Comparison of the technical and clinical performance of the

liver411

Elecsys HBsAg II assaywith the Architect, AxSym,  and Advia Centaur HBsAg screening assays.

J Med Virol. 2010 May;82(5):755-62.


Louisirirotchanakul S, Khupulsup K, Akraekthalin S, Chan KP, Saw S, Aw TC, Cho
DH, Shin MG, Lim J.

Siriraj Hospital, Bangkok, Thailand. [email protected]

Abstract
South East Asia has some of the highest prevalence rates of hepatitis B virus
(HBV) infection (>or=8%) in the world, and the emergence of hepatitis B
surface antigen (HBsAg) mutant strains is a growing problem. Assays with the
highest levels of sensitivity, including mutant detection, should be used for
routine HBsAg screening. In this large multicenter study, the clinical and
technical performance of the fully automated Elecsys HBsAg II assay was
compared with the Architect, AxSYM, and Advia Centaur HBsAg assays for HBsAg
screening. Nine laboratories (three each from Thailand, Korea, and Singapore)
compared the Elecsys HBsAg II assay with their routine HBsAg screening assay
against a range of stored and routine clinical samples, including recombinant
mutants. The Elecsys HBsAg II assay demonstrated equivalent sensitivity and
specificity to the Architect HBsAg assay. However, the Elecsys HBsAg II assay
recognized a native mutant sample (L94S, L97V, L98V, T123A) that the Architect
HBsAg assay failed to detect. The AxSYM and Advia Centaur HBsAg assays
appeared less sensitive for the detection of early HBV infection and also
failed to detect some of the recombinant mutant strains. There was almost
complete agreement between the Elecsys HBsAg II assay and comparator assays
with respect to routine serum samples. The results of this study demonstrate
that the Elecsys HBsAg II assay is a highly sensitive and specific screening
assay for HBsAg and detects reliably the most important and clinically
relevant HBV mutants and genotypes. It is suitable for routine HBsAg screening
in Asia.

(c) 2010 Wiley-Liss, Inc.
PMID: 20336717 [PubMed - indexed for MEDLINE]



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