FDA approves Ortho’s HIV diagnostic test

US Food and Drug Administration (FDA) has given approval for the Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (Vitros HIV Combo test) launched by Ortho Clinical Diagnostics.

The test is designed to identify HIV-1 and HIV-2 antibodies (Ab). It can also detect the p24 antigen (Ag), leading to early identification of acute HIV-1 infection, compared with third-generation tests.

The Vitros test is reported to have demonstrated earlier identification of acute HIV infection in six of a total of 32 seroconversion panels used during the comparison studies.

In combination with the firm’s technologies and Vitros Systems’ features, the specificity of the new test is claimed to have been enhanced for p24 detection.

The firm assessed the clinical and technical performance of the HIV Combo test during routine use on Vitros Systems at three external testing laboratories, as well as its research and development laboratories.

Results from these studies indicated competitive sensitivity and specificity compared with an undisclosed, commercially available fourth-generation Ag/Ab test.