Rapid HIV Tests Performed on Minute Blood Samples

Tests are complete within approximately 15 minutes of sample application.

Chembio Diagnostics, Inc. (Medford, NY, USA) has received an "approvable” letter from the U.S. Food and Drug Administration (FDA, Rockville, MD, USA) for its Sure Check HIV 1/2 and HIV 1/2 Stat-Pak rapid test Pre-Market Applications (PMA). Chembio's PMA approval is subject only to final review by the FDA of the products' package inserts and other standard conditions related to all PMAs. Chembio anticipates that the approval will be given very soon allowing the company to market its tests to clinical laboratories and hospitals in the United States.

Easy to perform, the two new rapid tests are highly sensitive and specific. They are safe, requiring as little as 2.5-5.0 µl, which is easily obtained from a finger prick. However, the FDA PMA approval, when granted, will be also for whole blood, serum, and plasma samples. Both products have a built-in internal control (a true IgG), and provide a 24-month shelf life at 8-30º C.

"Estimates are that as much as one-third of those infected with HIV in the US population are not aware of their HIV-Positive status. We believe that that these individuals are much more likely to access testing services if test results and counseling can be delivered at point of care,” said Lawrence Siebert, president and CEO of Chembio. Mr. Siebert continued, "The U.S. is a very important market for Chembio and those that need to be tested, as there are only two competitive products currently approved. Moreover, we believe that PMA approval, when granted, will provide further impetus to our international marketing efforts, including opening markets not currently available.”

Chembio is one of the four recommended global rapid HIV test suppliers under the U.S. Clinton HIV/AIDS initiative. The company has also developed tests for other diseases including human and veterinary tuberculosis, and Chagas disease.



Related Links:
Chembio Diagnostics
Clinton HIV/AIDS initiative