requirements. Pooling of individual platelet lysate units into one HPL batch can balance donor variation with regard to essential platelet-derived growth factors and cytokines. The increasingly applied pathogen reduction technologies will further increase HPL safety. In this review article, aspects and regulatory requirements of whole blood donation and details of human platelet lysate manufacturing are presented. International guidelines for raw materials are discussed, and defined quality controls, as well as release criteria for safe and GMP-compliant HPL production, are summarized.
Collapse
Affiliation(s)
- Michaela Oeller
- Department of Transfusion Medicine, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria; (M.O.); (S.L.-P.); (L.K.); (E.R.)
- Spinal Cord Injury and Tissue Regeneration Center Salzburg, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria;
| | - Sandra Laner-Plamberger
- Department of Transfusion Medicine, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria; (M.O.); (S.L.-P.); (L.K.); (E.R.)
- Spinal Cord Injury and Tissue Regeneration Center Salzburg, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria;
| | - Linda Krisch
- Department of Transfusion Medicine, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria; (M.O.); (S.L.-P.); (L.K.); (E.R.)
- Spinal Cord Injury and Tissue Regeneration Center Salzburg, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria;
- Cell Therapy Institute, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria
| | - Eva Rohde
- Department of Transfusion Medicine, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria; (M.O.); (S.L.-P.); (L.K.); (E.R.)
- Spinal Cord Injury and Tissue Regeneration Center Salzburg, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria;
- GMP Laboratory, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria
| | - Dirk Strunk
- Spinal Cord Injury and Tissue Regeneration Center Salzburg, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria;
- Cell Therapy Institute, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria
| | - Katharina Schallmoser
- Department of Transfusion Medicine, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria; (M.O.); (S.L.-P.); (L.K.); (E.R.)
- Spinal Cord Injury and Tissue Regeneration Center Salzburg, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria;
- GMP Laboratory, Paracelsus Medical University of Salzburg, 5020 Salzburg, Austria
- Correspondence:
| |
Collapse
|
|
21
|
Stanley J, Chongkolwatana V, Duong PT, Kitpoka P, Stramer SL, Dung NTT, Grimm KE, Pojanasingchod A, Suksomboonvong P, Galel SA. Detection of dengue, chikungunya, and Zika RNA in blood donors from Southeast Asia. Transfusion 2021; 61:134-143. [PMID: 33026130 PMCID: PMC7821136 DOI: 10.1111/trf.16110] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2020] [Revised: 09/11/2020] [Accepted: 09/12/2020] [Indexed: 12/11/2022]
Abstract
BACKGROUND Chikungunya (CHIKV), dengue (DENV), and Zika (ZIKV) viruses are of concern due to the potential of transfusion transmission in blood, especially in regions such as Southeast Asia where the viruses are endemic. The recent availability of nucleic acid testing (NAT) to screen blood donations on an automated platform provides the opportunity to detect potentially infectious units in asymptomatic donors. STUDY DESIGN AND METHODS Three thousand blood donations from Vietnam and 6000 from Thailand were screened with a real-time polymerase chain reaction (PCR) test (cobas CHIKV/DENV, Roche Diagnostics, Indianapolis, IN) and equal numbers on cobas Zika (Roche Diagnostics). Reactive samples were tested by alternative NAT with resolution of discordant results by heminested PCR. Throughput of simultaneous testing of the two assays on the cobas 8800 system (Roche Diagnostics) was evaluated. RESULTS In Vietnam, 9 of 3045 samples were reactive for DENV and all were confirmed, for a prevalence (with 95% confidence interval [CI]) of 0.296% (0.135-0.560). In Thailand, 2 of 6000 samples were reactive for CHIKV, 4 of 6000 for DENV, and 1 of 6005 for ZIKV, and all confirmed. The prevalence of CHIKV is 0.033% (0.004-0.120), DENV 0.067% (0.018-0.171), and ZIKV 0.017% (0.000-0.093). The overall specificity for the cobas CHIKV/DENV and cobas Zika tests was 100% (99.959-100). For the simultaneous assay testing, 960 test results were available in 7 hours and 53 minutes. CONCLUSION Detection of CHIKV, DENV, and ZIKV RNA in donor samples in Vietnam and Thailand indicate the presence of the virus in asymptomatic blood donors. The cobas 6800/8800 systems (Roche Molecular Systems, Pleasanton, CA) enable screening blood donations in endemic areas for these viruses together or separately.
Collapse
Affiliation(s)
- Jean Stanley
- Medical and Scientific AffairsRoche Molecular DiagnosticsPleasantonCaliforniaUSA
| | | | - Pham Tuan Duong
- Blood ScreeningNational Institute of Hematology and Blood TransfusionHanoiVietnam
| | - Pimpun Kitpoka
- Faculty of MedicineRamathibodi Hospital, Mahidol UniversityBangkokThailand
| | | | | | - Kacie E. Grimm
- Scientific AffairsAmerican Red CrossGaithersburgMarylandUSA
| | | | | | - Susan A. Galel
- Medical and Scientific AffairsRoche Molecular DiagnosticsPleasantonCaliforniaUSA
| |
Collapse
|
|
22
|
Lau JYC, Lee CK, Chan CP, Leung JNS, Poon CM, Lee SS. Compliance and attitudes of blood donors following transitioning from permanent to 12-month deferral of men who have sex with men in Hong Kong. Vox Sang 2020; 116:504-512. [PMID: 33196117 DOI: 10.1111/vox.13025] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/28/2020] [Revised: 10/15/2020] [Accepted: 10/15/2020] [Indexed: 11/29/2022]
Abstract
BACKGROUND AND OBJECTIVES Blood safety hinges not just on the scientific rationale for deferral period but potential donors' compliance with the prevailing policy. This study aimed to investigate donors' awareness, attitudes and compliance with the two-phased policy implementation of time-limited deferral for men who have sex with men (MSM) in Hong Kong. MATERIALS AND METHODS Three rounds of questionnaire survey were conducted between July 2017 and June 2019 covering the periods of pre-implementation (Round A), post-implementation without and with pre-donation questionnaire revision (Round B and C). Chi-square test and multivariable regression analysis were performed. RESULTS Of 3085 donors recruited, 968, 1036 and 1081 completed the surveys in Round A, B and C, respectively. The non-compliance rate of MSM remained stable at 0·6% (3/497), 0·4% (2/551) and 0·5% (3/587) among male donors in Round A, B and C, respectively. Two MSM donors from Round C complying with the prevailing policy were identified. About two-thirds (60·7%) of respondents from Round B and C were unaware of the policy change. Overall, over 80% were either neutral or positive about the change. CONCLUSION Our study showed a consistently low non-compliance rate of MSM over the three periods. The generally high level of acceptance of time-limited deferral among donors lends support to science-based policy development to protect blood safety. The identification of compliant MSM donors suggests that the 12-month deferral is effective and acceptable to MSM. With a deferral period far exceeding the window period, it is a step towards a more equitable policy.
Collapse
Affiliation(s)
- Janice Ying-Chui Lau
- Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong, Hong Kong, People's Republic of China
| | - Cheuk-Kwong Lee
- Hong Kong Red Cross Blood Transfusion Service, Hospital Authority, Hong Kong, People's Republic of China
| | - Chin-Pok Chan
- Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong, Hong Kong, People's Republic of China
| | - Jennifer Ngar-Sze Leung
- Hong Kong Red Cross Blood Transfusion Service, Hospital Authority, Hong Kong, People's Republic of China
| | - Chin-Man Poon
- Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong, Hong Kong, People's Republic of China
| | - Shui-Shan Lee
- Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong, Hong Kong, People's Republic of China
| |
Collapse
|
|
23
|
Dimech W, Vincini G, Davies K, Karakaltsas M, van Cauwalaert ND, Guichet E, Koppelman M, Cabuang L. Validation of Dried Tube Sample Format Quality Controls for the Monitoring of Viral Load and Blood Screening Assays. J Virol Methods 2020; 285:113957. [PMID: 32805272 DOI: 10.1016/j.jviromet.2020.113957] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2020] [Revised: 07/26/2020] [Accepted: 08/11/2020] [Indexed: 02/01/2023]
Abstract
HIV viral load (VL) and donor screening assays experience variation and require quaity assurance (QA). NRL sought to confirm a dried tube sample format (HIVDTS) sample type for use in quality control (QC) programs for HIV molecular testing. 50 μL of HIV supernatant at 1 × 105 copies per millilitre (copies/mL)) was dried for 48 hours at room temperature. Post-production and shipped integrity studies were undertaken. Dried HIVDTS was reconstituted in PBS buffer and tested in HIV VL (six participants) or blood screening assays (four participants). Results were entered into NRL's QC monitoring software (EDCNet™) for analysis. The mean of 224 VL results when HIVDTS QCs were tested in Biocentric HIV GENERIC Charge Virale assay was 4.54 log10 copies/mL, with the percentage coefficient of variation (CV%) ranging from 1.75 to 13.20%. The mean Ct value for HIVDTS QCs tested on Roche Cobas MPX assay results was 28.71 (range 28.33 to 29.14), with CV% ranging from 1.56 to 3.98%. The study confirms HIVDTS QCs can effectively monitor the performance of HIV molecular testing and offers a cheaper alternative to commercial QC samples that require cold-chain shipping on dry ice and UN3373 conditions.
Collapse
Affiliation(s)
- Wayne Dimech
- National Serology Reference Laboratory, 4(th)Floor Healy Building, 41 Victoria Parade, FITZROY 3065, Victoria, Australia.
| | - Giuseppe Vincini
- National Serology Reference Laboratory, 4(th)Floor Healy Building, 41 Victoria Parade, FITZROY 3065, Victoria, Australia
| | - Kylie Davies
- National Serology Reference Laboratory, 4(th)Floor Healy Building, 41 Victoria Parade, FITZROY 3065, Victoria, Australia
| | - Marina Karakaltsas
- National Serology Reference Laboratory, 4(th)Floor Healy Building, 41 Victoria Parade, FITZROY 3065, Victoria, Australia
| | | | | | | | - Liza Cabuang
- National Serology Reference Laboratory, 4(th)Floor Healy Building, 41 Victoria Parade, FITZROY 3065, Victoria, Australia
| |
Collapse
|
|
24
|
Schmidt M, Hoehl S, Berger A, Zeichhardt H, Hourfar K, Ciesek S, Seifried E. Novel multiple swab method enables high efficiency in SARS-CoV-2 screenings without loss of sensitivity for screening of a complete population. Transfusion 2020; 60:2441-2447. [PMID: 32627200 PMCID: PMC7361511 DOI: 10.1111/trf.15973] [Citation(s) in RCA: 17] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2020] [Revised: 06/19/2020] [Accepted: 06/20/2020] [Indexed: 01/18/2023]
Abstract
Background In the pandemic, testing for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) by real‐time polymerase chain reaction is one of the pillars on which countermeasures are based. Factors limiting the output of laboratories interfere with the effectiveness of public health measures. Conserving reagents by pooling samples in low‐probability settings is proposed but may cause dilution and loss of sensitivity. Blood transfusion services had experience in performance of high throughput nucleic acid testing (NAT) analysis and can support the national health system by screening of the inhabitants for SARS‐COV‐2. Methods We evaluated a new approach of a multiple‐swab method by simultaneously incubating multiple respiratory swabs in a single tube. Analytical sensitivity was constant up to a total number of 50 swabs. It was consequently applied in the testing of 50 symptomatic patients (5‐sample pools) as well as 100 asymptomatic residents of a nursing home (10‐sample pools). Results The novel method did not cause false‐negative results with nonsignificantly differing cycle threshold values between single‐swab and multiple‐swab NAT. In two routine applications, all minipools containing positive patient samples were correctly identified. Conclusions The new method enables countries to increase the total number of testing significantly. The multiple‐swab method is able to screen system relevant groups of employees frequently. The example in Germany shows that blood transfusion services can support general health systems with their experience in NAT and their high‐throughput instruments. Screening of a huge number of inhabitants is currently the only option to prevent a second infection wave and enable exit strategies in many countries.
Collapse
Affiliation(s)
- Michael Schmidt
- German Red Cross Blood Transfusion Service, Frankfurt, Germany
| | - Sebastian Hoehl
- Institute for Medical Virology, University Hospital, Goethe-University, Frankfurt, Germany
| | - Annemarie Berger
- Institute for Medical Virology, University Hospital, Goethe-University, Frankfurt, Germany
| | - Heinz Zeichhardt
- Institut fuer Qualitaetssicherung in der Virusdiagnostik - IQVD der GBD mbH, Berlin, Germany.,INSTAND Gesellschaft zur Foerderung der Qualitaetssicherung in medizinischen Laboratorien e.V., Duesseldorf, Germany.,Charité-Universitaetsmedizin, Institut fuer Virologie, Berlin, Germany
| | - Kai Hourfar
- German Red Cross Blood Transfusion Service, Frankfurt, Germany
| | - Sandra Ciesek
- Institute for Medical Virology, University Hospital, Goethe-University, Frankfurt, Germany.,Germany Centre for Infection Research (DZIF), External Partner Site, Frankfurt, Germany
| | - Erhard Seifried
- German Red Cross Blood Transfusion Service, Frankfurt, Germany
| |
Collapse
|
|
25
|
Seroprevalence of HBV, HCV and HIV-1 and Correlation with Molecular Markers among Multi-Transfused Thalassemia Patients in Western India. Mediterr J Hematol Infect Dis 2020; 12:e2020038. [PMID: 32670516 PMCID: PMC7340250 DOI: 10.4084/mjhid.2020.038] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/07/2020] [Accepted: 06/06/2020] [Indexed: 12/27/2022] Open
Abstract
Background Multitransfused β-thalassemia major patients are always at high risk of having Transfusion Transmitted Infections (TTIs). This study was aimed to determine the seroprevalence of HBsAg, Anti-HIV-1/2, and Anti-HCV among these patients and to correlate the same with NAT testing. Methods A total of 196 patients with β-thalassemia were included in the study. Patients were screened for the presence of viral markers by third-generation ELISA test as well as for viral DNA/RNA by NAT test. Results Among 196 multi-transfused Beta-thalassemia patients, the seroprevalence of anti-HCV was very high 100 (51.1%), however, anti-HIV1/2 was 6 (3.1%), and HBsAg were 3 (1.5%). Surprisingly similar patterns were observed in the prevalence of molecular markers, as HCV-RNA were 66 (33.7%) of the patients along with HIV-1 RNA were 8 (4.1%), and HBV-DNA were 5 (2.5%) patients. Overall eight (4.1%) patients were found to have coinfections, where two were positive for HBsAg/anti-HCV by ELISA along with 3 (1.5%) were positive for HBV-DNA/ HCV-RNA, 1 (0.5%) was positive for HIV-RNA/HBV-DNA, and 2 (1%) had coinfection of HIV-RNA/ HCV RNA by NAT testing Conclusion The prevalence of HCV infection among multi-transfused β-thalassemia patients is significantly higher than that of the HBV and HIV infections. This scenario should be controlled and monitored by doing regular follow-up testing schedules of such patients and also the administration of the booster dose of the HBV vaccine along with HCV treatment with antiviral DAAs.
Collapse
|
|
26
|
Wang L, Hong W, Zhu W, Lu L, Yang Z, Zhao F, Xu X, Xiong W, Wang L, Zeng J. Efficacy of early antiretroviral therapy 36 hours after HIV infection in one blood donor. Transfusion 2020; 60:1633-1638. [PMID: 32358857 DOI: 10.1111/trf.15822] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2019] [Revised: 03/22/2020] [Accepted: 03/23/2020] [Indexed: 11/28/2022]
Abstract
BACKGROUND Discrepancies can occur with the use of clinical human immunodeficiency virus (HIV) diagnostic reagents for the HIV window period (WP; time from RNA to antibody detection by diagnostic or blood screening assays). Antiretroviral therapy (ART) during acute HIV infection can impact HIV-specific antibodies, antigens, and DNA/RNA detection. In this study, an HIV WP blood donor who initiated ART was monitored, evaluating the immunological and nucleic acid testing (NAT) results for early ART and discussing the potential effects on blood safety. STUDY DESIGN AND METHODS This was a follow-up study of a HIV WP donor detected 36 hours after high-risk sexual behavior, who was subsequently treated with ART. Immunological and NAT methods were comparatively analyzed. RESULTS The 4th generation HIV serologic assays were positive at Day 11, and the 3rd generation domestic anti-HIV assay was positive at Day 33. Individual donation (ID) NAT and minipool (MP) NAT of six samples were reactive, but 12-sample MP-NAT was nonreactive. ART resulted in a slow decline of HIV RNA, but HIV DNA was still detected on Day 757. CONCLUSION After ART, ID-NAT was more sensitive than MP-NAT or serologic detection; however, HIV DNA detection was more sensitive, with DNA but not RNA persistently detectable.
Collapse
Affiliation(s)
- Lilin Wang
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Wenxu Hong
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Weigang Zhu
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Liang Lu
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Zhengrong Yang
- Shenzhen Center for Disease Control and Prevention, Shenzhen, China
| | - Fang Zhao
- Shenzhen Third People's Hospital, Shenzhen, China
| | - Xiaoxuan Xu
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Wen Xiong
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Lunan Wang
- National Center for Clinical Laboratories, Beijing Hospital, Beijing, China
| | - Jinfeng Zeng
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| |
Collapse
|
|
27
|
Ye X, Li T, Zhang R, Liu H, Zeng J, Hong W, Lu L, Zhu W, Li S, Xu M, Wu S, Chen L. Comprehensive analysis of hepatitis B virus infections in blood donors in southern China that are surface antigen positive but nucleic acid testing negative. Transfusion 2020; 60:1476-1482. [PMID: 32358842 DOI: 10.1111/trf.15824] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2019] [Revised: 03/11/2020] [Accepted: 03/13/2020] [Indexed: 02/06/2023]
Abstract
BACKGROUND Hepatitis B virus (HBV) infection is one of the major concerns for the safety of blood transfusion in high-prevalent countries such as in China. Prior studies outside of China have shown hepatitis B surface antigen (HBsAg) false-reactive rate of 0.02% to 0.04%. Similarly, false-negative HBsAg and HBV DNA results may occur in infected donors. Our study analyzed HBsAg enzyme-linked immunosorbent assay (ELISA)-reactive but NAT-negative donations in Shenzhen Blood Center, China. STUDY DESIGN AND METHODS HBsAg ELISA-positive/NAT-negative plasma samples identified from screening 101,025 donations during 2017-2018 were analyzed by molecular and serologic tests including neutralization, chemiluminescence immunoassays, and various HBV DNA amplification assays. Molecular characterizations of HBsAg-positive/NAT-negative samples were determined by quantitative polymerase chain reaction (qPCR) and nested PCR amplification of the basic core and precore promotor regions (295 base pairs) and HBsAg (S) region (496 base pairs). RESULTS Screening of 101,025 eligible blood donations identified 157 (0.16%, 95% confidence interval, 0.13%-0.18%) HBsAg ELISA-positive/NAT-negative plasma samples; of those, 71 (45.2%) were HBsAg confirmed positive by further HBsAg testing and DNA positive by molecular tests with increased sensitivity. Of the 71, all but one was antibody to hepatitis B core antigen reactive without antibody to hepatitis B surface antigen, yielding one recent (window-period) HBV infection. Of the remaining donations, 80 (51%) were not considered as HBV-infected donors, and 6 (3.8%) were interpreted as indeterminate since HBsAg results were discordant with unconfirmed HBV DNA results. In the 71 confirmed positives, HBsAg levels ranged from 0.05 to 400 IU/mL and HBV DNA from 6 to 2654 IU/mL; however, the correlation between the two was weak (R2 = 0.24). CONCLUSION Fewer than half of HBsAg ELISA-positive/NAT-negative samples were confirmed as HBsAg positive. Our study demonstrates that in highly HBV-endemic countries, assays with high sensitivity and specificity may be required.
Collapse
Affiliation(s)
- Xianlin Ye
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Tong Li
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Ruohao Zhang
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Heng Liu
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Jinfeng Zeng
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Wenxu Hong
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Liang Lu
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Weigang Zhu
- Shenzhen Blood Center, Shenzhen, Guangdong, China
| | - Shilin Li
- Provincial Key Laboratory for Transfusion-transmitted Infectious Diseases, Institute of Blood Transfusion, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Chengdu, Sichuan, China
| | - Min Xu
- Provincial Key Laboratory for Transfusion-transmitted Infectious Diseases, Institute of Blood Transfusion, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Chengdu, Sichuan, China
| | - Shaobo Wu
- Provincial Key Laboratory for Transfusion-transmitted Infectious Diseases, Institute of Blood Transfusion, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Chengdu, Sichuan, China
| | - Limin Chen
- Provincial Key Laboratory for Transfusion-transmitted Infectious Diseases, Institute of Blood Transfusion, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Chengdu, Sichuan, China.,Toronto General Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada
| |
Collapse
|
|
28
|
Grabarczyk P, Kubicka‐Russel D, Kopacz A, Liszewski G, Sulkowska E, Zwolińska P, Madaliński K, Marek M, Szabelewska M, Świątek E, Laskus T, Radkowski M. Seronegative hepatitis C virus infection in Polish blood donors-Virological characteristics of index donations and follow-up observations. J Med Virol 2020; 92:339-347. [PMID: 31670401 PMCID: PMC7003774 DOI: 10.1002/jmv.25617] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/21/2019] [Accepted: 10/22/2019] [Indexed: 12/24/2022]
Abstract
Nucleic acid testing (NAT) was implemented in Poland in 1999 for screening of plasma for fractionation and for all blood donors in 2002. To analyze seronegative NAT-positive samples representing hepatitis C virus (HCV) window-period (WP) in the years 2000 to 2016 and to determine infection outcome. We analyzed results of 17 502 739 donations screened in minipools (6-48) or individually. Index samples underwent viral load (VL) quantification, genotyping and Ag, and anti-HCV re-testing using chemiluminescence (CMIA), electrochemiluminescence (ECLIA), and fourth-generation enzyme-linked immunosorbent assay (IV EIA) assays. HCV-seronegative infections were identified in 126 donations (7.2/mln donations; 95% confidential intervals, 6.0-8.6). Frequency of NAT yields was decreasing over time. Of the initial 126 seronegative index cases 106 were retested: 32.1% were reactive in IV EIA, 11.3% in ECLIA, and 1.9% in CMIA. The lowest VL correlated with absent anti-HCV and HCV Ag, while VL was highest when the antigen was detectable and then it decreased when anti-HCV appeared at a level detectable by sensitive third generation tests while retesting. The proportion of genotype 1 was 38.9% in samples positive only for HCV RNA and 71.4% in samples that were anti-HCV reactive in re-testing. In parallel, genotype 3 frequency was 50% in the former group and 21% in the latter. NAT is an effective measure to limit HCV transmission by transfusion and IV EIA seems to have higher clinical sensitivity than ECLIA. Samples representing likely successive phases of early HCV infection were characterized by different genotype distribution probably due to very early elimination of genotype 3.
Collapse
Affiliation(s)
- Piotr Grabarczyk
- Department of VirologyInstitute of Haematology and Transfusion MedicineWarsawPoland
| | | | - Aneta Kopacz
- Department of VirologyInstitute of Haematology and Transfusion MedicineWarsawPoland
| | - Grzegorz Liszewski
- Department of VirologyInstitute of Haematology and Transfusion MedicineWarsawPoland
| | - Ewa Sulkowska
- Department of VirologyInstitute of Haematology and Transfusion MedicineWarsawPoland
| | - Paulina Zwolińska
- Department of VirologyInstitute of Haematology and Transfusion MedicineWarsawPoland
| | - Kazimierz Madaliński
- Department of VirologyNational Institute of Public Health—National Institute of HygieneWarsawPoland
| | - Maciej Marek
- Labolatory of Infectious Diseases Transmitted by Blood, Regional Blood Transfusion CenterKaliszPoland
| | - Małgorzata Szabelewska
- Department of Testing for Infectious Diseases Transmitted by TransfusionMilitary Blood Transfusion CenterWarsawPoland
| | - Ewa Świątek
- Laboratory of Infectious Diseases Serodiagnostics, Regional Blood Transfusion CenterWrocławPoland
| | - Tomasz Laskus
- Department of Adult Infectious DiseasesWarsaw Medical UniversityWarsawPoland
| | - Marek Radkowski
- Department of Immunopathology of Infectious and Parasitic DiseasesWarsaw Medical UniversityWarsawPoland
| |
Collapse
|
|
29
|
Scheiblauer H, Heiden M, Funk M, Oberle D, Kreß J, Jork C, Chudy M. Detection of hepatitis B virus infection in German blood donors 2008-2015. Vox Sang 2020; 115:152-161. [PMID: 32023664 DOI: 10.1111/vox.12890] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2019] [Revised: 01/03/2020] [Accepted: 01/07/2020] [Indexed: 12/17/2022]
Abstract
BACKGROUND AND OBJECTIVES Assessment of HBV-NAT testing compared to HBsAg and anti-HBc screening in German blood establishments for the period 2008-2015. MATERIALS AND METHODS Blood donations screened for HBsAg and anti-HBc along with HBV-NAT were evaluated. Sensitivity of HBsAg and HBV-NAT tests was compared in 30 HBV seroconversion panels and with the viral load of the NAT-only cases. Residual risk for HBV in the WP was modelled. RESULTS A total of 45 270 111 donations were evaluated. There were 29 NAT-only cases in the HBsAg-negative HBV-WP, one by ID-NAT and 28 by MP-NAT. MP-NAT, on average, showed higher sensitivity than HBsAg testing: MP-NAT-LoD of 146 IU/ml vs. 362 IU/ml HBV DNA for positive HBsAg detection (range 135-1502 IU/ml), resulting in 3·1 days (range 2·0-4·8 days) earlier HBV detection. Viral loads of the NAT-only cases confirmed the sensitivity of the HBV tests in the seroconversion study. One HBsAg-negative case was due to a new HBsAg mutant combination. There was one HBsAg-reactive only case. In addition, HBV incidence in the HBV-WP included 41 HBsAg-/HBV-NAT-positives and three HBV transmission cases. The residual risk for HBsAg was estimated to be 1:1 619 419-1 268 474 compared to 1:2 793 365-2 134 702 for MP-NAT. Within chronic HBV (HBsAg-/anti-HBc-positive and MP-NAT-negative) 70% were ID-NAT positive at low viral load (median 20 IU/ml). Among anti-HBc-only, supplementary ID-NAT detected 23 occult HBV infections. CONCLUSIONS In the HBV-WP, MP-NAT provided a higher sensitivity than HBsAg testing, obtained a considerably higher yield and reduced the risk for HBV transmission. In later HBV stages, anti-HBc screening and HBV-ID-NAT intercepted potentially infectious donations.
Collapse
Affiliation(s)
- Heinrich Scheiblauer
- Testing Laboratory for in vitro Diagnostic Medical Devices, Paul-Ehrlich-Institut, Langen, Germany
| | - Margarethe Heiden
- Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Langen, Germany
| | - Markus Funk
- Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Langen, Germany
| | - Doris Oberle
- Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Langen, Germany
| | - Julia Kreß
- Section of Molecular Virology, Paul-Ehrlich-Institut, Langen, Germany
| | - Christine Jork
- Zentralinstitut Springe, NAT Laboratory, DRK-Blutspendedienst NSTOB, Springe, Germany
| | - Michael Chudy
- Section of Molecular Virology, Paul-Ehrlich-Institut, Langen, Germany
| |
Collapse
|
|
30
|
Sánchez Ibáñez J, Vilarrodona Serrat A, Seoane Pillado T, Rodriguez Aierbe C, Villalba Montoro R, Calvo Benito J, Pevida Lopez M, Fernández Paneque S, Vuelta Lopez E, Martínez Lorenzo MJ, González Romero M, Cañizares Castellanos A, Sauleda Oliveras S. Evaluation of occult hepatitis B infection in tissue donors: a multicenter analysis in Spain. Cell Tissue Bank 2019; 20:513-526. [PMID: 31451994 DOI: 10.1007/s10561-019-09784-5] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/12/2019] [Accepted: 08/21/2019] [Indexed: 12/31/2022]
Abstract
Traditionally, when antibody to the Hepatitis B core antigen (anti-HBc) and antibody to the Hepatitis B surface antigen (anti-HBs) are positive, the donor is considered suitable. However, the literature contains cases with this profile and circulating hepatitis B virus DNA. The aim of the study is to analyze the incidence of occult hepatitis B virus infection (OBI). Retrospective data were evaluated for deceased tissue donors in ten Tissue Establishments (Spain) during 2017. The data included demographic data and the serological markers for hepatitis B that each tissue establishment performed. A total number of 1933 tissue donors were evaluated. A total of 180 donors were excluded: 6 (0.3%) with Hepatitis B surface antigen (HBs positive), and 174 in which DNA testing was not performed. Anti-HBc was positive in 175 donors (10%), in which anti-HBs was negative in 30 (17.1%) and positive in 145 (82.9%). In total, 27 donors with DNA positive (1.5%) were found, of which 3 of 117 donors (1.7%) showed anti-HBc negative and anti-HBs positive (> 10 IU/ml), 4 of 30 donors (13.3%) showed anti-HBc positive and anti-HBs negative and 20 of 145 donors (13.8%) showed both anti-HBc and anti-HBs positive. The highest probability of finding DNA occurs when anti-HBc is positive, regardless of the presence of anti-HBs. In our study, the probability of OBI was 1.5%. The classic concept that when anti-HBc and anti-HBs are positive (even with a titer of over 100 IU/ml) the donor can be accepted should, therefore, be reconsidered, and DNA testing should be mandatory.
Collapse
Affiliation(s)
- Jacinto Sánchez Ibáñez
- Cryobiology Unit - Tissue Establishment, Complejo Hospitalario Universitario de A Coruña, A Coruña University Hospital, Avenida As Xubias 84, 15006, A Coruña, Spain.
| | | | - Teresa Seoane Pillado
- Clinical Epidemiology and Biostatistics Research Group, Instituto de Investigacion Biomedica de A Coruña, A Coruña University Hospital, A Coruña, Spain
| | | | | | - Javier Calvo Benito
- Tissue Establishment, Balearic Island Blood and Tissue Bank Foundation (FBSTIB), Cell Therapy and Tissue Engineering Group (TERCIT), Balearic Islands Institute of Health Research (IdISBa), Palma de Mallorca, Spain
| | - Marta Pevida Lopez
- Tissue Establishment, Centro Comunitario de Sangre y Tejidos del Principado de Asturias, Oviedo, Spain
| | | | - Elena Vuelta Lopez
- Tissue Establishment, Establecimiento de Tejidos Humanos, Fundación Clinica San Francisco, León, Spain
| | | | | | | | | |
Collapse
|
|
31
|
Novelo-Garza B, Duque-Rodríguez J, Mejía-Domínguez AM, Rivas-González MR, Torres-Torres O. Blood safety in Mexico and a perspective on Latin America. Transfus Apher Sci 2019; 58:102661. [PMID: 31757664 DOI: 10.1016/j.transci.2019.10.003] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2019] [Revised: 10/08/2019] [Accepted: 10/16/2019] [Indexed: 12/22/2022]
Abstract
Blood safety has been of paramount concern worldwide over the last decades, and Latin America and Mexico are no exception. Factors of utmost importance include the use of highly efficient screening tests and the encouragement of voluntary donation. This review summarizes the current situation in Latin America and particularly in Mexico with respect to these key issues. Except for some specific regions, there is a lack of progress of voluntary donation in Mexico compared with other Latin American countries. A more efficient voluntary donation system could provide donors with lower prevalence of infectious agents such as human immunodeficiency, hepatitis B, and hepatitis C viruses. In Latin America, and specifically in countries such as Argentina, Brazil and Nicaragua, voluntary donation and blood safety are strongly encouraged. However, to date, in Mexico there has not been a specific blood safety project because of fragmentation of the health system model with structural differences among organisations. Although national policies are established to grant health coverages in Mexico, blood safety is still limited and outdated because of oversights in technical fields and regulations. Individual molecular biological tests for donor screening have recently been incorporated into the Mexican national regulations. Although the routine use of these tests as part of effective donor screening is still not compulsory, it is enabling a progressive improvement of blood safety.
Collapse
Affiliation(s)
- Bárbara Novelo-Garza
- Central Blood Bank, Centro Médico Nacional La Raza [La Raza National Medical Centre], Mexico City, Mexico
| | - Jorge Duque-Rodríguez
- Postgraduate Department, Faculty of Medicine and Biological Sciences, Universidad Autónoma de Chihuahua, State Blood Transfusion Centre, Chihuahua, Mexico.
| | - Ana-María Mejía-Domínguez
- Blood Bank, Instituto Nacional de Cardiología "Ignacio Chávez" ["Ignacio Chávez" National Institute of Cardiology], Mexico City, Mexico
| | - María-Rita Rivas-González
- Blood Bank, Hospital de Alta Especialidad "Centenario de la Revolución Mexicana" ["Centenary of the Mexican Revolution" Highly Specialised Hospital], Morelos, Mexico
| | - Oscar Torres-Torres
- Central Blood Bank, Centro Médico Nacional de Occidente [National Medical Centre of the West], Guadalajara, Mexico
| |
Collapse
|
|
32
|
Yasui K, Takihara Y, Matsuyama N, Kato H, Oka K, Imada K, Ueyama A, Kimura T, Hirayama F. Sensitivity and specificity of passive immune‐basophil activation test to detect allergic transfusion reactions. Transfusion 2019; 59:3308-3313. [DOI: 10.1111/trf.15542] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/28/2019] [Revised: 08/23/2019] [Accepted: 08/23/2019] [Indexed: 12/15/2022]
Affiliation(s)
- Kazuta Yasui
- Japanese Red Cross Kinki Block Blood Center Osaka Japan
| | | | | | - Hidefumi Kato
- Department of Transfusion Medicine and Cell Therapy Center Aichi Medical University Nagakute Japan
| | - Kazuhiko Oka
- Department Hematology Japanese Red Cross Osaka Hospital Osaka Japan
| | - Kazunori Imada
- Department Hematology Japanese Red Cross Osaka Hospital Osaka Japan
| | - Atsuko Ueyama
- Department of Pediatrics Rinku General Medical Center Osaka Japan
| | | | | |
Collapse
|
|
33
|
Izumi T, Sakata K, Okuzaki D, Inokuchi S, Tamura T, Motooka D, Nakamura S, Ono C, Shimokawa M, Matsuura Y, Mori M, Fukuhara T, Yoshizumi T. Characterization of human pegivirus infection in liver transplantation recipients. J Med Virol 2019; 91:2093-2100. [PMID: 31350911 DOI: 10.1002/jmv.25555] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2019] [Accepted: 07/24/2019] [Indexed: 12/23/2022]
Abstract
Approximately 2% of healthy persons are infected with human pegivirus (HPgV). HPgV is transmitted via vertical, sexual, and blood-borne routes. Recently, the association of HPgV infection with the risk of lymphoma was reported. Here, we examined the prevalence of chronic HPgV infection in liver transplantation (LT) recipients and patients with hepatectomy and the influence of HPgV infection after LT on clinical and perioperative factors. We enrolled 313 LT recipients and 187 patients with hepatectomy who received care at the Kyusyu University Hospital between May 1997 and September 2017. Of the 313 recipients and 187 patients enrolled in this study, 44 recipients (14.1%) and 2 patients (1.1%) had HPgV viremia, respectively. There was no significant association between HPgV infection and LT outcomes. Interestingly, one recipient was infected with HPgV during the peritransplant period, which was likely transmitted via blood transfusion because HPgV RNA was detected from the blood bag transfused to the recipient during LT. We reviewed the available literature on the prevalence HPgV infections in other organ-transplanted patients and whether they impacted clinical outcomes. They also had the higher prevalence of HPgV infection, while it appears to be of low or no consequences. In addition, HPgV infection induced the upregulation of interferon-stimulated gene (ISG) expression in peripheral blood mononuclear cells. LT recipients had higher HPgV viremia compared to patients with hepatectomy. Although HPgV infection was not associated with LT-related outcomes, it induced ISG expression in recipients.
Collapse
Affiliation(s)
- Takuma Izumi
- Department of Molecular Virology, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan.,Department of Surgery and Science, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan
| | - Kazuhito Sakata
- Department of Surgery and Science, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan
| | - Daisuke Okuzaki
- Genome Information Research Center, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan
| | - Shoichi Inokuchi
- Department of Surgery and Science, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan
| | - Tomokazu Tamura
- Department of Molecular Virology, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan
| | - Daisuke Motooka
- Department of Infection Metagenomics, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan
| | - Shota Nakamura
- Department of Infection Metagenomics, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan
| | - Chikako Ono
- Department of Molecular Virology, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan
| | - Masahiro Shimokawa
- Department of Surgery and Science, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan
| | - Yoshiharu Matsuura
- Department of Molecular Virology, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan
| | - Masaki Mori
- Department of Surgery and Science, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan
| | - Takasuke Fukuhara
- Department of Molecular Virology, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan
| | - Tomoharu Yoshizumi
- Department of Surgery and Science, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan
| |
Collapse
|
|
34
|
Davison KL, Gregoire Y, Germain M, Custer B, O'Brien SF, Steele WR, Pillonel J, Seed CR. Changing the deferral for men who have sex with men - an improved model to estimate HIV residual risk. Vox Sang 2019; 114:666-674. [PMID: 31373016 DOI: 10.1111/vox.12826] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2018] [Revised: 04/23/2019] [Accepted: 06/13/2019] [Indexed: 12/15/2022]
Abstract
BACKGROUND AND OBJECTIVES Eight published studies modelled the impact of changing from a lifetime to time-limited deferral for men who have sex with men (MSM); each predicted greater risk impact than has been observed. This study uses these previous efforts to develop an 'optimized' model to inform future changes to MSM deferrals. MATERIALS AND METHODS HIV residual risk was calculated using observed HIV incidence/prevalence prior to the change in MSM deferral, then with the additional MSM expected under a 12-month deferral for five compliance scenarios, and finally using data observed after implementation of the deferral. Monte Carlo simulation calculated 95% confidence intervals (CI). RESULTS The architecture of reviewed models was sound, and two were selected for combination into the optimized model. HIV risk estimated by this in the UK under MSM lifetime deferral was 0·102 (95% CI: 0·050-0·172) per million. The model predicted from a 27·8% decrease to a 47·6% increase depending upon compliance pre-implementation of the 12-month deferral. A decrease of 0·9% was observed post-implementation. For Canada, HIV risk under a 5-year deferral was 0·050 (95% CI: 0·00003-0·122) per million. Pre-implementation of the 12-month deferral, the model predicted from 30·2% decrease to 10-fold increase. A decrease of 47·0% was observed after implementation. CONCLUSION The optimized model predicted HIV risk under 12-month MSM deferral in UK and Canada would remain low, and this was confirmed post-implementation. While the model is adaptable to other deferral scenarios, improved data quality would improve precision, particularly estimates of incidence in individuals likely to donate.
Collapse
Affiliation(s)
| | - Yves Gregoire
- Medical Affairs and Innovation, Hema-Quebec, Quebec, QC, Canada
| | - Marc Germain
- Medical Affairs and Innovation, Hema-Quebec, Quebec, QC, Canada
| | - Brian Custer
- Blood Centers of the Pacific, San Francisco, CA, USA
| | - Sheila F O'Brien
- Epidemiology and Surveillance, Canadian Blood Services, Ottawa, ON, Canada
| | - Whitney R Steele
- Transmissible Disease Department, American Red Cross, Rockville, MD, USA
| | - Josiane Pillonel
- Direction des Maladies Infectieuses, Sante Publique, Saint-Maurice, France
| | - Clive R Seed
- Donor and Product Safety (DAPS) Policy Unit, Australian Red Cross Blood Service, Perth, WA, Australia
| | | |
Collapse
|
|
35
|
Fiedler SA, Oberle D, Chudy M, Scheiblauer H, Henseler O, Halbauer J, Heiden M, Funk M. Effectiveness of blood donor screening by HIV, HCV, HBV-NAT assays, as well as HBsAg and anti-HBc immunoassays in Germany (2008-2015). Vox Sang 2019; 114:443-450. [PMID: 31012114 PMCID: PMC6849742 DOI: 10.1111/vox.12770] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/27/2018] [Revised: 02/06/2019] [Accepted: 02/12/2019] [Indexed: 11/30/2022]
Abstract
BACKGROUND AND OBJECTIVES In Germany, in addition to standard blood donor screening, further mandatory tests were introduced for HCV-RNA, HIV-1-RNA and for anti-HBc. Screening for HBV-DNA is optional. This study investigates the benefits of these additional tests for the detection of HIV, HCV, and HBV infections among German blood donors. MATERIALS AND METHODS From 2008 to 2015 we collected data on blood donations exclusively testing NAT positive (NAT yield) or reactive in only one of the screening assays. Assuming a Poisson distribution, we calculated NAT yield/reactive only rates on a per donation basis (number of yield/reactive only cases divided by the number of donations tested in the period under review) with 95% confidence intervals. RESULTS Responding establishments covered 95% of the donations. We identified 20 HIV-1-NAT, 61 HCV-NAT and 29 HBV-NAT yield cases among approximately 46 million blood donations tested corresponding to 0·43 HIV-1 NAT, 1·32 HCV-NAT, and 0·64 HBV-NAT yield cases per million blood donations tested. For one HBsAg reactive only case and 23 anti-HBc reactive only cases in repeat donors, infection was confirmed by ID-NAT which translates into 0·02 and 0·55 cases per million donations tested. During the 8-year-observation period, one HIV-1, no HCV and four HBV transmissions associated with donations in the viremic pre-seroconversion window period were reported. CONCLUSION Annually, NAT screening alone detected 2·5 HIV-1, 7·6 HCV, and 3·6 HBV infectious donations; anti-HBc screening alone identified 2·9 infectious donations of repeat donors with occult HBV infection. Overall, the survey results support that the currently practiced donor HIV/HCV/HBV screening strategy in Germany does ensure a high standard of blood safety.
Collapse
Affiliation(s)
- Sarah A. Fiedler
- Safety of Medicinal Products and Medical DevicesPaul‐Ehrlich‐InstitutLangenGermany
| | - Doris Oberle
- Safety of Medicinal Products and Medical DevicesPaul‐Ehrlich‐InstitutLangenGermany
| | - Michael Chudy
- Testing Laboratory for in vitro diagnostic devicesSection of Molecular VirologyPaul‐Ehrlich‐InstitutLangenGermany
| | - Heinrich Scheiblauer
- Testing Laboratory for in vitro diagnostic devicesSection of Molecular VirologyPaul‐Ehrlich‐InstitutLangenGermany
| | - Olaf Henseler
- Section of Transfusion MedicinePaul‐Ehrlich‐InstitutLangenGermany
| | - Jochen Halbauer
- Safety of Medicinal Products and Medical DevicesPaul‐Ehrlich‐InstitutLangenGermany
| | - Margarethe Heiden
- Safety of Medicinal Products and Medical DevicesPaul‐Ehrlich‐InstitutLangenGermany
| | - Markus Funk
- Safety of Medicinal Products and Medical DevicesPaul‐Ehrlich‐InstitutLangenGermany
| |
Collapse
|
|
36
|
Stolz M, Gowland P, Tinguely C, Niederhauser C. Safe-Testing Algorithm for Individual-Donation Nucleic Acid Testing: 10 Years of Experience in a Low-Prevalence Country. Transfus Med Hemother 2019; 46:104-110. [PMID: 31191196 DOI: 10.1159/000499166] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2018] [Accepted: 02/25/2019] [Indexed: 01/28/2023] Open
Abstract
Introduction A highly sensitive and specific nucleic acid test (NAT) for the blood-borne viruses human immunodeficiency virus (HIV), hepatitis C (HCV), and hepatitis B (HBV) is essential for the safety of blood components. Since more than 2 decades, NAT screening of blood donations has become standard in developed countries that have implemented the individual-donation (ID-NAT) and mini-pool NAT (MP-NAT) approaches. With this powerful technique, confirmation of initial reactive (IR) NAT samples becomes a challenge. Different algorithms are currently in use to eliminate false reactive results. To show that the algorithm implemented in 2007, that uses repeat testing of IR samples in duplicate runs, is a safe strategy, especially in low endemic countries, data from a 10-year experience of ID-NAT were extensively analyzed when follow-up data were available. Methods From July 2007 to December 2014, the Procleix Ultrio assay on a Procleix Tigris system, and from January 2015 to December 2017, the cobas MPX on a cobas 8800 platform, were used for ID-NAT screening. All IR samples were subjected to repeat testing in duplicate independent runs. Only when both tests remained negative were the products released. Donor data from the last 10 years were investigated retrospectively, looking for the reoccurrence of a reactive result in a follow-up sample. Only those donors with at least an x + 1 donation result were included for the confirmation of a false reactive result. Results From the 1,830,657 donations tested, 2,450 samples were IR (0.13%); only 228 were repeat reactive ([RR], 18 HIV, 61 HCV, and 149 HBV samples), and 2,222 were non-RR (0.12%). Follow-up data were available from 1,267 donors (57%) for further analysis. All except one of these donors were ID-NAT-negative in all follow-up samples. The one exception was from a donor who acquired a fresh HBV infection 10 years after the IR donation (in the x + 28 donation) and subsequently seroconverted. Subsequent serological tests from all succeeding donations (x + 1, x + 2, etc.) were negative in all the other cases, proving that no seroconversion took place after the IR ID-NAT result. Conclusions The algorithm to deal with IR ID-NAT donations using duplicate repeat testing is very safe and cost-effective in low-prevalence countries. There is no unnecessary destruction of blood products, no counseling of false reactive donors, and also no need to add further complexity to the screening algorithm.
Collapse
Affiliation(s)
- Martin Stolz
- Interregional Blood Transfusion SRC, Laboratory Diagnostics, Bern, Switzerland
| | - Peter Gowland
- Interregional Blood Transfusion SRC, Laboratory Diagnostics, Bern, Switzerland
| | - Caroline Tinguely
- Interregional Blood Transfusion SRC, Laboratory Diagnostics, Bern, Switzerland
| | - Christoph Niederhauser
- Interregional Blood Transfusion SRC, Laboratory Diagnostics, Bern, Switzerland.,Institute of Infectious Disease, University of Bern, Bern, Switzerland.,Faculté de biologie et de médecine, Universite de Lausanne, Lausanne, Switzerland
| |
Collapse
|
|
37
|
Seed CR, Allain J, Lozano M, Laperche S, Gallian P, Gross S, Kwon S, Oh E, Kim J, Chua SS, Lam S, Ang AL, Tsoi W, Hewitt PE, Davison KL, Tettmar K, O'Flaherty N, Boland F, Williams P, Pomeroy L, Wendel S, Fachini R, Scuracchio P, Carminato P, Fearon M, O'Brien SF, Delage G, Kiely P, Hoad V, Matsubayashi K, Satake M, Taira R, Stramer SL, Sauleda S, Bes M, Piron M, El Ekiaby M, Vermeulen M, Levičnik Stezinar S, Nograšek P, Jarvis LM, Petrik J, Charlewood R, Flanagan P, Grabarczyk P, Kopacz A, Łętowska M, Seifried E, Schmidt M. International Forum on Occult hepatitis B infection and transfusion safety. Vox Sang 2019; 114:e1-e35. [DOI: 10.1111/vox.12743] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Affiliation(s)
| | | | | | - Syria Laperche
- Institut National de la Transfusion Sanguine Département des agents transmissibles par le sang Centre National de Référence Risques Infectieux Transfusionnels 6 rue Alexandre Cabanel Paris 75015 France
| | - Pierre Gallian
- Etablissement Français du Sang 20 Avenue du Stade de France La Plaine Saint‐Denis 93218 France
| | - Sylvie Gross
- Etablissement Français du Sang 20 Avenue du Stade de France La Plaine Saint‐Denis 93218 France
| | - So‐Yong Kwon
- Jungbu Blood Laboratory Center Korean Red Cross 22 Songchonam‐ro, Daedeok‐gu Daejeon Korea
| | - E.Y. Oh
- Jungbu Blood Laboratory Center Korean Red Cross 22 Songchonam‐ro, Daedeok‐gu Daejeon Korea
| | - J.N. Kim
- Division of Human Blood Safety Surveillance Korea Centers for Disease Control and Prevention Osong Korea
| | - Sze Sze Chua
- Health Sciences Authority Blood Services Group 11 Outram Road Singapore 169078 Singapore
| | - Sally Lam
- Health Sciences Authority Blood Services Group 11 Outram Road Singapore 169078 Singapore
| | - Ai Leen Ang
- Health Sciences Authority Blood Services Group 11 Outram Road Singapore 169078 Singapore
| | - Wai‐Chiu Tsoi
- Hong Kong Red Cross Blood Transfusion Service 15 King's Park Rise Kowloon Hong Kong China
| | | | - Katy L. Davison
- NHS Blood and Transplant Public Health England Epidemiology Unit Colindale Avenue Colindale UK
| | - Kate Tettmar
- NHS Blood and Transplant Colindale Centre Charcot Road Colindale UK
| | - Niamh O'Flaherty
- Irish Blood Transfusion Service National Blood Centre St. James's Gate Dublin 8 Ireland
| | - Fiona Boland
- Irish Blood Transfusion Service National Blood Centre St. James's Gate Dublin 8 Ireland
| | - Padraig Williams
- Irish Blood Transfusion Service National Blood Centre St. James's Gate Dublin 8 Ireland
| | - Louise Pomeroy
- Irish Blood Transfusion Service National Blood Centre St. James's Gate Dublin 8 Ireland
| | - Silvano Wendel
- Hospital Sirio Libanês Rua Adma Jafet 91 São Paulo 01308‐050 Brasil
| | - Roberta Fachini
- Hospital Sirio Libanês Rua Adma Jafet 91 São Paulo 01308‐050 Brasil
| | | | | | | | | | - Gilles Delage
- Héma Québec 4045 boul. Cote‐Vertu ville Saint Laurent QC Canada
| | - Philip Kiely
- Australian Red Cross Blood Service 100‐154 Batman Street West Melbourne VIC 3003 Australia
| | - Veronica Hoad
- Australian Red Cross Blood Service 290 Wellington Street Perth WA 6000 Australia
| | - Keiji Matsubayashi
- Central Blood Institute Blood Service Headquarters Japanese Red Cross Society 2‐1‐67 Tatsumi, Koto‐ku Tokyo Japan
| | - Masahiro Satake
- Central Blood Institute Blood Service Headquarters Japanese Red Cross Society 2‐1‐67 Tatsumi, Koto‐ku Tokyo Japan
| | - Rikizo Taira
- Technical Department Blood Service Headquarters Japanese Red Cross Society 1‐2‐1 Shibakoen, Minato‐ku Tokyo Japan
| | | | - Silvia Sauleda
- Transfusion Safety Laboratory Banc de Sang i Teixits Doctor Frederic Duran i Jorda Building, Passeig Taulat, 116 08005 Barcelona Spain
| | - Marta Bes
- Transfusion Safety Laboratory Banc de Sang i Teixits Doctor Frederic Duran i Jorda Building, Passeig Taulat, 116 08005 Barcelona Spain
| | - Maria Piron
- Transfusion Safety Laboratory Banc de Sang i Teixits Doctor Frederic Duran i Jorda Building, Passeig Taulat, 116 08005 Barcelona Spain
| | - Magdy El Ekiaby
- Shabrawishi Hospital Blood Transfusion Centre Finni Square Dokki, Giza Egypt
| | - Marion Vermeulen
- The South African National Blood Service 1 Constantia Boulevard, ConstantiaKloof Roodepoort, Gauteng South Africa
| | | | - Polona Nograšek
- Blood Transfusion Centre of Slovenia Šlajmerjeva 6 SI‐1000 Ljubljana Slovenia
| | - Lisa M. Jarvis
- Scottish National Blood Transfusion Service The Jack Copland Centre 52 Research Avenue North Edinburgh EH14 4BE UK
| | - Juraj Petrik
- Scottish National Blood Transfusion Service The Jack Copland Centre 52 Research Avenue North Edinburgh EH14 4BE UK
| | - Richard Charlewood
- New Zealand Blood Service 71 Great South Road Epsom, Auckland New Zealand
| | - Peter Flanagan
- New Zealand Blood Service 71 Great South Road Epsom, Auckland New Zealand
| | - Piotr Grabarczyk
- Department of Virology Institute of Hematology and Transfusion Medicine Gandhi Str. 14th 02 776 Warsaw Poland
| | - Aneta Kopacz
- Department of Virology Institute of Hematology and Transfusion Medicine Gandhi Str. 14th 02 776 Warsaw Poland
| | - Magdalena Łętowska
- Department of Transfusion Institute of Hematology and Transfusion Medicine Gandhi Str. 14th 02 776 Warsaw Poland
| | - Erhard Seifried
- German Red Cross Institute for Transfusion medicine and Immunohematology German Red Cross Baden‐Wuerrtemberg – Hesse Goethe University Frankfurt Sandhof Street 1 60528 Frankfurt
| | - Michael Schmidt
- German Red Cross Institute for Transfusion medicine and Immunohematology German Red Cross Baden‐Wuerrtemberg – Hesse Goethe University Frankfurt Sandhof Street 1 60528 Frankfurt
| |
Collapse
|
|
38
|
Roth WK. History and Future of Nucleic Acid Amplification Technology Blood Donor Testing. Transfus Med Hemother 2019; 46:67-75. [PMID: 31191192 PMCID: PMC6514489 DOI: 10.1159/000496749] [Citation(s) in RCA: 25] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/07/2018] [Accepted: 01/09/2019] [Indexed: 12/25/2022] Open
Abstract
The introduction of blood donor screening by virus nucleic acid amplification technology (NAT) in the mid to late 1990s was driven by the so-called AIDS and hepatitis C virus (HCV) epidemic, with thousands of recipients of infected blood products and components. Plasma fractionators were the first to introduce NAT testing besides pathogen reduction procedures, to reduce the virus transmission risk through their products. To achieve a similar safety standard, NAT was then also introduced for labile blood components. German transfusion centres were the first to start in-house NAT testing of their donations in pools of up to 96 samples for HCV, hepatitis B virus (HBV), and human immunodeficiency virus-1 (HIV-1). Years later the diagnostics industry provided commercial HCV and HIV-1 and later HBV NAT tests on automated platforms. NAT tests for HIV-2, hepatitis A virus, and Parvovirus B19 followed, again driven by transfusion centres with their in-house tests. When severe acute respiratory syndrome corona virus (SARS-CoV) and West Nile Virus emerged it was the NAT that enabled the manufacturers and transfusion centres to instantly introduce sensitive and specific screening tests. Subsequent automation including sample preparation has significantly reduced the costs and complexity of the procedure and made it affordable to middle income countries as well. Currently more than 60 million donations per year are NAT tested worldwide and the remaining residual risk of virus transmission by blood components and products could be reduced to almost zero. Automation rendered possible the reduction of pool size in conjunction with increased throughput and sensitivity. Thus, antibody and antigen testing may be dispensable in the long run, particularly in the combination of NAT testing with pathogen reduction. There are new technologies on the horizon like digital droplet PCR, next-generation sequencing, lab-on-a-chip, and digital antigen assays, which are comparably sensitive. However, each of these has limitations, either in throughput, costs, automation, time to result, specificity, or the need for NAT as an integral part of the technology. Thus, NAT is still the shortest and most efficient means to the result. Donor screening NAT also contributed significantly to our knowledge on how fast viruses replicate, and on the respective diagnostic window. In conjunction with animal and patient studies, we have learned more about the minimal infectious dose and the epidemics in the donor population.
Collapse
|
|
39
|
Prevention of transfusion-transmitted infections. Blood 2019; 133:1854-1864. [PMID: 30808637 DOI: 10.1182/blood-2018-11-833996] [Citation(s) in RCA: 151] [Impact Index Per Article: 25.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2018] [Accepted: 02/03/2019] [Indexed: 01/10/2023] Open
Abstract
Since the 1970s, introduction of serological assays targeting virus-specific antibodies and antigens has been effective in identifying blood donations infected with the classic transfusion-transmitted infectious agents (TTIs; hepatitis B virus [HBV], HIV, human T-cell lymphotropic virus types I and II, hepatitis C virus [HCV]). Subsequently, progressive implementation of nucleic acid-amplification technology (NAT) screening for HIV, HCV, and HBV has reduced the residual risk of infectious-window-period donations, such that per unit risks are <1 in 1 000 000 in the United States, other high-income countries, and in high-incidence regions performing NAT. NAT screening has emerged as the preferred option for detection of newer TTIs including West Nile virus, Zika virus (ZIKV), and Babesia microti Although there is continual need to monitor current risks due to established TTI, ongoing challenges in blood safety relate primarily to surveillance for emerging agents coupled with development of rapid response mechanisms when such agents are identified. Recent progress in development and implementation of pathogen-reduction technologies (PRTs) provide the opportunity for proactive rather than reactive response to blood-safety threats. Risk-based decision-making tools and cost-effectiveness models have proved useful to quantify infectious risks and place new interventions in context. However, as evidenced by the 2015 to 2017 ZIKV pandemic, a level of tolerable risk has yet to be defined in such a way that conflicting factors (eg, theoretical recipient risk, blood availability, cost, and commercial interests) can be reconciled. A unified approach to TTIs is needed, whereby novel tests and PRTs replace, rather than add to, existing interventions, thereby ameliorating cost and logistical burden to blood centers and hospitals.
Collapse
|
|
40
|
Cappy P, Barlet V, Lucas Q, Tinard X, Pillonel J, Gross S, Tiberghien P, Laperche S. Transfusion of HIV-infected blood products despite highly sensitive nucleic acid testing. Transfusion 2019; 59:2046-2053. [PMID: 30784073 DOI: 10.1111/trf.15203] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/29/2018] [Revised: 01/18/2019] [Accepted: 01/20/2019] [Indexed: 12/27/2022]
Abstract
BACKGROUND In France, the risk of HIV transmission by transfusion was reduced by implementing pooled nucleic acid testing (NAT) in 2001 and individual NAT in 2010. We report here the first case in France of transfusion of human immunodeficiency virus (HIV)-infected blood donated during HIV pre-ramp-up phase that tested individual NAT negative. METHODS Blood donations are screened for HIV antibodies and HIV RNA (ProcleixUltrio, Grifols; limit of detection at 95%, 23 copies/mL). When a repeat donor tests positive for HIV, a repository sample from the previous donation is tested with the Cobas Taqman HIV-1 test (CTM, Roche; limit of detection at 95%, 17 copies/mL). RESULTS In August 2017, a 57-year-old male repeat donor was screened positive for HIV antibodies and RNA (plasma viral load, 11,599 copies/mL). The previous donation had tested negative with Ultrio in March 2017 but was positive with an unquantifiable plasma viral load when tested with CTM. Sequencing showed no mismatch between Ultrio primers/probes and the target sequence. HIV transmission was excluded by lookback studies in the recipient of platelets, which had been pathogen reduced, but not in the recipient of RBCs due to premature death. CONCLUSION This case demonstrates that the risk of contaminated donations due to the early HIV infection phase going undetected by highly sensitive NAT is real but exceptional. The absence of transmission to the platelets recipient could be due to the very low viral inoculum and/or to the efficacy of the viral inactivation. This case also highlights the additional value of a systematic donation archiving and the importance of donor education and predonation selection.
Collapse
Affiliation(s)
- Pierre Cappy
- Département des Agents Transmissibles par le Sang, Centre National de Référence Risques Infectieux Transfusionnels, Institut National de la Transfusion Sanguine (INTS), Paris, France
| | - Valérie Barlet
- ETS Auvergne Rhône Alpes, Laboratoire de qualification biologique des dons Est, Etablissement Français du Sang, Metz-Tessy, France
| | - Quentin Lucas
- Département des Agents Transmissibles par le Sang, Centre National de Référence Risques Infectieux Transfusionnels, Institut National de la Transfusion Sanguine (INTS), Paris, France
| | - Xavier Tinard
- ETS grand est, Pôle des vigilances, Etablissement Français du Sang, Nancy, France
| | - Josiane Pillonel
- Département des maladies infectieuses, Santé publique France, Saint-Maurice, France
| | - Sylvie Gross
- Etablissement Français du Sang, Saint Denis, France
| | - Pierre Tiberghien
- Etablissement Français du Sang, Saint Denis, France.,Unité mixte de recherche 1098 INSERM, Université de Franche-Comté, Etablissement Français du Sang, Besançon, France
| | - Syria Laperche
- Département des Agents Transmissibles par le Sang, Centre National de Référence Risques Infectieux Transfusionnels, Institut National de la Transfusion Sanguine (INTS), Paris, France
| |
Collapse
|
|
41
|
Salles NA, Nishiya AS, Ferreira SC, Rocha VG, Mendrone-Junior A. Detection of HIV-1 infections in blood donors during the pre-seroconversion window period in São Paulo, Brazil. Rev Soc Bras Med Trop 2019; 52:e20180432. [DOI: 10.1590/0037-8682-0432-2018] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/21/2018] [Accepted: 03/27/2019] [Indexed: 11/22/2022] Open
|
|
42
|
Prediction and Prevention: Interventions to Enhance Blood Safety. BLOOD SAFETY 2019. [PMCID: PMC7120977 DOI: 10.1007/978-3-319-94436-4_1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
The transmission of infectious disease by blood transfusion has been a major problem since the middle of the twentieth century. Since about 1960, there has been a concerted and prolonged effort to reduce or eliminate this outcome; the efforts have been successful, but new challenges continue to appear, mostly in the form of emerging infectious diseases. This chapter reviews two relevant issues: the possibility of predicting microbial threats to blood safety and the interventions that may be used to reduce the risks of transfusion transmission. While there are only limited opportunities to predict relevant infections, there are effective measures to enhance blood safety. These involve appropriate selection of donors, implementation of effective tests, and development and implementation of pathogen reduction.
Collapse
|
|
43
|
Abstract
Introduction The World Health Organization (WHO) recommends that all blood transfusion services must screen donated blood for human immunodeficiency virus (HIV) one and two, hepatitis B, hepatitis C and syphilis. A mandatory screening for malaria is also warranted in malaria endemic areas. Our study aimed at analyzing the prevalence and different diagnostic methods of screening transfusion transmitted infections (TTIs) in replacement and voluntary, non-remunerated donors in the blood bank of a tertiary care hospital in Islamabad, Pakistan. Methods The cross-sectional, descriptive study was conducted on 30,470 blood donors from July 2015 to October 2017, in the blood bank of a 500-bed teaching hospital in Islamabad. Initially all blood donors were screened for HIV one, HIV two, hepatitis B and hepatitis C by serological testing. The seronegative samples were further tested by nucleic acid amplification test (NAT). Malaria was screened using immuno-chromatographic antigen-detection tests, while treponema pallidum was screened by electrochemiluminescence immunoassay to detect treponema pallidum (TP) antibodies. All infected blood and blood products were discarded and donors were contacted. The donors were deferred from blood donation according to WHO guidelines. They were also counselled and referred to the infectious diseases clinic. The collected data was analyzed on IBM's statistical package for the social sciences (SPSS) version 21. Results The results revealed that amongst the 30,470 donors, 997 (3.27%) donors were found infected with one or more TTI while 29,473 (96.73%) donors were found safe. Individuals who tested positive on serology for hepatitis B were 322 (1.06%), hepatitis C were 392 (1.29%) and HIV were 49 (0.16%). The seronegative donors were tested by NAT. NAT on seronegative samples showed that 10 (0.03%) donors tested positive for hepatitis B virus deoxyribonucleic acid, while only three (0.01%) were positive for hepatitis C ribonucleic acid. No donor was found positive for HIV by NAT testing. Syphilis testing revealed a frequency of 228 (0.75%) positive results while only five (0.02%) donors were found infected with malaria. Conclusion The results testify that standardized blood component screening can save transmission of infections through blood transfusion. They also establish the superiority of NAT screening over serological tests in decreasing the residual risk of transfusion transmitted infections.
Collapse
Affiliation(s)
- Sara A Awan
- Hematology, Shifa International Hospital, Islamabad, PAK
| | - Ayesha Junaid
- Hematology, Shifa International Hospital, Islamabad, PAK
| | - Shafain Sheikh
- Immunology, Shifa International Hospital, Islamabad, PAK
| |
Collapse
|
|
44
|
Brown KA, Hassan M. Utilizing Donors with Hepatitis C Antibody Positivity and Negative Nucleic Acid Testing. CURRENT TRANSPLANTATION REPORTS 2018. [DOI: 10.1007/s40472-018-0218-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/01/2022]
|
|
45
|
Hourfar K, Eberle J, Müller M, Micha Nübling C, Chudy M, Kress J, Gürtler L, Mayr-Wohlfart U, Schrezenmeier H, Hellmann I, Luhm J, Kraas S, Ringwald J, Gubbe K, Frank K, Karl A, Tonn T, Jaeger M, Sireis W, Seifried E, Schmidt M. Human immunodeficiency virus 1 dual-target nucleic acid technology improves blood safety: 5 years of experience of the German Red Cross blood donor service Baden-Württemberg-Hessen. Transfusion 2018; 58:2886-2893. [DOI: 10.1111/trf.14919] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2017] [Revised: 07/07/2018] [Accepted: 07/11/2018] [Indexed: 12/01/2022]
Affiliation(s)
- Kai Hourfar
- German Red Cross Blood Donor Service Baden-Württemberg-Hessen; Institute for Transfusion Medicine and Immunohematology; Frankfurt Germany
| | - Josef Eberle
- Virology, National Reference Center for Retroviruses, Faculty of Medicine; Max von Pettenkofer Institute and Gene Center, LMU München; Munich Germany
| | - Markus Müller
- German Red Cross Blood Donor Service Baden-Württemberg-Hessen; Institute for Transfusion Medicine and Immunohematology; Frankfurt Germany
| | | | | | | | - Lutz Gürtler
- Virology, National Reference Center for Retroviruses, Faculty of Medicine; Max von Pettenkofer Institute and Gene Center, LMU München; Munich Germany
| | - Uschi Mayr-Wohlfart
- Institute for Clinical Transfusion Medicine and Immunogenetics Ulm; Ulm Germany
| | | | - Inke Hellmann
- German Red Cross Blood Donor Service North-East, Institute Lütjensee; Lütjensee Germany
| | - Jürgen Luhm
- German Red Cross Blood Donor Service North-East, Institute Lütjensee; Lütjensee Germany
| | - Sabine Kraas
- German Red Cross Blood Donor Service North-East, Institute Lütjensee; Lütjensee Germany
| | - Jürgen Ringwald
- German Red Cross Blood Donor Service North-East, Institute Lütjensee; Lütjensee Germany
| | - Knut Gubbe
- German Red Cross Blood Donor Service North-East, Institute Plauen; Plauen Germany
| | - Kerstin Frank
- German Red Cross Blood Donor Service North-East, Institute Plauen; Plauen Germany
| | - Andreas Karl
- German Red Cross Blood Donor Service North-East, Institute Plauen; Plauen Germany
| | - Torsten Tonn
- German Red Cross Blood Donor Service North-East, Institute Dresden; Dresden Germany
| | - Maike Jaeger
- German Red Cross Blood Donor Service Baden-Württemberg-Hessen; Institute for Transfusion Medicine and Immunohematology; Frankfurt Germany
| | - Walid Sireis
- German Red Cross Blood Donor Service Baden-Württemberg-Hessen; Institute for Transfusion Medicine and Immunohematology; Frankfurt Germany
| | - Erhard Seifried
- German Red Cross Blood Donor Service Baden-Württemberg-Hessen; Institute for Transfusion Medicine and Immunohematology; Frankfurt Germany
| | - Michael Schmidt
- German Red Cross Blood Donor Service Baden-Württemberg-Hessen; Institute for Transfusion Medicine and Immunohematology; Frankfurt Germany
| |
Collapse
|
|
46
|
Khudur Al-Nassary MS, Mahdi BM. Study of Hepatitis C Virus Detection Assays. Ann Med Surg (Lond) 2018; 36:47-50. [PMID: 30377525 PMCID: PMC6202795 DOI: 10.1016/j.amsu.2018.10.002] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2018] [Revised: 09/26/2018] [Accepted: 10/01/2018] [Indexed: 12/14/2022] Open
Abstract
Background Hepatitis C virus is a small, enveloped, positive-sense single-stranded RNA virus that causes and liver cancer like hepatocellular carcinoma and lymphomas.Aim of the study: to assess different methods in diagnosis HCV infection. Patients and methods A retrospective study of 426 patients was admitted to Al-Kindy Teaching Hospital, Baghdad-Iraq for surgical operations or renal dialysis from January-2015 to December-2016. Their serum tested for HCV Abs by rapid immunochromatography, Enzyme Linked ImunoSorbent Assay (ELISA), and RIBA test. Results The study sample was 426 patients, their age was ranged from 15 to 65 years. Males were represented 58% and the rest were females. The serum of all samples has tested by rapid Immunochromatography test. Fifty percent of them showed positive results by this test and the rest were negative. Those fifty serum samples who were positive by Immunochromatography test were reexamined by ELISA test and showed 39out of 50 (78%) were true positive by ELISA test and the rest were negative (P = 0.0001).The positive samples by ELISA have tested by RIBA test that showed 200(80%)were true positive in males and 130(74%)were true positive in females and the rest were false positive (P = 0.0001). Conclusions Early screening of the high risk group of population by highly sensitive test is important to treat infected patients and prevent dissemination among population.
Collapse
Affiliation(s)
| | - Batool Mutar Mahdi
- Al-Kindy College of Medicine, Head of HLA Research Unit, University of Baghdad, Iraq
| |
Collapse
|
|
47
|
Kameda K, Corrêa MCDV, Cassier M. A incorporação do teste diagnóstico baseado na amplificação de ácidos nucleicos (NAT) para triagem de sangue no SUS: arranjos tecnológicos para a nacionalização do “NAT brasileiro”. ACTA ACUST UNITED AC 2018. [DOI: 10.1590/s0103-73312018280108] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022]
Abstract
Resumo Os testes de ácidos nucleicos (NAT) são ferramentas complementares aos testes sorológicos para controle da transmissão de doenças infecciosas por meio de produtos obtidos a partir do sangue. Em 2002, um decreto do Ministério da Saúde tornou obrigatória a realização do NAT por todos os bancos de sangue, medida dificultada por razões como os custos necessários para a sua implantação. Como estratégia para a sua incorporação nos bancos de sangue ligados ao SUS, um consórcio público foi criado para desenvolver uma versão local do kit. A partir de métodos de pesquisa qualitativa, os autores analisam essa iniciativa, visando esmiuçar os detalhes da “nacionalização tecnológica” de um teste diagnóstico in vitro. O artigo descreve como o consórcio compreende o kit e como cada uma das tecnologias que o compõem são obtidas e reunidas no teste brasileiro. A relevância dessa análise é identificar quais os desafios e os limites à produção de testes in vitro para doenças infecciosas no Brasil, assim como a repercussão desse tipo de iniciativa para o sistema nacional de inovação em saúde.
Collapse
Affiliation(s)
- Koichi Kameda
- École des Hautes Études en Sciences Sociales, France
| | | | | |
Collapse
|
|
48
|
Kumar A, Rajput MK, Paliwal D, Yadav A, Chhabra R, Singh S. Genotyping & diagnostic methods for hepatitis C virus: A need of low-resource countries. Indian J Med Res 2018; 147:445-455. [PMID: 30082568 PMCID: PMC6094507 DOI: 10.4103/ijmr.ijmr_1850_16] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2016] [Indexed: 02/06/2023] Open
Abstract
Hepatitis C virus (HCV) infection is a blood borne and transfusion-transmitted infection (TTI). It has emerged as one of the major health challenges worldwide. In India, around 12-18 million peoples are infected with HCV, but in terms of prevalence percentage, its looks moderate due to large population. The burden of the HCV infection increases due to lack of foolproof screening of blood and blood products before transfusion. The qualified screening and quantification of HCV play an important role in diagnosis and treatment of HCV-related diseases. If identified early, HCV infection can be managed and treated by recently available antiviral therapies with fewer side effects. However, its identification at chronic phase makes its treatment very challenging and sometimes ineffective. The drugs therapy for HCV infection treatment is also dependent on its genotype. Different genotypes of HCV differ from each other at genomic level. The RNA viruses (such as HCV) are evolving perpetually due to interaction and integration among people from different regions and countries which lead to varying therapeutic response in HCV-infected patients in different geographical regions. Therefore, proper diagnosis for infecting virus and then exact determination of genotype become important for targeted treatment. This review summarizes the general information on HCV, and methods used for its diagnosis and genotyping.
Collapse
Affiliation(s)
- Anoop Kumar
- National Institute of Biologicals, Noida, India
| | | | | | | | | | | |
Collapse
|
|
49
|
Nguyen NT, Bish EK, Aprahamian H. Sequential prevalence estimation with pooling and continuous test outcomes. Stat Med 2018; 37:2391-2426. [PMID: 29687473 DOI: 10.1002/sim.7657] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2017] [Revised: 01/17/2018] [Accepted: 02/15/2018] [Indexed: 01/02/2023]
Abstract
Prevalence estimation is crucial for controlling the spread of infections and diseases and for planning of health care services. Prevalence estimation is typically conducted via pooled, or group, testing due to limited testing budgets. We study a sequential estimation procedure that uses continuous pool readings and considers the dilution effect of pooling so as to efficiently estimate an unknown prevalence rate. Embedded into the sequential estimation procedure is an optimization model that determines the optimal pooling design (number of pools and pool sizes) under a limited testing budget, considering the trade-off between testing cost and estimation accuracy. Our numerical study indicates that the proposed sequential estimation procedure outperforms single-stage procedures, or procedures that use binary test outcomes. Further, the sequential procedure provides robust prevalence estimates in cases where the initial estimate of the unknown prevalence rate is poor, or the assumed distribution of the biomarker load in infected subjects is inaccurate. Thus, when limited and unreliable information is available about the current status of, or biomarker dynamics related to, an infection, the sequential procedure becomes an attractive estimation strategy, due to its ability to mitigate the initial bias.
Collapse
Affiliation(s)
- Ngoc T Nguyen
- Grado Department of Industrial and Systems Engineering, Virginia Tech, Blacksburg, Virginia, 24061, USA
| | - Ebru K Bish
- Grado Department of Industrial and Systems Engineering, Virginia Tech, Blacksburg, Virginia, 24061, USA
| | - Hrayer Aprahamian
- Grado Department of Industrial and Systems Engineering, Virginia Tech, Blacksburg, Virginia, 24061, USA
| |
Collapse
|
|
50
|
Niederhauser C. [Transfusion-transmitted Infections: How Useful and Costly is Testing for new Infectious Disease Pathogens?]. PRAXIS 2018; 107:521-529. [PMID: 29690842 DOI: 10.1024/1661-8157/a002967] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/08/2023]
Abstract
Zusammenfassung. Bis Anfang der 1990er Jahre waren Blutprodukte nicht selten mit HIV oder HCV kontaminiert, was zu vielen transfusionsbedingten Infektionen führte. Seither wurde die Sicherheit von Blutprodukten in Bezug auf die Infektionsübertragung mit aufwendigen Massnahmen stark erhöht. Aktuell stehen sogenannte (re)emerging-Infektionserreger im Fokus, beispielsweise West Nile-, Zika- und Hepatitis-E-Viren. Ob und wie sich neue Massnahmen, die eine Übertragung dieser Viren verhindern sollen, kosteneffizient einführen lassen, muss mit klar definierten Vorgaben abgeklärt werden. Der entsprechende Entscheid muss gemeinsam mit den involvierten Stakeholdern und auch aufgrund von Kosten-Nutzen-Überlegungen getroffen werden. Grundsätzlich gilt, dass es eine 100-prozentige Sicherheit in Bezug auf die Übertragung von Infektionserregern mit Blutprodukten nie geben wird.
Collapse
|