FDA approves Avioq's HIV detection system
This article was originally published in Clinica
Avioq's HIV-1 microelisa system has received a premarket approval (PMA) from the US FDA. The test detects antibodies to HIV-1 in human serum, plasma, dried blood spots or oral fluid obtained using OraSure Technologies' HIV-1 oral specimen collection device, and is designed to aid HIV diagnosis. It is the only assay approved by the FDA for use with oral fluid specimens, the Research Triangle Park, North Carolina company claims. The test has shown "excellent sensitivity and specificity in clinical studies", Avioq added.