Meridian Bioscience, Inc., has announced it has received FDA clearance for a new molecular diagnostic test for Group A Streptococcus on the illumigene platform. Group A Streptococcus causes a wide variety of diseases in humans, the most common being acute pharyngitis or strep throat. Group A Streptococcus infections may result in mild illness (e.g. pharyngitis, impetigo) or lead to invasive, life-threatening illness such as acute rheumatic fever, cellulitis, bacteremia, necrotizing fasciitis, or Streptococcal toxic shock syndrome.
illumigene Group A Strep provides a molecular solution for the detection of Group A Strep pharyngitis. Acute pharyngitis is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted. Approximately 20% to 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. Accurate diagnosis of streptococcal pharyngitis followed by appropriate antibiotic therapy is important for the prevention and control of Group A Strep infections.
The illumigene Group A Strep test utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyrogenes in throat samples. The test procedure is highly sensitive and requires no expensive capital equipment. It 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. Learn more about diagnostic products from Meridian.
