Meridian Bioscience Inc, Cincinnati, announced that it has received FDA clearance for a new molecular diagnostic test for Group A Streptococcus on the illumigene® platform.
Approximately 20-30% of children seeking physician care are diagnosed with Group A Strep pharyngitis. Traditional laboratory diagnosis is performed by rapid antigen testing or throat swab culture. Studies show that culture may miss up to 10% of true positives. The illumigene Group A Strep test utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes in throat samples. The test procedure is remarkably simple and highly sensitive. It requires no expensive capital equipment. The test relies upon a simple procedure that takes less than one hour. All reagents and disposables are contained in the test kit and can be stored at room temperature.