Test Catalog

Test Id : BPRP

Bordetella pertussis and Bordetella parapertussis, Molecular Detection, PCR, Varies

Useful For
Suggests clinical disorders or settings where the test may be helpful

Preferred diagnostic test for the detection of Bordetella pertussis or Bordetella parapertussis

Method Name
A short description of the method used to perform the test

Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

Includes DNA preparation from specimen, PCR amplification, and hybridization

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Bordetella PCR

Aliases
Lists additional common names for a test, as an aid in searching

Bordetella pertussis and parapertussis

Parapertussis

PCR (Polymerase Chain Reaction)

Pertussis

Polymerase Chain Reaction (PCR)

Whooping Cough

Bordetella parapertussis by PCR

Bordetella parapertussis by Rapid PCR

Bordetella pertussis Detection by Polymerase Chain Reaction (PCR)

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

The high sensitivity of amplification by PCR requires the specimen to be processed in an environment in which contamination of the specimen by Bordetella pertussis or Bordetella parapertussis DNA is unlikely.

 

Submit only 1 of the following specimens:

 

Preferred:

Supplies:

Nasopharyngeal Swab (Rayon Mini-Tip Swab) (T515)

Specimen Type: Nasopharyngeal swab

Container/Tube: Rayon swab with an aluminum shaft placed in transport medium such as a green-top nasopharyngeal swab (rayon mini-tip) with Stuart's media (no charcoal) (T515), or Stuart's with charcoal, or Amies with or without charcoal (Transwab Nasopharyngeal with Charcoal System).

Additional Information:

1. Swab transport containers without charcoal must contain a pledget saturated with either Stuart's or Amies liquid media. Clear semi-solid/solid media is gel and will be rejected.

2. Other swab or media types may be inhibitory to PCR testing and will be rejected.

 

Acceptable:

Specimen Type: Nasopharyngeal (not throat) aspirate/wash or nasal aspirate/wash

Container/Tube: Sterile container with a screw top cap (no transport media)

Specimen Volume: Entire collection

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Other Nose, nasal, or throat swab; calcium alginate or cotton-tipped swab; swab sent in gel transport medium, viral/universal transport medium, or Regan Lowe media; ESwab; swabs with solid plastic shaft; dry swab

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 7 days
Ambient 7 days
Frozen 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Preferred diagnostic test for the detection of Bordetella pertussis or Bordetella parapertussis

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Bordetella pertussis is the highly contagious etiological agent of pertussis or whooping cough. Bordetella parapertussis causes a similar, but generally less severe illness. Despite vaccination efforts, B pertussis remains common in the United States, underscoring the need for effective diagnostic tests. In the United States, pertussis is most common in the late summer months. Pertussis vaccination does not prevent B parapertussis infection, which generally occurs in a younger age group than disease caused by B pertussis. Diagnosis of pertussis is based on having a high clinical index of suspicion for the infection, along with confirmation by laboratory testing. Laboratory testing methods include nucleic acid amplification tests (eg, PCR), serology, culture and direct fluorescent antibody testing. Culture and direct fluorescent antibody testing are limited by low sensitivity, rendering nucleic acid amplification tests and serology the tests of choice.

 

The Centers for Disease Control and Prevention recommends PCR testing for patients suspected of having acute pertussis. B pertussis PCR detects roughly twice as many cases as culture. B pertussis DNA can be detected up to 4 weeks, or longer (up to 8 weeks in our experience),(1) after symptom onset. However, over time, the amount of B pertussis and B parapertussis DNA will diminish, rendering the assay less sensitive. A serologic response to B pertussis is typically mounted by 2 weeks following infection and, therefore, detection of IgG-class antibodies to pertussis toxin (PT), which is only produced by B pertussis, can be a useful adjunct for diagnosis at later stages of illness at a time when the amount of B pertussis may be below the limit of detection of the PCR assay.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Not applicable

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates the presence of DNA from Bordetella pertussis or B parapertussis. In some cases, a patient may test positive for both B pertussis and B parapertussis. Cross-reactivity with B holmesii and B bronchiseptica may occur with the B pertussis assay (see Cautions).

 

A negative result indicates the absence of detectable B pertussis and B parapertussis DNA in the specimen but does not negate the presence of organism or active or recent disease (known inhibition rate of <1%) and may occur due to inhibition of PCR, sequence variability underlying primers and/or probes, or the presence of B pertussis or B parapertussis in quantities less than the limit of detection of the assay. Additionally, patients presenting late after symptom onset may test negative; in such cases, testing for B pertussis antibody, IgG, in serum may be considered.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Cross-reactivity with Bordetella holmesii may occur with the B pertussis PCR assay. The prevalence of B holmesii is relatively low, with positivity in <1% of nasopharyngeal swabs.(2) Please note that B holmesii has been associated with pertussis-like symptoms.(2)

 

Cross-reactivity of the B pertussis assay has been demonstrated with a limited number of Bordetella bronchiseptica isolates. The prevalence of the insertion sequence target, IS481, has been reported to be between 1% and 5% in B bronchiseptica isolates. 

 

This assay is not recommended for screening asymptomatic individuals who may carry B pertussis or parapertussis.

 

This assay is not recommended for follow up of patients previously diagnosed with pertussis (ie, as a test of cure).

 

Some B pertussis acellular vaccines (ie, Pentacel, Daptacel, Adacel) contain PCR detectable DNA. Contamination of specimens with vaccine can cause false-positive B pertussis PCR results. Specimens should not be collected or processed in areas that are exposed to B pertussis vaccine material.

Supportive Data

The assay targets the multicopy insertion gene sequences, IS481 and IS1001, of Bordetella pertussis and Bordetella parapertussis, respectively. This assay was previously performed using analyte specific reagents from Roche Diagnostics(3); these reagents are no longer available. The assay was revalidated using probes and primers with the same sequence, but provided by an alternate vendor. Performance of the new assay was then compared to the previous assay, which used the Roche analyte specific reagents, using 374 nasopharyngeal swabs and washings submitted for Bordetella testing. Fifty-four specimens were positive (48 Bordetella pertussis and 6 Bordetella parapertussis) and 314 specimens were negative by both assays. Five nasopharyngeal specimens were positive for Bordetella pertussis or Bordetella parapertussis by the new assay and negative by the old assay. One nasopharyngeal specimen was positive for Bordetella pertussis by the old assay but negative by the new assay. Overall, there was 98% (368/374) agreement between the 2 assays. Bordetella holmesii cannot be distinguished from Bordetella pertussis by the assay. The analytical sensitivity of the assay is 1 target/mcL for nasopharyngeal swabs and 10 targets/mcL for nasopharyngeal wash/aspirates.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Theofiles AG, Cunningham SA, Chia N, et al: Pertussis outbreak, southeastern Minnesota, 2012. Mayo Clin Proc 2014 Oct;89(10):1378-1388

2. Guthrie JL, Robertson AV, Tang P, et al: Novel duplex real-time PCR assay detects Bordetella holmesii in specimens from patients with pertussis-like symptoms in Ontario, Canada. J Clin Microbiol 2010;48:1435-1437

3. Sloan LM, Hopkins MK, Mitchell PS, et al: Multiplex LightCycler PCR assay for detection and differentiation of Bordetella pertussis and Bordetella parapertussis in nasopharyngeal specimens. J Clin Microbiol 2002;40:96-100

Method Description
Describes how the test is performed and provides a method-specific reference

The LightCycler instrument platform amplifies and monitors the development of target nucleic acid sequences by fluorescence after each cycle of PCR. The automated detection of amplified products is based on the fluorescence resonance energy transfer (FRET) principle. The assay uses the repetitive (50-100 copies) insertion sequence (IS481) found in Bordetella pertussis and the repetitive (35-50 copies) insertion sequence (IS1001) found in B parapertussis as targets. Detection and differentiation of Bordetella targets is performed through melting curve analysis. The probes were designed to obtain a 10 degree C temperature shift between B pertussis and B parapertussis that is seen in the melting curve analysis. Analysis of the PCR amplification and probe melting curves is accomplished through the use of the LightCycler software.(Sloan LM, Hopkins MK, Mitchell PS, et al: Multiplex LightCycler PCR assay for detection and differentiation of Bordetella pertussis and Bordetella parapertussis in nasopharyngeal specimens. J Clin Microbiol 2002;40:96-100)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday, Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

3 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87798 x 2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports