Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
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United Press International - October 5, 2006
The new diagnostic -- which experts say might ultimately replace the standard "Western blot" test used to confirm an HIV-positive test result -- is sold by San Diego-based Gen-Probe under the trade name Aptima.
The new genetic test also allows detection of the HIV virus at an earlier point than was previously possible -- before HIV antibodies even appear in the patient's system.
"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," said Jay Epstein, director of the FDA's Office of Blood Research and Review at the agency's Center for Biologics Evaluation and Research. "This test also can detect infection with HIV-1 earlier than HIV antibody tests when used to detect primary HIV-1 infection."
Health experts say the Western blot test sometimes yields inconclusive results and can be hard to interpret.
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