Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Mar 15:39:e00390.
doi: 10.1016/j.plabm.2024.e00390. eCollection 2024 Mar.

Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer

Benoit Visseaux  1 , Jérémie Gautier  2 , Françoise Le Boulaire  2 , Catherine Coignard  3 , Claire Vincent  4 , Sandrine Gréaume  5 , Isabelle Voisin  5 , Veronique Lemée  6 , Jean-Christophe Plantier  6 , Yves-Edouard Herpe  7 , Etienne Brochot  8 , Stephanie Bord  9 , Marc Turini  9 , Vanessa Roulet  10 , Juliane Hey  10
Affiliations

Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer

Benoit Visseaux et al. Pract Lab Med. .

Abstract

Introduction: This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.).

Materials and methods: Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated.

Results: A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients' samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19-100.0) and 99.92% (99.82-99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21-100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19-100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss.

Conclusion: Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples.

Keywords: Analytical performances; Chemiluminescence immunoassay; Clinical performances; HBsAg; Hepatitis B infection.

PubMed Disclaimer

Conflict of interest statement

B.V., J.G., F.B., C.C., C.V., S.G., I.V., V.L., J-C.P., Y-E.H., E.B. declare no conflicts of interest, none of them received personal fees from Beckman Coulter and all are employees of institutions or companies paid by Beckman Coulter to perform this study. V.R., J.H., S.B. and M.T. are employees of Beckman Coulter.

Figures

Fig. 1
Fig. 1
Flow chart of the study.
Fig. 2
Fig. 2
WHO 3rd International Standard HBsAg analytical sensitivity of the Access HBsAg assay.
See this image and copyright information in PMC

References

    1. Hepatitis B n.d. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b (accessed April 25, 2023).
    1. Schweitzer A., Horn J., Mikolajczyk R.T., Krause G., Ott J.J. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015;386:1546–1555. doi: 10.1016/S0140-6736(15)61412-X. - DOI - PubMed
    1. Nguyen M.H., Wong G., Gane E., Kao J.-H., Dusheiko G. Hepatitis B virus: advances in prevention, diagnosis, and therapy. Clin. Microbiol. Rev. 2020;33 doi: 10.1128/CMR.00046-19. - DOI - PMC - PubMed
    1. Ganem D., Prince A.M. Hepatitis B virus infection--natural history and clinical consequences. N. Engl. J. Med. 2004;350:1118–1129. doi: 10.1056/NEJMra031087. - DOI - PubMed
    1. European Association for the Study of the Liver EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J. Hepatol. 2017;67:370–398. doi: 10.1016/j.jhep.2017.03.021. - DOI - PubMed

LinkOut - more resources