Test Catalog

Test Id : BORDG

Bordetella pertussis Antibody, IgG, Serum

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

Diagnosis of recent infection with Bordetella pertussis in patients with symptoms consistent with whooping cough for 2 or more weeks

 

This test should not be used in neonates, young infants or in children between the ages of 4 to 7 years as the routine childhood vaccine schedule may interfere with result interpretation.

 

This test should not be used as a test of cure, to monitor response to treatment, or to determine vaccine status.

Highlights

This test may be used to diagnose recent infection with Bordetella pertussis in patients who have not had the acellular pertussis vaccine or booster in the last 6 months.

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

B. pertussis Ab, IgG, S

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

Whooping cough

B. pertussis infection

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This test should be ordered in patients with 2 or more weeks of symptoms consistent with whooping cough. Nucleic acid amplification testing for Bordetella pertussis should be used in patients who have been symptomatic less than 2 weeks; order BPRP / Bordetella pertussis and Bordetella parapertussis, Molecular Detection, PCR, Varies.

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

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat inactivated Reject

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
Serum Refrigerated (preferred) 30 days
Frozen 30 days

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

Diagnosis of recent infection with Bordetella pertussis in patients with symptoms consistent with whooping cough for 2 or more weeks

 

This test should not be used in neonates, young infants or in children between the ages of 4 to 7 years as the routine childhood vaccine schedule may interfere with result interpretation.

 

This test should not be used as a test of cure, to monitor response to treatment, or to determine vaccine status.

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

Bordetella pertussis, the causative agent of whooping cough, is highly contagious and remains endemic in the United States despite the high rate of vaccination. Acute B pertussis infections are typically diagnosed by culture or nucleic acid amplification testing (NAAT). However, symptomatic adults and adolescents often seek medical attention later in the course of infection, at which time the sensitivity of these 2 methods to detect the infectious agent decreases. A serologic response to B pertussis is typically mounted 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.

 

Prior to testing, providers should review whether the patient was recently vaccinated using the Tdap (Tetanus-Diphtheria-acellular Pertussis) or DTap vaccines. The acellular pertussis vaccine contains 1 to 5 B pertussis antigens, including filamentous hemagglutinin, pertactin, 2 fimbrial agglutinogens, and significant levels of PT. Therefore, recent vaccination for B pertussis, specifically within the last 2 to 6 months, may lead to a positive result by the anti-PT IgG assay, and knowledge of the patient's vaccination history is important for accurate result interpretation.

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.

> or =100 IU/mL (positive)

> or = 40-<100 IU/mL (borderline)

<40 IU/mL (negative)

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Negative (<40 IU/mL): No IgG antibodies to pertussis toxin (PT) detected. Results may be falsely negative in patients with less than 2 weeks of symptoms.

 

Borderline (40-<100 IU/mL): Recommend follow-up testing in 10 to 14 days if clinically indicated.

 

Positive (> or =100 IU/mL): IgG antibodies to pertussis toxin (PT) detected. Results suggest recent infection with or recent vaccination against Bordetella pertussis.

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

Immune response following vaccination cannot be distinguished from recent infection.

 

For diagnosis, clinical symptoms, the patient's age and vaccination history should always be taken into account along with the serological results.

 

Whooping cough caused by Bordetella parapertussis will not be detected by this assay.

 

The Centers for Disease Control and Prevention recommend nucleic acid amplification tests (NAAT) or culture as first-line tests for B pertussis infection. However, serologic testing may be useful in patients who are symptomatic for more than 2 weeks.

Supportive Data

Accuracy:

A total of 108 previously characterized serum samples (originally tested by Focus Diagnostics Inc.) were evaluated by the EuroImmun antipertussis toxin (PT) IgG EIA and the results are indicated below.

 

Comparison of the EuroImmun and Focus Diagnostics Bordetella pertussis PT EIAs

                       

Focus Diagnostics PT EIA

Positive

Negative

EuroImmun PT EIA

Positive

18

0

Negative

0

77

Borderline(a)

8(b)

5(c)

 

 

 

 

 

 

 

 

 

(a)Testing of a convalescent sample is recommended. Samples not included in positive and negative agreement calculations below.

(b) All 8 samples had low positive values by the Focus assay.

(c) All 5 samples were near the lower end of the borderline range for the EuroImmun ELISA.

 

Positive Agreement: 100% (18/18); 95% CI: 79.3%-100%

Negative Agreement: 100% (77/77); 95% CI: 94.3%-100%

Overall Agreement: 95.4% (95/108); 95% CI: 80.4%-93.0%

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

1. Leber AL: Pertussis: relevant species and diagnostic update. Clin Lab Med. 2014;34:237-255

2. Guiso N, Berbers G, Fry NK, et al: What to do and what not to do in serological diagnosis of pertussis: recommendation from EU reference laboratories. Eur J Clin Microbiolo Infect Dis. 2011;30(3):307-312

3. Andre P, Caro V, Njamkepo E, et al: Comparison of serological and real-time PCR assays to diagnose Bordetella pertussis infection in 2007. J Clin Microbiol. 2008;46(5):1672-1677

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

The antipertussis toxin (PT) IgG enzyme-linked immunosorbent assay (ELISA) test is a quantitative assay. Microtiter wells are coated with PT from Bordetella pertussis and diluted patient samples, calibrators, and controls are incubated in the wells. If present, antibodies to Bordetella pertussis will bind to the antigen. After wells are washed, enzyme-labeled antihuman IgG is added, and wells are incubated a second time. After incubation, wells are washed and a tetramethylbenzidine (TMB) chromogen/substrate solution is added and wells are incubated. Stop solution is added to stop the reaction. Wells are read using a microplate reader with 450/620 nm wavelength. Calibrator values are plotted to make a point-to-point standard curve. Sample antibody concentrations are determined using the standard curve.(Package insert: Anti-Bordetella pertussis toxin ELISA (IgG) Test Instructions. EUROIMMUN US; 03/05/2019)

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.

Thursday

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.

Same day/1 to 7 days

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

14 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.

86615

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