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FDA OKs Vitros HIV Combo on Vitros 5600

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Nov. 15, 2018Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator received FDA approval for use on Ortho’s Vitros 5600 Integrated System. The Vitros HIV Combo, a fourth-generation test, detects both HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag).

“Ortho is committed to expanding its assay menu to meet current guidelines and testing needs,” Jennifer Paine, Ortho’s EVP and chief product portfolio and QRC officer, said in a statement. “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.”

The clinical and technical performance of the Vitros HIV Combo test on Vitros Systems was evaluated at three external testing laboratories in the U.S. and at Ortho’s research and development laboratories. In the comparison studies, assay sensitivity was evaluated on seroconversion panels. The company reported that the Vitros HIV Combo test showed earlier detection of acute HIV infection in six of 32 seroconversion panels (agreement for 25 of 32 panels) when compared with a leading commercially available fourth-generation Ag/Ab test, indicating that the assay performance is competitive in shortening the diagnostic window.

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