Simplexa® Bordetella Direct Kit

Direct detection and differentiation of Bordetella pertussis and Bordetella parapertussis.

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. There were 48,227 cases reported in the United States in 2012, making it the year with the highest number of reported cases since 1955.1 The World Health Organization estimates that there are 50 million whooping cough cases worldwide each year, resulting in 350,000 deaths.2,3 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.4

1. Centers for Disease Control Data. Available at: https://www.cdc.gov/pertussis/outbreaks/trends.html
2. Kerr et al. Eur J Clin Microbiol Infect Dis. 2000. 19:77-88. 
3. Loeffelholz, M.J. J. Clin Microbiol. 2012. 50:2186-2190. 
4. Leber, A.L. Clin Lab Med. 2014. 34:237-255.

Why to choose it

A CLIA moderate complexity assay for the direct detection and differentiation of the B. pertussis IS481 and B. parapertussis IS1001 repeat elements. The assay improves efficiency with a true sample-to-answer workflow without DNA extraction.

Benefits

Simple

Simple and Dependable Bordetella Testing

RESULTS IN 1 h

The Simplexa® Bordetella Direct assay provides results in about an hour from nasopharyngeal specimens without the need for DNA isolation.

Reliability

Reliable performance that you can count on

In a thorough study of over 1300 samples, our Simplexa® Bordetella Direct assay showed a positive percent agreement greater than 91% and a negative percent agreement greater than 97% for both Bordetella pertussis and Bordetella parapertussis.

Simplexa® Bordetella Direct Clinical Agreement Study
Specimen Positive % Agreement Negative % Agreement
SpecimenBordetella pertussis

prospective fresh samples

Positive % Agreement100.0% (36/36)
95% CI: 90.4% to 100.0%
Negative % Agreement97.9% (326/333)
95% CI: 95.7% to 99.0%
SpecimenBordetella pertussis

prospective frozen samples

Positive % Agreement91.9% (68/74)
95% CI: 83.4% to 96.2%
Negative % Agreement98.7% (1026/1039)
95% CI: 97.9% to 99.3%
SpecimenBordetella parapertussis

prospective fresh samples

Positive % Agreement100.0% (2/2)
95% CI: 34.2% to 100.0%
Negative % Agreement100.0% (174/174)
95% CI: 97.8% to 100.0%
SpecimenBordetella parapertussis

prospective frozen samples

Positive % Agreement100.0% (13/13)
95% CI: 77.2% to 100.0%
Negative % Agreement99.6% (1096/1100)
95% CI: 99.1% to 99.9%
SpecimenBordetella parapertussis

contrived frozen samples

Positive % Agreement100.0% (56/56)
95% CI: 93.6% to 100.0%
Negative % Agreement100.0% (56/56)
95% CI: 93.6% to 100.0%


Ordering info

Product Code Reactions
Product

Simplexa® Bordetella Direct

Code MOL2750 Reactions 24
Product

Simplexa® Bordetella Positive Control Pack

Code MOL2760 Reactions 10

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