Two independent studies were conducted to evaluate performance of two HBsAg immunoassay products performed on the Abbott ARCHITECT and Bayer ADVIA Centaur immunoassay analyzers. One was a retrospective study of 484 stored samples and the second was a prospective study of 349 samples from random population. In the process of the evaluation, a number of discordant samples from HBsAg-positive patients were found which led to the discovery of a number of HBsAg mutants in the general Australian population. Following viral DNA sequencing, these were identified as HBsAg escape mutants. Whilst the existence of HBsAg mutants has been well documented in various regions of the world, this is surprising in an area of low endemicity and demonstrates the necessity of an HBsAg assay to detect mutants reliably in a diagnostic situation where HBsAg is used as the only marker to detect an HBV infection. These studies demonstrate the ability of the Abbott ARCHITECT and AxSYM HBsAg immunoassays to detect these HBsAg mutations which were not detected by the Bayer ADVIA Centaur.
(c) 2007 Wiley-Liss, Inc.