Comparison of the technical and clinical performance of the Elecsys® HBsAg II assay with the Architect®, AxSym®, and Advia® Centaur HBsAg screening assays

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.

Correlation between the Elecsys HBsAg II assay and the Architect assay for the quantification of hepatitis B surface antigen (HBsAg) in the serum

“…15,16,21 More recently Bonino et al demonstrated the Elecsys HBsAg II assay can be also used for reliable and sensitive determination of HBsAg serum levels with good correlation, 17 findings which are supported and extended by the current study. The robust nature of the correlation between the two assays may reflect similarities in the epitopes targeted by the anti-HBs antibodies used, as differences in target epitope are an important cause of differences in performance between assays, particularly with regard to HBV mutant detection.…”

“…15,16 Recently the Elecsys HBsAg II assay has also been used to determine HBsAg levels in patients with CHB. 17 …”

Comparison of the elecsys HBsAg II assay and the architect assay for quantification of hepatitis B surface antigen in chronic hepatitis B patients

“…Recent studies indicate that HBsAg quantification might be a useful complement to HBV DNA quantification for clinical assessment and treatment monitoring in patients with chronic HBV infection. [13,14] Recent studies [15][16][17] and our study showed that HBsAg levels measured by the Roche Elecsys HBsAg II assay correlate well with those obtained using the established Abbott Architect assay. The Elecsys HBsAg II assay provides a reliable method for HBsAg quantitation in treatment-naïve and on-treatment patients.…”

Comparison of Chemiluminescence Microparticle Immunoassay and Electrochemiluminescence Immunoassay for Detection of HBsAg

“…In a recent study, in which the elecsys hBsag 2 assay was also compared with architect hBsag assay, demonstrated equivalent sensitivity and specificity to architect hBsag assay (14).…”