Nov. 30, 2018–Ortho Clinical Diagnostics announced that its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator received FDA approval for use on the company’s Vitros ECi/ECiQ Immunodiagnostic Systems. Vitros HIV Combo, a fourth-generation test, detects HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag).
“Early detection of HIV-1 is critical in getting patients into treatment as soon as possible after infection,” Jennifer Paine, Ortho’s chief product portfolio and quality, regulatory, and compliance officer, said in a press release. “Ortho is proud to be working to deliver our Vitros HIV Combo test to customers worldwide.”
The Vitros HIV Combo test was previously approved for use on Ortho’s Vitros 5600 Integrated System and Vitros 3600 Immunodiagnostic System.