Clinical performance of Determine HBsAg 2 rapid test for Hepatitis B detection.
HBsAg
Hepatitis B surface antigen
lateral flow
point of care
rapid test
Journal
Journal of medical virology
ISSN: 1096-9071
Titre abrégé: J Med Virol
Pays: United States
ID NLM: 7705876
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
revised:
06
04
2020
received:
29
01
2020
accepted:
07
04
2020
medline:
10
4
2020
pubmed:
10
4
2020
entrez:
10
4
2020
Statut:
ppublish
Résumé
Hepatitis B virus (HBV) infection is estimated to affect 292 million people worldwide, 90% of them are unaware of their HBV status. The Determine HBsAg 2 (Alere Medical Co, Ltd Chiba Japan [Now Abbott]) is a rapid test that meets European Union (EU) regulatory requirements for Hepatitis B surface antigen 2 (HBsAg) analytical sensitivity, detecting the 0.1 IU/mL World Health Organization (WHO) International HBsAg Standard. This prospective, multicentre study was conducted to establish its clinical performance. 351 evaluable subjects were enrolled, 145 HBsAg-positive. The fingerstick whole blood sensitivity and specificity were 97.2% and 98.5% (15' reading, reference assay cut-off 0.05 IU/mL), sensitivity increasing to 97.9% with the prespecified cut-off 0.13 IU/mL (EU regulations). The venous whole blood, serum and plasma sensitivity was 97.2%, 97.9%, and 98.6%, respectively (15' reading); reaching 99%, 99.5% and 100% specificity. A testing algorithm following up an initial positive fingerstick test result with plasma/serum test demonstrates 100% specificity. The Determine HBsAg 2 test gives 15-minute results with high sensitivity and specificity, making it an ideal tool for point-of-care testing, with the potential to enable large-scale population-wide screening to reach the WHO HBV diagnostic targets. The evaluated test improves the existing methods as most of the reviewed rapid tests do not meet the EU regulatory requirements of sensitivity.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
3403-3411Subventions
Organisme : Abbott Diagnostics Medical Co., Ltd. Chiba Japan (now Abbott)
Informations de copyright
© 2020 The Authors. Journal of Medical Virology Published by Wiley Periodicals, Inc.
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