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Approval of First Fully Automated Blood Screening Test for HTLV-I/HTLV-II

Abbott announced that it has received approval from the U.S. Food and Drug Administration for its fully automated HTLV-I/HTLV-II blood screening test for use on the ABBOTT PRISM instrument. The test is intended for use by laboratories to screen individual donations of blood and plasma for antibodies to human T -- lymphotropic virus Type I and/or human T -- lymphotropic virus Type II (anti-HTLV-I/HTLV-II).

HTLV-I and HTLV-II are closely related but distinct retroviruses associated with several diseases including human T-cell leukemia and neurological disorders, according to the Centers for Disease Control. Screening of the U.S. blood supply for HTLV-I/II began in 1988.

Used in more than 30 countries, the PRISM system also includes four hepatitis tests: a core hepatitis B test (PRISM HBcore), introduced in October 2005; two hepatitis B surface antigen tests (PRISM HBsAg and HBsAg Confirmatory), introduced in July 2006; and a hepatitis C test (PRISM HCV), introduced in July 2007.

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Source : Abbott Laboratories View Company Information

Posted on January 23, 2008