Comparison of high-throughput fully automated immunoanalyzers for detecting hepatitis B virus infection

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 j 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.