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B PERTUSSIS DNA BY PCR

Mnemonic

PERTUS PCR

Synonym

Whooping Cough by PCR - Bordetella Pertussis/Parapertussis by PCR

Specimen Collection Requirements

Collect

Preferred Specimen: Nasopharyngeal swabs in Stuarts, M4 or M4-RT transport media. Also acceptable: Nasopharyngeal aspirate or nasal wash. See Viral Pertussis Collection.

Handling

Perform collection in appropriate media or sterile container and refrigerate or freeze.

Preferred Volume

1.0 mL

Minimum Volume

0.5 mL

Transport

Refrigerated or Frozen

Rejection Criteria

Samples collected with Amies, calcium alginate, charcoal or wooden swabs, specimens exceeding stated stability requirements, or sputum samples.

Stability

Ambient: 48 hours; Refrigerate: 7 days; Frozen: 3 months

Testing Information

Note

Critical sterile. 

Performed

Mon - Fri, batched five times per week.

Reported

1-3 days

Method

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.

Reference Values

Reference Values

Negative for Bordetella pertussis DNA. A negative result does not rule out the presence of B pertussis or parapertussis DNA below the limit of the detection method.

Comments

Bordetella holmesii cannot be ruled out.

Swabs with wooden shafts have been found to cause PCR inhibition.

CPT Codes

87798

Last Updated: Monday, November 6, 2017 03:31:04 PM


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