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U.S. Department of Health and Human Services

For Consumers

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Approval of VITROS Anti-HIV 1+2 diagnostic immunoassay

On March 27, 2008, FDA approved a new HIV diagnostic test, the VITROS Anti-HIV 1+2 Reagent Pack and VITROS Anti-HIV 1+2 Calibrator, manufactured by Ortho-Clinical Diagnostics. The VITROS Anti-HIV 1+2 Reagent Pack and VITROS Anti-HIV 1+2 Calibrator is an in vitro chemiluminescent immunoassay intended for the in vitro qualitative detection of antibodies to human immunodeficiency virus types 1 and 2 in human serum and plasma using the VITROS ECi/ECiQ Immunodiagnostic System.

The results of the VITROS Anti-HIV 1+2 assay, in conjunction with other serological evidence and clinical information may be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in persons with signs or symptoms of, or at risk for, HIV infection.

The assay is highly sensitive and specific for the detection of anti-HIV types 1 and 2 antibody. The VITROS ECi/ECiQ Immunodiagnostic System is fully automated, reducing the potential for operator errors, with redundant checks to ensure integrity of the system. This automation allows for increased efficiency and convenience.

You can find a Complete list of FDA-approved assays for diagnosis and donor screening for HIV on the FDA web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration