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Bordetella pertussis Plus Real-time PCR Panel

Test Code: 3100
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Clinical Utility

Real-time PCR detection of Bordetella spp. DNA in respiratory specimens may aid the diagnosis of whooping cough. Potentially fatal in infants, about half of all children diagnosed with whooping cough under the age of one will be hospitalized. In addition to supporting early diagnosis, PCR may also aid the management of outbreaks. Whooping cough may be challenging to recognize in earlier stages of the disease, as it may appear as mild respiratory disease without the characteristic "whoop."

Four species of Bordetella are known to infect humans; B. pertussis, B. parapertussis, B. holmesii and B. bronchiseptica. B. pertussis and (secondarily) B. parapertussis are the most important causes of whooping cough. Concerns about lack of protection from vaccines may make the specific detection of B. parapertussis and B. holmesii important when managing outbreaks. Disease caused by B. bronchiseptica is associated with close contact with infected animals and infections in humans are rare.

Procedure

Extraction of B. pertussis, B. parapertussis, and B. holmesii DNA from specimen followed by amplification and detection of B. pertussis, B. parapertussis, and B. holmesii DNA using qualitative real-time PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. This test was developed and its performance characteristics determined by Viracor Eurofins.  It has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

The B. pertussis, B. parapertussis, and B. holmesii PCR assays were tested for cross reactivity against close relatives of the Bordetellae and/or normal flora including all relevant species of Chlamydophila, all relevant strains of Mycoplasma pneumoniae, and all relevant species of Legionella as well as human herpes viruses, polyoma viruses, hepatitis viruses, adenoviruses, parvovirus B19, Pneumocystis jirovecii and Toxoplasma gondii with no cross reactivity noted.

Same day (within 12-18 hours from receipt of specimen), Monday through Saturday.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
BAL 3109 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected

  • Collect in a sterile, screw top tube.
  • Store and ship frozen on dry ice for overnight delivery.
bronch wash 3126 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected

  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
nasal asp 3131 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected

 

  • Collect in a sterile, screw top tube.
  • Store frozen and and ship on dry ice for overnight delivery.

 

nasal swab 3130 87798 Yes

2 mL

Detected/Not Detected

  • Place sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube.
  • Do not use calcium alginate swab or wood shafted swab.
  • Store frozen and ship on dry ice for overnight delivery.
nasal wash 3113 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected

  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
NP aspirate 3124 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected

  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
NP swab 3125 87798 Yes

2 mL

Detected/Not Detected

  • Place sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube.
  • Do not use calcium alginate swab or wood shafted swab.
  • Store frozen and ship on dry ice for overnight delivery.
NP wash 3147 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected

  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
trach asp 3119 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected

  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
trach wash 3148 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected

  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.

Qualitative results (Detected/Not Detected).

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Causes for Rejection

Wood shafted swab, calcium alginate swab, specimens received in trap containers, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor Eurofins' interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for general informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc.

References

Centers for Disease Control and Prevention (CDC). Pertussis (Whooping Cough). Accessed 10 May 2013. Available on the Centers for Disease Control and Prevention website at: http://www.cdc.gov/pertussis/clinical/disease-specifics.html.

Cherry JD, Seaton BL. Patterns of Bordetella parapertussis respiratory illness: 2008-2010. Clin Infect Dis. 2012 Feb 15;54(4):534-7.

Mattoo S, Cherry JD. Molecular pathogenesis, epidemiology, and clinical manifestations of respiratory infections due to Bordetella pertussis and other Bordetella subspecies. Clin Microbiol Rev. 2005 Apr;18(2):326-82. Review.

Lavine J, Broutin H, Harvill ET, Bjornstad ON. Imperfect vaccine-induced immunity and whooping cough transmission to infants. Vaccine. Dec 10:29(1):11-6.

Njamkepo E, Bonacorsi S, Debruyne M, et al. Significant finding of Bordetella holmesii DNA in nasopharyngeal samples from French patients with suspected pertussis. J Clin Microbiol. 2011 Dec;49(12):4347-8.

Rodgers L, Martin SW, Cohn A, et al. Epidemiologic and laboratory features of a large outbreak of pertussis-like illnesses associated with cocirculating Bordetella holmesii and Bordetella pertussis--Ohio, 2010-2011. Clin Infect Dis. 2013 Feb 56(3):322-31.

Roorda L, Buitenwerf J, Ossewaarde JM, van der Zee A. A real-time PCR assay with improved specificity for detection and discrimination of all clinically relevant Bordetella species by the presence and distribution of three Insertion Sequence elements. BMC Research Notes. 2011 Jan 21;4:11.

Zhang X, Weyrich LS, Lavine JS, Karanikas AT, Harvill ET. Lack of cross-protection against Bordetella holmesii after pertussis vaccination. Emerg Infect Dis. 2012 Nov:18(11):1771-9.

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