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

SUBMITTER: Nasrallah GK 

PROVIDER: S-EPMC11773256 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature