Assay methodology is Polymerase Chain Reaction (PCR) targeting the insertion sequences IS481 and IS1001 for the qualitative detection of Bordetella pertussis and Bordetella parapertussis.
This test, which uses Research Use Only reagents, was developed and its performance characteristics determined by Legacy Laboratory Services to be the following:
Analytical Sensitivity / Specificity:
B. pertussis - 100% / 96% (n=141)
B. parapertussis - 100% / 100% (n = 141)
Limit of Detection:
B. pertussis - 43 CFU/mL
B. parapertussis - 503 CFU/mL
A negative result does not rule out the presence of B. pertussis or B. parapertussis below the level of detection by the assay or the presence of PCR inhibitory substances.
A false positive for B. pertussis may occur in samples containing B. holmesii or B. bronchiseptica DNA. A false positive for B. parapertussis may occur in samples containing B. bronchiseptica DNA.
This test has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.