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# Ortho Gains Expanded Use for HIV Combo Test
- URL: https://www.fdaweb.com/ortho-gains-expanded-use-for-hiv-combo-test/
- Published: 2018-11-28T12:00:00.000Z
- Updated: 2026-09-15T00:47:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142909

FDA has approved an Ortho Clinical Diagnostics expanded indication for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Ortho’s Vitros ECi/ECiQ Immunodiagnostic Systems. The HIV combo test was previously approved for use on Ortho’s Vitros 5600 Integrated System and Ortho’s Vitros 3600 Immunodiagnostic System. The test is used to detect both HIV-1 and HIV-2 antibodies and the p24 antigen. The company says that detecting the antigen itself, rather than only the antibodies to the antigen, allows earlier detection than previous tests.