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# Ortho Vitros HIV Test Approved
- URL: https://www.fdaweb.com/ortho-vitros-hiv-test-approved/
- Published: 2018-11-06T12:00:00.000Z
- Updated: 2026-09-15T00:42:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142753

FDA has approved Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Ortho’s Vitros 5600 Integrated System. The combination test is designed to detect both HIV-1 and HIV-2 antibodies and the p24 antigen, enabling detection of acute HIV-1 infection earlier than third-generation tests, the company says.

  
The company says test’s clinical and technical performance was evaluated at three external testing laboratories in the U.S. and at Ortho’s research and development laboratories. The assessments “confirmed that the test provides competitive sensitivity and specificity when compared to a leading commercially available fourth-generation test,” it says. “In the comparison studies, assay sensitivity was evaluated on seroconversion panels.” The test showed earlier detection of acute HIV infection in six of 32 seroconversion panels (agreement for 25 of 32 panels) when compared to the leading test.