Performance of rapid diagnostic tests for hepatitis B surface antigen detection in serum or plasma.

Abstract Hepatitis B surface antigen (HBsAg) is a key marker for screening and laboratory diagnosis of HBV infection. Rapid diagnostic tests (RDTs) represent promising alternatives to immunoassays-based methods because they are simple, fast and cheap. These tests, therefore, represent a powerful tool for large-scale screening and diagnosis of HBV infection in the clinical setting. Performance of 6 RDTs have been assessed in a large series of serum or plasma samples(n=501) collected in France and in Cameroon. Specificity varied from 98.0% to 99.5%, while clinical sensitivity, compared to immunoassays as the reference, was excellent for all six RDTs (98.3%-99.3%). The VIKIA HBsAg and First Response HBsAg Card Test reached sensitivity  ≥99%. False-negative results were rare and mostly encompassed inactive HBsAg carriers or patients treated with nucleoside/nucleotide analogues. A number of RDTs may widely use to increase access to testing to all levels of the health care system.