The FDA approved Ortho Clinical Diagnostics’ Vitros fourth-generation HIV combination test, which detects both HIV-1 and HIV-2 antibodies and the p24 antigen, which the company says allows it to detect acute HIV-1 infections earlier than previous generations.
The approval includes the Vitros Immunodiagnostic Products HIV combo reagent pack and calibrator, for use on Ortho’s Vitros 5600 in vitro diagnostic system. The combo test has not been approved in the U.S. for use on Vitros ECi/ECiQ systems.
“Ortho is committed to expanding its assay menu to meet current guidelines and testing needs,” Jennifer Paine, Ortho’s chief product portfolio and QRC officer, said in a statement.
The company cited statistics from the World Health Organization estimating that 37 million people are living with HIV worldwide, with early detection and antiretroviral treatment vital to preventing new infections.
Clinical and technical performance was evaluated at three testing laboratories in the U.S. and at Ortho's R&D laboratories, the company said, with results confirming “competitive sensitivity and specificity when compared to a leading commercially available fourth-generation test,” according to the FDA’s instructions for use (PDF).
Assay sensitivity was evaluated on seroconversion panels, with the Vitros test showing earlier detection of acute HIV infection in six of 32 panels, as well as agreement in 25 panels, the company said.