ESTABLISHMENT OF AN ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBs) ANTIBODY REFERENCE PANEL FOR QUALITY ASSESSMENT OF IN VITRO RAPID DIAGNOSTIC DEVICES

Abstract

Currently, numerous rapid diagnostic devices for the detection of antibodies against hepatitis B surface antigen (anti-HBs) are widely used worldwide and in Vietnam. Quality assessment of these devices requires a reference panel comprising negative and positive samples representative of different levels of assay response. According to the principles for evaluating the performance of in vitro diagnostic (IVD) devices recommended by the European Medicines Agency (EMA) and the CLSI EP12-A2 guideline for qualitative assays, the reference panel should ensure adequate representativeness and an appropriate sample size for the assessment of relevant performance characteristics.
Accordingly, the study team selected a reference panel consisting of 50 anti-HBs-negative samples and 50 anti-HBs-positive samples, with the positive samples representing three levels: high, medium, and low. A total of 150 retrospective serum samples collected from a ministerial-level scientific and technological research project on hepatitis B were screened. Screening by immunochromatographic assay and ELISA identified 52 anti-HBs-negative and 87 anti-HBs-positive samples. From these samples, the study group selected 50 anti-HBs-negative and 50 anti-HBs-positive samples to establish the reference panel. The resulting reference panel met the requirements for use in the quality assessment of rapid diagnostic devices for anti-HBs detection