Food and Drug Administration - March 28, 2008

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.

FDA-approved assays for diagnosis and donor screening for HIV are listed at http://www.fda.gov/cber/products/testkits.htm.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

080327
FD080307

SOURCE: Food and Drug Administration (FDA).

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