ACON Infectious Mononucleosis Rapid Tests Receive CLIA Waiver
The U.S. FDA have granted a CLIA Waiver for the Whole Blood procedure of ACON Labs Infectious Mononucleosis Rapid Tests, available in both strip and device formats. The CLIA Waiver for the Whole Blood procedure indicates that the tests are simple enough to be used by non-laboratory trained personnel in more than 100,000 physician offices and laboratories in the USA.
The tests give results in just 5 minutes. Clinical studies demonstrated positive agreement of 97%, negative agreement of greater than 99%, and overall agreement of 99% for all specimen types combined versus a leading slide agglutination method.
Infectious Mononucleosis is caused by the Epstein-Barr virus (EBV), one of the most common human viruses. Early and rapid detection is an important first step toward treatment and avoidance of potentially serious complications
Source : ACON Laboratories, Inc. View Company Information
Posted on October 10, 2005