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

Wursthorn, Karsten; Jaroszewicz, Jerzy; Zacher, Behrend J.; Darnedde, M.; Raupach, R.; Mederacke, Ingmar; Cornberg, Markus; Manns, Michael P.; Wedemeyer, Heiner

doi:10.1016/j.jcv.2010.12.008

Cited by 78 publications

(65 citation statements)

References 26 publications

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“…Our study confirms previous results using a research protocol for the quantification of HBsAg based on the qualitative Elecsys HBsAg II assay that also correlated well with the Architect assay (21,26). In the current study we have demonstrated that the use of this assay under fully automated conditions with onboard dilution reliably determines serum HBsAg levels in routine samples from HBsAg carriers in different phases of HBV infection, including patients with HBeAg-positive and -negative CHB, and across all genotypes.…”

Section: Discussionsupporting

confidence: 89%

Multicenter Evaluation of the Elecsys Hepatitis B Surface Antigen Quantitative Assay

Zacher

Moriconi

Bowden

et al. 2011

Clin Vaccine Immunol

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Section: Discussionsupporting

confidence: 89%

Multicenter Evaluation of the Elecsys Hepatitis B Surface Antigen Quantitative Assay

Zacher

Moriconi

Bowden

et al. 2011

Clin Vaccine Immunol

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“…For the quantitative measurement of HBsAg, two platforms are mostly used for the quantification of HBsAg: the Abbott Architect (Abbott Diagnostics, Abbott Park, IL) and the Elecsys HBsAg II (Roche Diagnostics GmbH, Mannheim, Germany) (35,36). With respect to MUPIQHs, these platforms were tested for their ability to detect an array of HBsAg mutants (23,28,29,37), and both were able to detect most of the mutant HBsAg (28).…”

Section: Discussionmentioning

confidence: 99%

Analysis of Mutations in theSGene of Hepatitis B Virus Strains in Patients with Chronic Infection by Online Bioinformatics Tools

2013

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Hepatitis B virus (HBV) genomes show a high rate of mutations. This can lead to a variety of amino acid changes in the surface and polymerase genes, causing changes in viral protein conformation that can result in diminished antibody binding or decreased secretion of surface antigen (HBsAg). HBV monitoring increasingly relies on HBsAg detection and quantification, and therefore epidemiological data on HBsAg mutations are needed. We therefore analyzed the frequency of HBsAg mutations possibly influencing the quantification of HBsAg (MUPIQHs) in an unselected patient collective. To this end, we determined the HBV surface and polymerase gene sequences of an unselected patient collective of 237 individuals chronically infected with HBV and analyzed the MUPIQHs in these sequences using three different online HBV sequence analysis tools. We found that 17 or 34% of the patients, depending on the online interpretation algorithm used, harbored MUPIQHs and that MUPIQHs were not significantly associated with the duration of disease, treatment, or HBV genotype. Thus, this study shows that a substantial amount of HBV sequences derived from unselected patients chronically infected with HBV carry MUPIQHs, and therefore the reliability of routine quantitative and qualitative HBsAg tests needs to be reevaluated. The S open reading frame (ORF), which codes for the hepatitis B surface protein (HBsAg), is overlapped by the polymerase (P) gene. Therefore, mutations in the polymerase gene associated with drug resistance can result in changes in the HBV surface protein (4-7). These, and mutations introduced in the S ORF by other mechanisms, can influence virion secretion (3). They can also reduce binding of HBsAg to anti-HbS antibodies (8), particularly when they occur in the so-called "a" determinant in the major hydrophilic loop (MHL) region of the HBsAg, which is the major antibody neutralization determinant of HBsAg (9). Because the interaction between HBsAg and anti-HbS antibodies is also the basis for routine HBV diagnosis and therapy monitoring by quantitative and qualitative detection of HBsAg (1, 10), changes in HBsAg influencing the interaction with antibodies or secretion of virions might have an impact on the results obtained by these diagnostic assays. This is especially relevant since HBsAg quantitative measurements are now discussed as a predictor to guide treatment decisions (11,12).Based on viral genome sequence variability, eight HBV genotypes have been defined by specific mutations and a divergence of Ͼ8% in the whole genome, and they have been labeled A to H (13). The clinical impact of the virus genotype in regard to treatment response, to viral mutation patterns associated with drug resistance, and to MHL mutations is not entirely clear (10).For the rapid online genetic interpretation of HBV sequence data, three internet tools are available free of cost: HIV-grade HBV drug resistance interpretation (DRI), (14), Geno2pheno [HBV] (G2P) (15), and Stanford HBVseq (STAN) (16). All three of these programs have thus f...

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“…This phenomenon was observed in all of the comparisons from a previous study and is probably due to the complexity of the assays (26). For the three assays, the intra-and interassay coefficients of variance (CV) were larger using samples with lower HBsAg levels than using samples with higher levels.…”

Section: Discussionmentioning

confidence: 67%

“…Several studies have compared the accuracy of these two assays for HBsAg quantification and found that the Elecsys assay is as reliable as the Architect assay (25,26). However, comparisons of these assays according to the various phases of HBV infection were limited by the small number of samples (26).…”

Section: Discussionmentioning

confidence: 99%

Comparison of Three Luminescent Immunoassays for Hepatitis B Virus Surface Antigen Quantification during the Natural History of Chronic Hepatitis B Virus Infection

Cheng

Song

Fang

et al. 2014

Clin. Vaccine Immunol.

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bHepatitis B surface antigen (HBsAg) quantification has garnered attention because of its high predictive value in determining treatment responses. The HBsAg quantification assays, such as Architect and Elecsys, are commercially available, and more assays are in development. We aimed to compare the results of the Architect and Elecsys assays with those of a new assay, WTultra. The WTultra HBsAg assay is a sandwich chemiluminescent microplate enzyme immunoassay and provides an alternative choice which is more cost-effective and potentially applicable in developing or resource-constrained countries and areas. A total of 411 serum samples were collected from patients during various phases of chronic hepatitis B (CHB) infection. The samples were assessed using the three assays, and the results were compared and analyzed. Since the discovery of the hepatitis B surface antigen (HBsAg) by Blumberg in 1965, HBsAg detection has been the leading hallmark for diagnosing an HBV infection (2). HBsAg persistence longer than 6 months is the key diagnostic criterion for chronic hepatitis B (CHB) infection (3). HBsAg seroclearance reflects the immunological control of the infection and confers an excellent prognosis in the absence of preexisting cirrhosis or concurrent infections with other viruses (3-5).HBsAg quantification assays have been available for several years; however, the clinical application of HBsAg quantification has recently drawn attention. Several studies initially demonstrated an association between the levels of HBsAg and the levels of covalently closed circular (ccc) DNA, the template for viral replication inside the nuclei of hepatocytes (6, 7). Subsequently, serum HBsAg levels were hypothesized to be a marker of an immunological response to therapy, independent of the virological response detected from HBV DNA levels. Recently, evidence has suggested that the HBsAg levels change during the natural course of chronic HBV infection (8, 9), and a rapid decline in HBsAg levels indicates a strong response to therapy, regardless of the treatment approach. Monitoring HBsAg levels can help identify nonresponders to therapy (peginterferon [PEG-IFN] or nucleoside analogues) and determine the best management strategy for many patients (10-15).Currently, the most widely used assay for HBsAg quantification is the Architect assay (16), followed by the Elecsys platform. These assays are fully automatic, based on microparticle and automated large-scale instruments. The WTultra HBsAg assay is a novel chemiluminescent microplate enzyme immunoassay (CLEIA) that requires manual dilution and operation, and the assay cost is much lower, which is a potential requirement in some developing countries and areas. The HBsAg level varies greatly during the natural phases of HBV infection, and the Architect assay has been proven to be reliable in various scenarios; however, other assays have not been fully evaluated in each natural phase, highly limiting their clinical usage. The aim of this study was to compare these three assays for ...

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

Cited by 78 publications

References 26 publications

Multicenter Evaluation of the Elecsys Hepatitis B Surface Antigen Quantitative Assay

Multicenter Evaluation of the Elecsys Hepatitis B Surface Antigen Quantitative Assay

Analysis of Mutations in theSGene of Hepatitis B Virus Strains in Patients with Chronic Infection by Online Bioinformatics Tools

Comparison of Three Luminescent Immunoassays for Hepatitis B Virus Surface Antigen Quantification during the Natural History of Chronic Hepatitis B Virus Infection

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