US approval for Abbott's fully automated blood screening tests for
26 July 2006
Illinois, USA. Abbott (NYSE:ABT) has announced it has received approval
from the U.S. Food and Drug Administration for its Prism hepatitis B surface
antigen (HBsAg) and its Prism HBsAg confirmatory test. These tests can be
used by laboratory technicians to screen donated blood for HBsAg.
Used in more than 30 countries, the Prism system was recently approved
for use in the United States with its first hepatitis B test, Prism HBcore,
introduced in October. Additional hepatitis and retrovirus screening tests
are currently under FDA review.
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
"We continue to focus on expanding our automated hepatitis testing menus
across all of our diagnostic platforms," said Don Patton, vice president,
global diagnostic commercial operations, Abbott. "We also will continue to
leverage our scientific expertise and understanding of viral hepatitis in
introducing new diagnostic tests to support laboratory needs in infectious
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.