DiaSorin Molecular LLC, Cypress, Calif, has received FDA clearance for its new Simplexa Bordetella Direct test.
Categorized as a moderate-complexity assay under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the assay is designed for use on the company’s Liaison MDx analyzer to quickly provide qualitative detection and differentiation of both Bordetella pertussis and Bordetella parapertussis in nasopharyngeal swabs. The assay is performed directly from nasopharyngeal swab samples without extraction, and provides results in about an hour.
Pertussis, or whooping cough, is a highly contagious disease of the respiratory system caused by small, gram-negative B. pertussis and B. parapertussis bacteria. While most cases are caused by B. pertussis, some milder cases have been linked to B. parapertussis. Pertussis can lead to more severe symptoms such as hypoxia, permanent brain damage, or death, particularly in infants.
In spite of high vaccination rates in developed countries, since the late 1990s there has been a marked increase in the number of reported pertussis cases. There were 48,227 cases reported in the United States in 2012, the highest number of reported cases since 1955. The World Health Organization estimates that there are 50 million whooping cough cases worldwide each year, resulting in 350,000 deaths.
“Whooping cough can be detected among all age groups and has seen a resurgence in recent years,” says Michelle Tabb, chief scientific officer at DiaSorin Molecular. “We are very excited about our addition of the Simplexa Bordetella Direct assay, as it will help in the detection and appropriate treatment of this infectious disease. The assay meets the needs of today’s laboratories by detecting both B. pertussis and B. parapertussis with a simple workflow.”
For further information, visit DiaSorin Molecular.