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HIV screening test Abbott Prism HIV O Plus gets US FDA approval

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Tuesday, September 22, 2009, 14:48 This news item was posted in medical devices category and has 0 Comments so far.

Abbott Prism HIV O Plus test, an automated blood screening test for HIV-1/HIV-2, has been approved by the US Food and Drug Administration (USFDA).

Abbott Prism HIV O Plus test, developed by Abbott Laboratories, can be used by laboratory professionals to screen individual donors of blood and plasma to check for antibodies to human immunodeficiency virus (HIV) type 1 Groups M and O and type 2 (anti-HIV-2), and as an aid in the diagnosis of HIV-1/HIV-2 infection.

Abbott Prism HIV O Plus test for HIV Types 1 and 2 is an E. coli, B. megaterium, recombinant antigen and synthetic peptide test.

Abbott Prism HIV O Plus test 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).

There are two types of HIV. HIV type 1 consists of various subgroups, including group M, the most common subgroup of the virus in the United States, and group O, found primarily in Cameroon and other areas of West Africa.

HIV type 2 is found mostly in West Africa. Both types have been detected in the United States and Europe.

The Abbott Prism HIV O Plus assay detects antibodies to HIV type 1, groups M and O, and HIV type 2. It is the second donor screening test licensed for the detection of antibodies to HIV type 1, group O.

The Abbott Prism HIV O Plus assay is licensed to screen donated blood and blood specimens from other living donors for these specific types of HIV and subgroups of HIV type 1. The assay is also licensed to screen specimens from organ donors when specimens are obtained while the donor’s heart is still beating and from cadavers. Positive results from the screening test require confirmation from supplemental tests.

Abbott Prism HIV O Plus test 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.

Abbott Prism HIV O Plus test 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.

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 Prism system now includes 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).

Abbott Prism, which is used to screen the majority of the blood supply in the United States, is currently used in more than 30 countries and around the world, Abbott said in a press release.

Abbott’s Diagnostics Businesses, is a division of Abbott Labs. Abbott’s Diagnostics Businesses is a global leader in in vitro diagnostics and offers a broad range of instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics.

Head-quartered in Abbott Park, Illinois, Abbott is a global health care company that manufactures and markets of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

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