Comparison of High-Throughput Fully Automated Immunoanalyzers for Detecting Hepatitis B Virus Infection

Arch Pathol Lab Med. 2020 May;144(5):612-619. doi: 10.5858/arpa.2019-0096-OA. Epub 2019 Oct 9.

Abstract

Context.—: High-throughput automated immunoanalyzers for hepatitis B virus serologic markers have been introduced but have not been compared to existing systems.

Objective.—: To compare hepatitis B surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody analyses between our Architect i2000 platform and newer high-throughput fully automated immunoanalyzers.

Design.—: From May to June 2018, a total of 932, 914, and 1055 samples tested for hepatitis B surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody, respectively, with the Architect i2000 system for routine testing in our center were tested again with Alinity i, Atellica IM, and Cobas e801 systems.

Results.—: Total concordance rates among the systems were 98.0%, 89.5%, and 93.0% for hepatitis B surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody, respectively. Cohen's κ values exceeded 0.8. The correlations between serum hepatitis B surface antibody levels quantified by all 4 systems were high (r > 0.85). The hepatitis B surface antibody averages were greater for the Alinity i, Atellica IM, and Cobas e801 than for the Architect i2000 (P < .001).

Conclusions.—: Alinity i, Atellica IM, and Cobas e801 automated immunoanalyzers performed well when compared with the existing Architect i2000 system with regard to detection of hepatitis B viral infection. However, the new systems have higher titer and positivity rates for hepatitis B surface antibody and are more sensitive. Notably, the Atellica IM has a lower positive rate for total hepatitis B core antibody than does the Architect i2000.

Publication types

  • Comparative Study

MeSH terms

  • Automation, Laboratory
  • Biomarkers / blood
  • Hepatitis B / diagnosis*
  • Hepatitis B / virology
  • Hepatitis B Antibodies / blood*
  • Hepatitis B Core Antigens / immunology*
  • Hepatitis B Surface Antigens / blood*
  • Hepatitis B virus / immunology*
  • High-Throughput Screening Assays / instrumentation
  • Humans
  • Immunoassay / instrumentation*

Substances

  • Biomarkers
  • Hepatitis B Antibodies
  • Hepatitis B Core Antigens
  • Hepatitis B Surface Antigens