Streptococcus Tests Categorized as Moderately Complex

Streptococcus groups A and B tests have been recategorized as being moderately complex. Moderately complex tests are assays that are considered to be simple and easy to use.

Meridian Bioscience (Cincinnati, OH, USA) announced that illumigene Group A Streptococcus and illumigene Group B Streptococcus tests were categorized “Moderate Complexity” by the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

The Moderate Complexity categorization of both of these tests allows the benefits of the illumigene platform to be available to all Moderate Complexity laboratories that are in US hospitals and clinics, enabling them to offer an accurate, rapid, simple molecular test for each of these pathogens.

The 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 both mothers and their infants, and is associated with significant morbidity and mortality. illumigene Group B Streptococcus fully complies with the US Centers for Disease Control and Prevention (CDC; Atlanta, GE, USA) guidelines 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.

Group A Streptococcus continues to be the number one cause of acute bacterial pharyngitis while Group B Streptococcus, or GBS, is a gram positive bacteria commonly found in the gastrointestinal, genital, and urinary tract of healthy adults. Approximately 10%–30% of all pregnant women are colonized with GBS. While Group B Streptococcus-colonized mothers typically show no symptoms or adverse health effects, the bacteria can be passed to their child during labor and delivery.

Jack Kraeutler, CEO of Illumigene stated, “Due to its simplicity and superior accuracy, our illumigene technology platform enables most clinical labs to perform sophisticated molecular diagnostics without the high costs of capital equipment and ongoing service charges. The Moderate Complexity classification of the illumigene Group A Streptococcus test and the illumigene Group B Streptococcus test, along with illumigene Clostridium difficile, enables more labs to adopt molecular testing thereby helping to provide better patient outcomes.”

Related Links:
Meridian Bioscience
US Food and Drug Administration
US Centers for Disease Control and Prevention