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.

NAT transfusion safety virus

Journal

Vox sanguinis
ISSN: 1423-0410
Titre abrégé: Vox Sang
Pays: England
ID NLM: 0413606

Informations de publication

Date de publication:
22 Mar 2024
Historique:
revised: 19 02 2024
received: 10 01 2024
accepted: 03 03 2024
medline: 22 3 2024
pubmed: 22 3 2024
entrez: 22 3 2024
Statut: aheadofprint

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND AND OBJECTIVES OBJECTIVE
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 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 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 CONCLUSIONS
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.

Identifiants

pubmed: 38516962
doi: 10.1111/vox.13617
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.

Références

Roth WK, Busch MP, Schuller A, Ismay S, Cheng A, Seed CR, et al. International survey on NAT testing of blood donations: expanding implementation and yield from 1999 to 2009. Vox Sang. 2012;102:82–90.
Faddy H, Osiowy C, Custer B, Busch M, Stramer SL, Adesina O, et al. International review of blood donation nucleic acid amplification testing. Vox Sang. 2024. https://doi.org/10.1111/vox.13592
The World Bank Group. World Bank Country and Lending Groups. Available from: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups. Last accessed 4 Oct 2023.
Our World in Data. Available from: http://ourworldindata.org. Last accessed 2023 Oct 4.
Polaris Observatory HCV Collaborators. Global change in hepatitis C virus prevalence and cascade of care between 2015 and 2020: a modelling study. Lancet Gastroenterol Hepatol. 2022;7:396–415.
R Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2023. Available from: https://www.R-project.org/. Last accessed 19 Oct 2023.
Tanaka A, Yamagishi N, Hasegawa T, Miyakawa K, Goto N, Matsubayashi K, et al. Marked reduction in the incidence of transfusion‐transmitted hepatitis B virus infection after the introduction of antibody to hepatitis B core antigen and individual donation nucleic acid amplification screening in Japan. Transfusion. 2023;63:2083–2097.
Sauleda S, Bes M, Piron M, Ong E, Coco SB, Carrió J, et al. 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.

Auteurs

Helen M Faddy (HM)

School of Health, University of the Sunshine Coast, Petrie, Queensland, Australia.
Research and Development, Australian Red Cross Lifeblood, Brisbane, Queensland, Australia.

Carla Osiowy (C)

National Microbiology Laboratory, Public Health Agency of Canada, Manitoba, Canada.

Brian Custer (B)

Vitalant Research Institute, San Francisco, California, USA.
Department of Laboratory Medicine, University of California San Francisco, California, USA.

Michael Busch (M)

Vitalant Research Institute, San Francisco, California, USA.

Susan L Stramer (SL)

Infectious Disease Consultant, North Potomac, Maryland, USA.

Melinda M Dean (MM)

School of Health, University of the Sunshine Coast, Petrie, Queensland, Australia.
Research and Development, Australian Red Cross Lifeblood, Brisbane, Queensland, Australia.

Jessika Acutt (J)

School of Health, University of the Sunshine Coast, Petrie, Queensland, Australia.

Elvina Viennet (E)

Research and Development, Australian Red Cross Lifeblood, Brisbane, Queensland, Australia.

Thijs van de Laar (T)

Department of Donor Medicine Research, Sanquin Research, Amsterdam, The Netherlands.

Wai-Chiu Tsoi (WC)

Hong Kong Red Cross Blood Transfusion Service, Hong Kong.

Claire Styles (C)

Pathology & Clinical Governance, Australian Red Cross Lifeblood, Melbourne, Australia.

Phil Kiely (P)

Pathology & Clinical Governance, Australian Red Cross Lifeblood, Melbourne, Australia.

Angelo Margaritis (A)

Manufacturing & Logistics, Australian Red Cross Lifeblood, Melbourne, Australia.

So-Yong Kwon (SY)

Korean Red Cross Blood Services, Republic of Korea.

Yan Qiu (Y)

Beijing Red Cross Blood Centre, Beijing, China.

Xuelian Deng (X)

Dalian Blood Centre, Dalian, China.

Antoine Lewin (A)

Medical Affairs and Innovation, Héma-Québec, Canada.

Signe Winther Jørgensen (SW)

Department of Clinical Immunology, Aarhus University Hospital, Denmark.

Christian Erikstrup (C)

Department of Clinical Immunology, Aarhus University Hospital, Denmark.

David Juhl (D)

University Hospital of Schleswig-Holstein, Institute of Transfusion Medicine, Germany.

Silvia Sauleda (S)

Banc de Sang i Teixits de Catalunya, Spain.

Bernardo Armando Camacho Rodriguez (BA)

Instituto Distrital de Ciencia Biotecnología e Innovación en Salud - IDCBIS, Colombia.

Lisbeth Jennifer Catherine Soto Coral (LJC)

Instituto Distrital de Ciencia Biotecnología e Innovación en Salud - IDCBIS, Colombia.

Paula Andrea Gaviria García (PA)

Instituto Distrital de Ciencia Biotecnología e Innovación en Salud - IDCBIS, Colombia.

Sineenart Oota (S)

National Blood Centre, Thai Red Cross Society, Thailand.

Sheila F O'Brien (SF)

Canadian Blood Services, Canada.

Silvano Wendel (S)

Hospital Sírio-Libanês Blood Bank, Brazil.

Emma Castro (E)

Centro de Transfusión de la Comunidad Valenciana, Spain.

Laura Navarro Pérez (L)

Centro de Transfusión de la Comunidad Valenciana, Spain.

Heli Harvala (H)

Microbiology Services, NHS Blood and Transplant, UK.

Katy Davison (K)

NHSBT/UKHSA Epidemiology Unit, UKHSA, UK.

Claire Reynolds (C)

NHSBT/UKHSA Epidemiology Unit, NHS Blood and Transplant, UK.

Lisa Jarvis (L)

Scottish National Blood Transfusion Service, UK.

Piotr Grabarczyk (P)

Institute of Hematology and Transfusion Medicine, Warsaw, Poland.

Aneta Kopacz (A)

Institute of Hematology and Transfusion Medicine, Warsaw, Poland.

Magdalena Łętowska (M)

Institute of Hematology and Transfusion Medicine, Warsaw, Poland.

Niamh O'Flaherty (N)

Irish Blood Transfusion Service, Dublin, Ireland.

Fiona Young (F)

Irish Blood Transfusion Service, Dublin, Ireland.

Padraig Williams (P)

Irish Blood Transfusion Service, Dublin, Ireland.

Lisa Burke (L)

Irish Blood Transfusion Service, Dublin, Ireland.

Sze Sze Chua (SS)

Health Sciences Authority, Singapore.

An Muylaert (A)

Red Cross Flanders, Belgium.

Isabel Page (I)

Centro de Hemoterapia y Hemodonacion de Castilla y Leon, Spain.

Ann Jones (A)

Welsh Blood Service, UK.

Christoph Niederhauser (C)

Interregional Blood Transfusion SRC, Switzerland.
Institute for Infectious Diseases, University of Berne, Berne, Switzerland.

Marion Vermeulen (M)

The South African National Blood Service, South Africa.

Syria Laperche (S)

Etablissement Français du Sang, La Plaine Saint Denis, France.

Pierre Gallian (P)

Etablissement Français du Sang, La Plaine Saint Denis, France.

Masahiro Satake (M)

Japanese Red Cross Blood Service, Japan.

Marcelo Addas-Carvalho (M)

Blood Center of Universidade Estadual de Campinas, Unicamp, Brazil.

Sebastián Blanco (S)

Fundación Banco Central de Sangre, Argentina.

Sandra V Gallego (SV)

Fundación Banco Central de Sangre, Argentina.
Virology Institute, School of Medicine, National University of Cordoba, Argentina.

Axel Seltsam (A)

Bavarian Red Cross Blood Donation Service, Wiesentheid, Germany.

Marijke Weber-Schehl (M)

Bavarian Red Cross Blood Donation Service, Wiesentheid, Germany.

Arwa Z Al-Riyami (AZ)

Sultan Qaboos University Hospital, Sultan Qaboos University, Oman.

Khuloud Al Maamari (K)

Sultan Qaboos University Hospital, Sultan Qaboos University, Oman.

Fatma Ba Alawi (FB)

Sultan Qaboos University Hospital, Sultan Qaboos University, Oman.

Hem Chandra Pandey (HC)

Department of Transfusion Medicine, All India Institute of Medical Sciences, New Delhi, India.

Rochele Azevedo França (RA)

Regional Blood Center of Ribeirão Preto, Brazil.

Richard Charlewood (R)

New Zealand Blood Service, Auckland, New Zealand.

Classifications MeSH