Luminex Corp, Austin, Tex, has received FDA clearance for the Aries Bordetella assay for direct detection and identification of Bordetella pertussis and Bordetella parapertussis nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. This is the fourth assay the FDA has cleared since October 2015 for use on Luminex’s Aries systems.
Pertussis, commonly known as whooping cough, is a contagious respiratory disease caused by the organism Bordetella pertussis. This infection can lead to life-threatening complications in infants and young children. Worldwide, there are an estimated 16 million cases of pertussis and about 195,000 deaths per year.
The Aries assay is a real-time polymerase chain reaction-based qualitative in vitro diagnostic test that targets the pertussis toxin (ptxA) promoter and IS1001 repeat sequence in the genomes of B. pertussis and B. parapertussis, respectively.
“Healthcare systems like ours will benefit from having a molecular assay for B. pertussis and B. parapertussis available in a moderate complexity sample-to-answer format,” says John W. Longshore, PhD, director of molecular pathology at the Carolinas HealthCare system. “The newly cleared bordetella assay from Luminex should aid in efficient patient diagnosis and B. pertussis reporting to the CDC.”
Aries systems automate all aspects of testing, from sample preparation through analysis, providing answers in less than 2 hours with minimal hands-on time.
“The high specificity of our bordetella assay combined with the rapid results provided by the Aries platform should lead to more positive patient outcomes,” says Homi Shamir, president and CEO of Luminex. “The Aries Bordetella assay is a cost-effective option for lower volume labs desiring high-performance molecular testing, and is part of a growing menu of tests from Luminex that can be adapted to fit the respiratory testing needs of any clinic.”
For more information, visit Luminex.