Following withdrawal from the market of the bioMérieux Vironostika assay in 2007, laboratories were left without an FDA-approved option for testing oral fluid specimens. In response, APHL sought and received approval from the Centers for Medicare & Medicaid Services to allow public health laboratories to perform a small scale validation of a serum-based HIV screening assay to test oral fluid specimens. Most laboratories that continued to test oral fluid specimens utilized the BioRad HIV-1/HIV-2 Plus O immunoassay. The proposal helped public health laboratories continue oral fluid testing with minimal interruption. In September of 2009, Avioq Inc received FDA approval for their HIV-1 Microelisa system. This first generation viral lysate immunoassay is approved for testing serum, plasma, oral fluid, and dried blood spot specimens. A limited amount of comparative performance data is available upon request.
Many public health laboratories have asked whether they should switch to this new, FDA-approved assay. According to CMS, laboratories are not required to switch if they previously conducted a full validation that included setting performance specifications and steps to take if the test is not meeting those specifications. Laboratories that took advantage of the CMS-approved limited validations will need to implement the FDA-approved assay or perform a full validation on a different assay. If you have questions about what constitutes a full validation, you should contact your CLIA surveyor. Other questions about oral fluid testing may be directed to Tam Van, Manager, HIV, Hepatitis, STD and TB Programs.