Method: Real-Time Polymerase Chain Reaction (PCR)
Analytical Sensitivity / Specificity: B. pertussis - 96% / 100% (n = 46) ; B. parapertussis - 100% / 100% (n = 38)
Limit of Detection: B. pertussis - 182 CFU/mL ; B. papertussis - 36,800 CFU/mL
A negative result indicates that no B. pertussis or B. parapertussis DNA was detected, but does not rule out the presence of these organisms below the limit of detection of this assay, or the presence of inhibitory substances.
Assay methodology is real-time polymerase chain reaction (RT-PCR) performed pursuant to a license agreement with Roche Molecular Systems, Inc.
This test, which uses Analyte Specific Reagents, was developed and its performance characteristics determined by Legacy Laboratory. It 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.