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NEW YORK (360Dx) –Ortho Clinical Diagnostics said today that the US Food and Drug Administration has cleared its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on the Vitros 3600 Immunodiagnostic System. 

The Vitros HIV Combo is a fourth-generation test that detects both HIV-1 and HIV-2 antibodies and the p24 antigen, and enables detection of HIV-1 acute infection earlier than by third-generation tests, Ortho said. 

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.