The FDA has recategorized the illumigene® Group A Streptococcus and illumigene Group B Streptococcus tests from Meridian Bioscience Inc, Cincinnati, as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments (CLIA).
Moderately complex tests are assays that are considered to be simple and easy to use.
“The Moderate Complexity classification of the illumigene Group A Streptococcus test and the illumigene Group B Streptococcus test, along with illumigene C. difficile, enables more labs to adopt molecular testing thereby helping to provide better patient outcomes,” says Jack Kraeutler, CEO, Meridian.
This categorization makes the benefits of this testing platform available to all Moderate Complexity labs in US hospitals and clinics, so they can now offer the company’s rapid, simple molecular test for each of these pathogens.
illumigene Group A Streptococcus is a qualitative molecular test 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, with an estimated 15 million visits per year in the United States. Clinical studies show that illumigene Group A Streptococcus increased detection of positives by 53% over traditional culture in symptomatic patients.
Group B Streptococcus (GBS) continues to be a major perinatal pathogen, for mothers and their infants, and is associated with significant morbidity and mortality. illumigene Group B Streptococcus fully complies with the guidelines from the Centers for Disease Control and Prevention for the detection of GBS, and clinical studies have shown that broth enrichment, followed by testing with illumigene Group B Streptococcus, increased detection of true positives by 29% over traditional culture, thus allowing for appropriate treatment of mother at time of delivery, ensuring the best outcome for baby.