FDA approves new HIV, hepatitis screen

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FDA approves new HIV, hepatitis screen

Published: Dec. 30, 2008 at 10:54

PLEASANTON, Calif., Dec. 30 (UPI) -- The U.S. government Tuesday approved a

nucleic acid test that screens for less common forms of HIV that recently have

appeared in the United States.

The U.S. Food & Drug Administration approved the test from the Swiss firm Roche

Diagnostics to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and

hepatitis B DNA.

The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system,

is a qualitative test for human plasma. The test, which is not intended for use

as an aid in diagnosis, is designed to further increase the safety of blood

supplies by identifying infections earlier than traditional serology tests --

identification of antibodies in the blood, statement from the drug company said.

" Roche is committed to meeting the needs of blood centers with tests and systems

that ensure the highest blood safety, " O'Day, head of Roche Molecular

Diagnostics, the business area of Roche Diagnostics that developed the test,

said in a statement.

" Our multiplex test has been widely adopted and has demonstrated excellent

performance in blood centers worldwide. "