Premium
Do we need an ‘in‐house’ neutralization assay for confirmation of hepatitis B surface antigen? Answers from a tertiary care hospital in India
Author(s) -
Fletcher Gnanadurai J,
Gnanamony Manu,
David Joel,
Ismail Ashrafali M,
Subramani Thenmozhi,
Abraham Priya
Publication year - 2010
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.2009.06088.x
Subject(s) - hbsag , medicine , immunoassay , serology , neutralization , hepatitis b virus , virology , hepatitis b , antigen , immunology , virus , antibody
Background and Aims: 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. Methods: 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). Results: The ‘in‐house’ NT showed an excellent agreement ( κ = 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. Conclusion: 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, enhancing the overall quality of HBsAg screening.