Simplexa™ Bordetella Direct Kit

Direct detection and differentiation of Bordetella pertussis and Bordetella parapertussis.

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KIT for Infectious Diseases

Overview

Background

Pertussis, commonly called whooping cough, is a highly contagious disease of the respiratory system caused by small gram negative bacteria; Bordetella pertussis and Bordetella parapertussis. Clinically, it presents with a prolonged cough and patients with classic disease often have episodes of violent cough that may be followed by an inspiratory whoop and vomiting. The World Health Organization estimates that there are 50 million whooping cough cases worldwide each year, resulting in 350,000 deaths.^1,2 Pertussis can be detected among all age groups (e.g., neonates, children, adolescents and adults). A great majority of these cases are caused by Bordetella pertussis; however, up to 20% of cases are caused by Bordetella parapertussis, which can present clinically as a milder pertussis-like disease.³

1. Kerr et al. Eur J Clin Microbiol Infect Dis. 2000. 19:77-88.
2. Loeffelholz, M.J. J. Clin Microbiol. 2012. 50:2186-2190.
3. Leber, A.L. Clin Lab Med. 2014. 34:237-255.

Why to choose it

A CLIA moderate complexity assay with broad coverage, including both B. pertussis and B. parapertussis, for your testing needs. The assay improves efficiency with a true sample-to-answer workflow without DNA extraction.

For use on

LIAISON^® MDX

Direct Amplification Disc

Benefits

Simple

Simple and Dependable Bordetella Testing

RESULTS IN 1 h

The Simplexa^™ Bordetella Direct assay provides results in about an hour direct from nasopharyngeal swabs without the need for DNA isolation.

Reliability

Reliable performance that you can count on

In a thorough study of over 1400 samples, our Simplexa^™ Bordetella Direct assay showed a positive percent agreement of 98.9% and a negative percent agreement of 98.8% for Bordetella pertussis when compared to bi-directional sequencing with discrepant resolution on an FDA cleared nucleic acid amplification test (NAAT).

Simplexa^TM Bordetella Direct Clinical Agreement Study

Specimen	Positive % Agreement	Negative % Agreement
SpecimenBordetella pertussis prospective samples	Positive % Agreement89.1% (90/101)* 95% CI: 81.5% to 93.8%	Negative % Agreement98.8% (1179/1188)* 95% CI: 97.9% to 99.3%
SpecimenBordetella parapertussis prospective samples	Positive % Agreement100% (15/15) 95% CI: 78.2% to 100.0%	Negative % Agreement99.7% (1270/1274) 95% CI: 99.2% to 99.9%
SpecimenBordetella parapertussis contrived samples	Positive % Agreement100% (56/56) 95% CI: 93.6% to 100.0%	Negative % Agreement99.7% (56/56) 95% CI: 93.6% to 100.0%
After FDA cleared NAAT testing, the resolved Positive Percent Agreement resulted to 98.9%* (91/92) with 95% CI of 94.1% to 100.0% and resolved Negative Percent Agreement to 98.8% (1183/1197) with 95% CI of 98.1% to 99.4%.