FDA Approves New Hepatitis C Test

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.c The Associated Press

WASHINGTON (AP) -- The government approved a more accurate test for hepatitis C Friday, a move that could help blood banks more accurately track people who may have caught the dangerous liver virus from pre-1992 blood transfusions.

An estimated 3.9 million Americans have hepatitis C, thousands of whom caught it from transfusions before purity tests of the blood supply began in 1992.

The hepatitis C virus sometimes destroys people's livers, yet many carriers don't know they have it.

So under new government rules, blood banks are testing leftover samples of pre-1992 transfusions. When a test indicates a batch of blood could have contained hepatitis C, hospitals will track people who received that blood and urge them to be checked for infection.

The test that blood banks have had to use until now sometimes classified blood samples as ``indeterminate'' -- it couldn't always rule out infection in samples that were fine. That meant thousands of people who aren't sick could be scared into getting an unnecessary hepatitis test.

The new test, Chiron Corp.'s RIBA HCV 3.0, is more accurate, the Food and Drug Administration said Friday. In one study in which a competing test declared 30 percent of samples indeterminate, the RIBA 3.0 found only 7 percent inconclusive.

AP-NY-02-12-99 1536EST
Copyright 1998 The Associated Press.


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