Do we need an 'in-house' neutralization assay for confirmation of hepatitis B surface antigen? Answers from a tertiary care hospital in India

Journal of Gastroenterology and Hepatology
Gnanadurai J FletcherPriya Abraham

Abstract

Hepatitis B surface antigen (HBsAg) is an important serological marker for diagnosis of hepatitis B virus (HBV) infection. Commercial kits for detection of HBsAg emphasize confirmation by neutralization assays. In this study, we have standardized an 'in-house' neutralization test for HBsAg confirmation. Among 6684 HBsAg-positive samples, 615 were subjected to an 'in-house' HBsAg neutralization test (NT). Of these, 91 (100%) high-reactive samples (optical density [OD] 1.000-3.000) and 286 (93%) of 289 low-reactive samples (OD < 1.000) were neutralized, and 235 (100%) grey-zone reactive samples were 'in-house' NT negative. Eighty-four samples of varying reactivities that were tested by the 'in-house' NT were compared with a commercial NT (AxSYM, Abbott). The 'in-house' NT showed an excellent agreement (kappa = 0.83, P < 0.001) with the commercial confirmatory assay. The sensitivity, specificity, positive and negative predictive values were 90%, 94%, 96% and 87%, respectively. The enzyme immunoassay-based 'in-house' HBsAg neutralization assay is a feasible alternative to the commercial HBsAg confirmatory assay. This technique is easily adaptable, cost-effective and reliable for the confirmation of HBsAg in a low resource setting, ...Continue Reading

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Citations

Oct 30, 2016·Journal of Clinical Laboratory Analysis·Gnanadurai John FletcherPriya Abraham
Oct 21, 2015·World Journal of Hepatology·Mallika GhoshMalay Kumar Saha

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