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NEW YORK (360Dx) – The US Food and Drug Administration has approved Ortho Clinical Diagnostics' Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on the Vitros 5600 Integrated System, the company announced today.

The Vitros HIV Combo is a fourth-generation tests that detects HIV-1 and HV-2 antibodies, and the p24 antigen. As a result it can detect acute HIV-1 infection earlier than third-generation tests, Ortho Clinical 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.