Abbott Receives Approval For First Fully Automated Blood Screening Test
Blood Screening Test
Abbott received approval from FDA 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.
"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, Ph.D., 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 United States. 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.
Important Product Usage and Safety Information
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-HTLV-I/HTLV-II). This 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. This product contains human sourced and/or potentially infectious components.
About ABBOTT PRISM
The PRISM instrument consolidates testing into a single system automating many of the manual testing procedures and steps currently used to screen blood. Safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. The PRISM system can run 160 samples per hour, making it possible to test more than 1,200 samples per eight-hour shift.