In-vitro diagnostics maker Ortho Clinical Diagnostics has received approval from the US Food and Drug Administration (FDA) for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (Vitros HIV Combo test).
Indicated for use on the firm’s Vitros 3600 Immunodiagnostic System, the fourth-generation test is designed to identify HIV-1 and HIV-2 antibodies (Ab).
The test could also detect the p24 antigen (Ag), leading to early identification of acute HIV-1 infection, compared with third-generation tests.
