Abbott's HBV blood test cleared by US FDA
US health care major Abbott Laboratories has received approval from the Food and Drug Administration for its PRISM test for the hepatitis B virus surface antigen and its PRISM HBsAg confirmatory test, which can be used by laboratory technicians to screen donated blood for the deadly liver virus
Used in more than 30 countries, the PRISM system was recently approved for use in the USA with its first hepatitis B test, PRISM HBcore, introduced in October. Additional hepatitis and retrovirus screening tests are currently under FDA review.
According to the American Association of Blood Banks, eight million volunteers donate about 15 million units of whole blood each year and every unit of blood is tested for infectious diseases including hepatitis, HIV and other retroviruses.
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