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Meridian illumigene® Streptococcus Tests Now 'Moderate Complexity'

The FDA has re-categorized Meridian´s illumigene® Group A Streptococcus and illumigene® Group B Streptococcus tests 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.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. Group B Streptococcus fully complies with the CDC 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.

Jack Kraeutler, Chief Executive Officer, 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 C. difficile, enables more labs to adopt molecular testing thereby helping to provide better patient outcomes.”

 


     
Tags: Clostridium difficile, Streptococcus, Pathogen, FDA, Group A Streptococcus

Date Published: March 26, 2013

Source article link: Meridian » company contact details
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