BORDETELLA PERTUSSIS BY PCR

Mnemonic

BPERPCR

Synonym

Whooping Cough by PCR - Bordetella Pertussis/Parapertussis by PCR

Specimen Collection Requirements

Collect

Preferred Specimen:  Nasopharyngeal swabs in Stuarts, Remel M4, Remel M4RT.  Other acceptable transport media:  Copan Universal Transport Media (UTM-RT, BD Universal Viral Transport, V-C-M Medium for Quest Diagnostics and HealthLink Inc. Universal Transport Medium).

Also acceptable: Nasopharyngeal aspirate or nasal wash. See Viral Pertussis Collection.

View Swab Collection Guide

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; Refrigeration: 8 days; Frozen: 8 days

Testing Information

Note

Critical sterile. 

Performed

Monday – Friday

Reported

1-3 days

Method

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.

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

This test uses the insertion sequences IS481 to detect B. pertussis and IS1001 to detect B. parapertussis.  However, many Bordetella species carry these insertion sequences (IS) and can cause false positives.  IS481 is also found within the genome of Bordetella homesii and Bordetella bronchiseptica and IS1001 can be present in the genome of Bordetella bronchiseptica.  If clinical presentation does not indicate B. pertussis as the cause, further investigation should be followed in accordance with published guidelines.

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

CPT Codes

87798

Last Updated: Thursday, January 5, 2017 03:42:00 AM