HealthDay News — The FDA has approved the first rapid diagnostic test to detect the HIV-1 antigen, as well as blood antibodies for the HIV-1 and HIV-2 strains, to aid healthcare providers in identifying people with HIV who might not be able to be tested in traditional health setting.
The Alere Determine HIV-1/2 Ag/Ab Combo test can detect these markers for the virus in human serum, plasma and blood specimens, the agency said in a press release. Detection of the HIV-1 antigen may allow doctors to diagnose the viral infection earlier than detection of the antibodies alone.
“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research said. “Earlier diagnosis may also help to reduce additional HIV transmission.”
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Some 50,000 people are infected with HIV each year in the United States, according to the CDC. Among the more than one million people living with HIV in the United States, about 20% haven’t been diagnosed.
The new test is produced by Orgenics Ltd., whose parent, Alere Inc., is based in Yavne, Israel.
