Abbott has received approval from the US Food and Drug Administration for its Abbott Prism HCV test. This test can be used by laboratory technicians to screen individual donations of blood and plasma for antibodies to hepatitis C (HCV).
Used in more than 30 countries, the Prism system was approved for use in the United States with its first three hepatitis B tests: a core hepatitis B test (Prism HBcore), introduced in October 2005; and two hepatitis B surface antigen tests (Prism HBsAg and HBsAg Confirmatory), introduced in July 2006. Additional retrovirus screening tests are currently under FDA review.
"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 William E Brown III, PhD, vice president, diagnostic assays and systems development, Abbott. "The introduction of the Prism HCV 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. Abbott's hepatitis 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.