This study evaluated the clinical perfomance of the HIV Ag/Ab Diagnostic Test, designed to qualitatively detect HIV p24 antigen and antibodies to HIV-1 and HIV-2 in human serum or plasma.
Our primary goal of this clinical performance evaluation was to validate the HIV Ag/Ab Diagnostic Test, a CLIA-based test designed for the qualitative detection of HIV p24 antigen and antibodies to HIV-1 and HIV-2 in human serum or plasma. The test was evaluated in accordance with Regulation 2017/746 (IVDR) and conducted using leftover serum and plasma samples.
The HIV Ag/Ab Diagnostic Test, classified as a Class D diagnostic device, was assessed in comparison to a CE-marked reference test, using the CE-certified CLIA analyzer. The study focused on detecting three analytes: HIV p24 antigen, anti-HIV-1 antibodies, and anti-HIV-2 antibodies.
The results demonstrated the diagnostic accuracy of the HIV Ag/Ab Diagnostic Test, showing comparable sensitivity and specificity to the reference method. The kit successfully met the standards outlined for in vitro diagnostic devices under the IVDR framework, reinforcing its value as a diagnostic tool for HIV infection.
Izabela Chodara Head of Clinical Unit | IVDIn this study, the critical aspect was ensuring that the HIV Ag/Ab DiagnosticTest achieved the high diagnostic accuracy required by IVDR standards, while effectively detecting both HIV-1 and HIV-2 antibodies, as well as HIV p24 antigen, in a limited sample size.
