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FDA Approves First-of-Its-Kind HIV Test Which Can Detect HIV Days Earlier Than Current U.S. Tests
Date:6/21/2010

of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody.

The ARCHITECT HIV Ag/Ab Combo is not intended for use in screening blood or plasma donors. The effectiveness of ARCHITECT HIV Ag/Ab Combo for use in screening blood or plasma donors has not been established. However, this assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical. The performance of this assay has not been established for individuals younger than two years of age. Definitive diagnosis of HIV infection in early infancy requires other assays. Assay results should be interpreted in conjunction with the patient's clinical presentation, history, and other laboratory results. If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result. This product requires the handling of human specimens. It is recommended that these reagents and human specimens be handled in accordance with the OSHA Standard on Bloodborne Pathogens. Assay specific information is presented in the assay package insert which can be accessed at www.abbottdiagnostics.com once the product is available.

About HIV

The CDC estimates that there are 56,000 new cases of HIV in the United States annually, and that every nine and a half minutes, someone in the country is infected with HIV. UNAIDS estimates that 2.7 million people throughout the world are newly infected with HIV each year. Leading risk factors for HIV infection include high-risk heterosexual contact, intravenous drug use, and male-to-male sexual contact.


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