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Test Code BORDG Bordetella pertussis Antibody, IgG, Serum

Useful For

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

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

B. pertussis Ab, IgG, S

Specimen Type

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


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 30 days
  Frozen  30 days

Reject Due To

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

Clinical Information

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

≥100 IU/mL (Positive)

40-<100 IU/mL (Borderline)

<40 IU/mL (Negative)

Reference values apply to all ages.

Interpretation

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

Cautions

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

 Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 

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%

Clinical Reference

1. Leber AL. Pertussis: relevant species and diagnostic update. Clin Lab Med. 2014;34(2):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 Microbiol Infect Dis. 2011;30(3):307-312

3. Andre P, Caro V, Njamkepo E, Wendelboe AM, Van Rie A, Guiso N. 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

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 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)

Day(s) Performed

Thursday

Report Available

Same day/1 to 7 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

CPT Code Information

86615

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BORDG B. pertussis Ab, IgG, S 42330-1

 

Result ID Test Result Name Result LOINC Value
BIGG B. pertussis IgG 29659-0
DEXBG B.pertussis Value 42330-1

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

Secondary ID

64780