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FDA Approves New Gene-Based Diagnostic Test for HIV-1

RNA test may detect virus before antibodies are made

FRIDAY, Oct. 6 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first test aimed at detecting HIV-1 RNA in the blood to help diagnose and confirm infection. The APTIMA HIV-1 RNA Qualitative Assay, which is made by Gen-Probe Inc., of San Diego, Calif., may detect virus in early infection before HIV-1 antibodies surface.

The gene-based HIV-1 test could serve as a stand-in for the sometimes inconclusive Western blot test that now confirms HIV-1 infection after positive HIV-1 antibody tests, according to an FDA statement.

"This product offers medical diagnostic laboratories the ability to perform a gene-based test for HIV-1 that, until now, was only available as part of a larger kit used to screen blood and plasma donors," Jay Epstein, M.D., of the FDA, said in a statement. "This test also can detect infection with HIV-1 earlier than HIV antibody tests."

The new test is as sensitive as those now used to calculate the viral load in previously diagnosed patients, the FDA said. However, the new test is approved both to confirm HIV-1 infection in the case of positive antibody tests and to diagnose primary infection with HIV-1.

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