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Ortho Clinical Diagnostics HIV Combo Test Gets Expanded-Use Approval From FDA

NEW YORK (360Dx) – Ortho Clinical Diagnostics said today that the US Food and Drug Administration has approved the expanded use of its Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator on its Vitros ECi/ECiQ Immunodiagnostic Systems.

The FDA had previously approved marketing of the diagnostic test, also called the Vitros HIV Combo, for use on Ortho's Vitros 5600 Integrated System and Vitros 3600 Immunodiagnostic System.

HIV Combo, a fourth-generation test, detects HIV-1 and HIV-2 antibodies and the p24 antigen. By detecting the antigen as well as antibodies to the antigen, the test detects HIV-1 acute infection earlier than previous generations of tests, Ortho said.

"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 statement.