Simplexa Group A Strep Direct Kit test is 510(K) approved by the FDA-Focus Diagnostics

Focus Diagnostics has announced the FDA 510(k) clearance and CLIA moderate-complexity categorization for its Simplexa Group A Strep Direct Kit. Simplexa Group A Strep Direct is a real-time polymerase chain reaction assay for the detection of Group A Streptococcus bacteria directly from throat swabs. The test was CE marked for distribution in the European Union in February 2015.

Simplexa tests, designed for use on the 3M Integrated Cycler, employ real-time polymerase chain reaction (PCR) technology to detect DNA or RNA in viruses, bacteria, and other analytes. Using a proprietary chemistry technique that eliminates the nucleic acid extraction process typical of molecular diagnostics, Simplexa tests can produce results in as quickly as an hour. The Simplexa Group A Strep Direct test is intended for the in vitro qualitative detection of group A Streptococcus from throat swabs collected from human patients with signs and symptoms of pharyngitis, such as sore throat. Simplexa Group A Strep Direct showed strong performance in clinical studies, with 97.4% sensitivity and 95.2% specificity compared to culture.