Skip to main content

HIV Detection Test From Ortho Clinical Approved by FDA

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.

"With the availability of the Vitros HIV Combo test on the Vitros 5600 system, laboratories can improve workflow efficiencies while helping to provide earlier detection of HIV infection," Ortho Executive Vice President and Chief Product Officer and QRC Officer Jennifer Paine said in a statement.