Abbott Receives FDA Approval For First Fully Automated Blood Screening Test For HIV-1/HIV-2

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Sep 2009 - 1:00 PDT

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Abbott announced it received approval from the U.S. Food and Drug Administration (FDA) for its ABBOTT PRISM HIV O Plus test, the first fully automated blood screening test for HIV-1/HIV-2. This test can be used by laboratory professionals to screen individual donors of blood and plasma for antibodies to human immunodeficiency virus type 1 Groups M and O (anti-HIV-1) and type 2 (anti-HIV-2), and as an aid in the diagnosis of HIV-1/HIV-2 infection.

The assay, which provides laboratories a fully automated test compared to the current method, runs on the ABBOTT PRISM system, which can run 160 samples per hour, making it possible to test more than 1,200 samples in an eight-hour shift. Speed and efficiency are important to labs given the volume of blood that is screened each year. According to the American Association of Blood Banks (AABB), eight million volunteers donate about 15 million units of whole blood each year in the United States alone. Each donated unit of blood must be tested for infectious diseases including hepatitis, HIV and other retroviruses. Abbott's hepatitis and retrovirus tests are used thousands of times every day around the globe for blood screening and diagnostic testing.

With this approval, Abbott now has a complete panel of hepatitis and retrovirus tests on the ABBOTT PRISM system which includes the following assays: a hepatitis B core test (ABBOTT PRISM HBcore); a hepatitis B surface antigen test (ABBOTT PRISM HBsAg along with ABBOTT PRISM HBsAg Confirmatory); a hepatitis C test (ABBOTT PRISM HCV); and a human T- lymphotropic virus test (ABBOTT PRISM HTLV-I/HTLV-II). Used in more than 30 countries, the ABBOTT PRISM is used to screen the majority of the blood supply in the United States and around the world.

"Abbott has a strong heritage in HIV assay development, beginning in 1985 with the first blood-screening test for HIV approved in the United States," said Mike Warmuth, senior vice president, diagnostics, Abbott. "The approval of ABBOTT PRISM HIV O Plus marks an important milestone as we continue our leadership in HIV and our work to ensure the safety of the world's blood supply."

Important Product Usage and Safety Information

The ABBOTT PRISM HIV O Plus test (Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide) can be used by laboratory professionals to screen individual donations of blood for antibodies to HIV-1 (anti-HIV-1) Groups M and O and /or antibodies to HIV-2 (anti-HIV-2). ABBOTT PRISM HIV O Plus can also be used as an aid in the diagnosis of HIV-1/HIV-2 infection. This assay has not been validated for use with pooled specimens and is not intended for use on cord blood specimens. This product contains human sourced and/or potentially infectious components. Assay specific information is presented in the assay package insert which can be accessed at www.abbottdiagnostics.com once the product is available.

About Abbott's Diagnostics Businesses

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 69,000 customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs. The history of Abbott is filled with examples of first-of-a-kind diagnostic products and significant technological and research advancements.

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Abbott

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