Chembio Diagnostics, Medford, NY, has received a CLIA waiver from FDA for its DPP HIV 1/2 assay after previously receiving FDA clearance for the diagnostic. The latest authorization will enable the company to expand into new channels such as physician office labs, clinics, and other community healthcare facilities.
The DPP HIV 1/2 assay is one of two FDA-approved, CLIA-waived oral-fluid HIV 1/2 rapid tests currently available in the United States. The assay detects HIV antibodies in oral fluid or blood using Chembio’s patented dual path platform (DPP). A SampleTainer specimen collection bottle also provides a secure, closed system for collecting potentially infectious samples.
John Sperzel, Chembio
“Accurate diagnostic testing is an important tool in the battle against HIV/AIDS,” says John Sperzel, CEO of Chembio. “Our DPP HIV 1/2 assay combines excellent sensitivity and specificity, simple and safe oral fluid sample collection, and exceptional ease of use. We believe this combination will lead to more testing, which will result in increased detection, earlier treatment, and lower exposure rates. We recently signed agreements with several major US distributors for the DPP HIV 1/2 and HIV 1/2 STAT-PAK assays and, with receipt of this latest waiver, we will expand our US sales and marketing effort as planned.”
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) were passed by Congress to set standards for all laboratory testing, and amended in 2008 to establish more stringent guidelines for in vitro diagnostics. CLIA standards require that only accurate, easy-to-use tests be performed in the physician’s office. FDA makes CLIA complexity determinations based on evaluations conducted in a CLIA-waived environment by intended users such as physicians, nurses, and medical assistants.
For more information, visit Chembio.
