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Ortho Clinical Diagnostics Gets FDA Clearance for HIV Combo Test on Immunodiagnostic System

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. 

The clinical and technical performance of the Vitros HIV Combo test running on Vitros systems was evaluated during routine use at three external testing laboratories in the US and at Ortho's research and development laboratories, the firm said, adding that the assessment confirmed that the test provides competitive sensitivity and specificity when compared to an unspecified commercially available fourth-generation test.

Clinicians evaluated the assay's sensitivity on seroconversion panels to conduct comparison studies. The HIV combination test showed earlier detection of acute HIV infection in six of 32 seroconversion panels, and agreement for 25 of the 32 panels, when compared to the commercially available fourth-generation Ag/Ab test, Ortho said.

Ortho said that the test's sensitivity and specificity is improved by a combination of its MicroWell technology and "enhanced chemiluminescence detection."

The firm said that it plans to file premarket approval supplements for use of the Vitros HIV Combo test on its Vitros ECi/ECiQ Immunodiagnostic Systems and its Vitros 5600 Integrated System.