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Rapid HIV tests
nearing FDA approval
FDA moves closer to approving rapid HIV tests that provide results in 15 minutes.
Chembio Diagnostics, a Medford, N.Y.-based company specializing in diagnostic tests for infectious diseases, has moved closer to Food and Drug Administration approval of its rapid HIV antibody tests, Newsday reports. The FDA issued an approvable letter, pending a final review of package inserts for the tests, called the Sure Check HIV 1-2 and the HIV 1-2 Stat-Pak. The tests, designed for use by hospitals and clinical laboratories, can detect antibodies to HIV-1 and HIV-2 in about 15 minutes. (The Advocate)
