Performance evaluation of a novel RapiSafe HIV Ag/Ab combi rapid test for the detection of HIV antigen and antibodies.

ABSTRACT:

Background

The detection of acute HIV infection (AHI) is vital for timely diagnosis and appropriate management, thus, in vitro diagnostic tests that accurately identify antigen and anti-bodies separately, have a short seroconversion window period, rapid turnaround time are essential. This study aimed to evaluate the analytical and clinical performance of the RapiSafe rapid test, with a particular focus on its efficacy in detecting AHI in serum samples.

Methods

Antigen sensitivity was evaluated in 1st WHO International Standard for HIV-1 p24 Antigen (NIBSC 22/230) and Reference Panel (NIBSC 16/210). Five HIV-1 seroconversion panels and one HIV-1 p24 antigen Mixed Titer Performance Panel were detected for HIV-1 p24 antigen seroconversion sensitivity evaluation. 22 treat

SUBMITTER: Wei S 

PROVIDER: S-EPMC12535964 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature