US FDA okays HIV combo reagent packJanuary 14, 2019
Ortho Clinical Diagnostics announced that the Vitros HIV Combo test received approval from the US FDA for use on the company’s Vitros 5600 Integrated System.
Vitros HIV Combo, a fourth-generation test, detects both HIV-1 and HIV-2 antibodies and the p24 antigen, enabling detection of acute HIV-1 infection earlier than third-generation tests, the company said.
The clinical and technical performance of the Vitros HIV Combo test was evaluated at three external testing laboratories in the US and at Ortho’s research and development laboratories. This assessment confirmed that the test provides competitive sensitivity and specificity when compared to a leading commercially available fourth-generation test.
In the comparison studies, assay sensitivity was evaluated on seroconversion panels. The Vitros test showed earlier detection of acute HIV infection in six of 32 seroconversion panels when compared to a leading commercially available fourth-generation Ag/Ab test, indicating that the assay performance is very competitive in shortening the diagnostic window – a valuable attribute in HIV testing.
The test’s p24 sensitivity with specificity is enhanced by a combination of technologies available on Vitros Systems, according to Ortho.