Mindray CL-900i assay: An effective assay for hepatitis B surface antigen screening with superior specificity

Abstract

Objectives

The chemiluminescence immunoassay automated Abbott ARCHITECT hepatitis B surface antigen (HBsAg) screening assay is globally recognized for its superior sensitivity but notably low specificity. This mandates positive results confirmation by another confirmatory assay, such as the widely used Abbott ARCHITECT HBsAg neutralizing assay. This study aimed to evaluate the performance of the new chemiluminescence immunoassay, Mindray CL-900i HBsAg screening assay in comparison to the ARCHITECT neutralizing/confirmatory assay.

Methods

A total of 200 archived HBsAg-positive and -negative samples by ARCHITECT screening were selected for this study. These samples were classified as follows: true positive (n = 39): positive by ARCHITECT screening and confirmatory assays, true negative (n = 144): negative by ARCHITECT screening and confirmatory assays, and false positive (n = 17): positive by ARCHITECT screening but negative by confirmatory assay. All samples were retested using the Mindray CL-900i HBsAg screening assay.

Results

Compared with ARCHITECT confirmatory assay, the Mindray HBsAg CL-900i demonstrated perfect agreement with the confirmatory assay, as indicated by a Cohen κ value of 0.98 (0.95-1.02). Mindray CL-900i exhibited a sensitivity of 97%, positive predictive value of 100%, and negative predictive value of 99%. The specificity was 100% because none of the true-negative and false-positive results were identified as positive.

Conclusions

Mindray CL-900i could offer a cost-effective alternative for HBsAg screening, boasting perfect specificity and overcoming the limitations of current automated assays.