Performance of a new rapid test for the detection of hepatitis B surface antigen in various patient populations

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
Stéphane ChevaliezJean-Michel Pawlotsky

Abstract

Rapid diagnostic tests (RDT) have been developed for the detection of hepatitis B surface antigen (HBsAg). They represent a promising alternative to enzyme immunoassays and a powerful tool for large-scale screening and diagnosis of HBV infection, especially in regions without easy access to serological and molecular testing. The aims of the present study were to evaluate the characteristics and clinical performance of a new CE-marked HBsAg RDT, DRW-HBsAg v2.0 assay (Diagnostics for the Real World™, Ltd., USA), in various patient populations, including those chronically infected with HBV, patients with severe acute hepatitis of unknown origin and pregnant women with unknown HBV serological status at delivery. The lower limit of detection of the assay, evaluated in 21 clinical samples, ranged from 0.30 ± 0.07 to 0.97 ± 0.26 international units/mL (using Abbott Architect as a reference), depending on the HBV genotype. The assay tested positive in 100% of patients with chronic hepatitis B, 96.3% of HBsAg-positive acute hepatitis patients, and 95.2% of HBsAg-positive pregnant women. Its specificity was 98.8% in HBsAg-negative patients, 98.7% in HBsAg-negative patients with acute hepatitis of unknown origin and 97.8% in HBsAg-negativ...Continue Reading

References

Dec 24, 1998·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·C PichoudF Zoulim
Dec 22, 2007·Journal of Hepatology·Giovanna FattovichFrancesco Donato
Aug 15, 2008·Journal of Clinical Microbiology·Yu-Huei LinHelen H Lee
Dec 10, 2008·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Coralie PallierJean-Michel Pawlotsky
Apr 17, 2009·Journal of Clinical Microbiology·Stéphane ChevaliezJean-Michel Pawlotsky
Jan 29, 2011·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Karsten WursthornHeiner Wedemeyer
May 20, 2011·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Milan J SonneveldHarry L A Janssen

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Citations

Jan 29, 2016·Bulletin de la Société de pathologie exotique·K XaydalasoukY Buisson
Oct 26, 2016·Nature Reviews. Gastroenterology & Hepatology·Jean-Pierre Allain, Ohene Opare-Sem
Sep 18, 2015·Journal of Clinical Microbiology·Annabelle Servant-DelmasSyria Laperche
Sep 17, 2016·F1000Research·Slim Fourati, Jean-Michel Pawlotsky
Apr 10, 2020·Journal of Medical Virology·Ana AvellonPatrick T Kennedy
Jul 6, 2019·Annals of Global Health·James S LeathersJose D Debes
Mar 27, 2020·Frontiers in Microbiology·Edouard TuaillonPhilippe Van de Perre
Oct 8, 2020·Cells·Yinzong XiaoJessica Howell
Nov 26, 2018·Gastroenterology·Carla S CoffinNorah A Terrault

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