Jul 20 2006
The U.S. Food and Drug Administration has given the go-ahead for a device, called Cell-Dyn Ruby, which uses laser optics and provides diagrams showing changes in white and red blood cells and platelets.
The fully automated blood screening tests will be used by laboratory technicians to screen donated blood for Hepatitis B.
PRISM HBcore is already used in more than 30 countries, and additional hepatitis and retrovirus screening tests are also currently under FDA review.
According to the American Association of Blood Banks (AABB), 8 million volunteers donate about 15 million units of whole blood each year.
Each donated unit of blood must be tested for infectious diseases including hepatitis, HIV and other retroviruses.
Abbott developed the first HIV blood-screening test approved in the United States in 1985, and the company's hepatitis tests are used thousands of times every day around the globe for blood screening and diagnostic testing.
The advantage of the PRISM instrument is that it 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.