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First fully automated blood screening test for HTLV-I/HTLV-II receives US FDA approval

Abbott Laboratories Medical Diagnostics Products : 22 January, 2008  (New Product)
Abbott has received approval from the US 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-HLTV-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 US 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.

'With the Abbott Prism system, we continue to support the infectious disease testing needs of the laboratory while helping them realize greater efficiencies and enhanced operator safety throughout the blood and plasma screening process,' said Robert Doss, PhD, divisional vice president, diagnostics research and development, Abbott. 'The introduction of the Prism HTLV-I/HTLV-II test reinforces Abbott's role as a leader in ensuring the safety of the world's blood supply.'

In 1985, Abbott developed the first HIV blood-screening test approved in the USA. Today, Abbott's infectious disease tests are used thousands of times every day around the globe for blood screening and diagnostic testing. According to the American Association of Blood Banks (AABB), eight million volunteers donate about 15 million units of whole blood each year. Each donated unit of blood is tested for infectious diseases including hepatitis, HIV and other retroviruses.

The Abbott Prism HTLV-I/HTLV-II test (human T-lymphotropic virus Types I and II) can be used by laboratory technicians 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-HLTV-I/HTLV-II). The Assay has not been validated for use with pooled specimens. The Assay is not intended for use on cord blood specimens or for the laboratory diagnosis of HTLV-I/HTLV-II infection.
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