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Test Code DIPGS Diphtheria Toxoid IgG Antibody, Serum

Reporting Name

Diphtheria Toxoid IgG Ab, S

Useful For

Determining a patient's immunological response to diphtheria toxoid vaccination

 

Aiding in the evaluation of immunodeficiency

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


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: 0.5 mL

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


Specimen Minimum Volume

0.4 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 specimen Reject

Reference Values

Vaccinated: Positive (≥0.01 IU/mL)

Unvaccinated: Negative (<0.01 IU/mL)

Reference values apply to all ages.

Day(s) Performed

Monday through Friday

CPT Code Information

86317

LOINC Code Information

Test ID Test Order Name Order LOINC Value
DIPGS Diphtheria Toxoid IgG Ab, S 48654-8

 

Result ID Test Result Name Result LOINC Value
DIPG Diphtheria IgG Ab 45166-6
DEXDP Diphtheria IgG Value 48654-8

Clinical Information

Diphtheria is an acute, contagious, febrile illness caused by the bacterium Corynebacterium diphtheriae. The disease is classically characterized by a combination of localized inflammation in the upper respiratory tract with the formation of a diphtheric pseudomembrane over the oropharynx, including the tonsils, pharynx, larynx, and posterior nasal passages. C diphtheriae produces a potent diphtheria exotoxin that is absorbed systemically and can lead to cardiac failure and paralysis of the diaphragm.

 

The disease is preventable by vaccination with diphtheria toxoid, which stimulates antidiphtheria toxoid antibodies. In the United States, diphtheria toxoid is administered to children as part of the combined diphtheria, tetanus, and acellular pertussis (TDaP) vaccine. A patient's immunological response to diphtheria toxoid vaccination can be determined by measuring antidiphtheria toxoid IgG antibody using this enzyme immunoassay technique. An absence of antibody formation postvaccination may relate to immune deficiency disorders, either congenital or acquired, or iatrogenic due to immunosuppressive drugs.

Interpretation

Results of 0.01 IU/mL or more suggest a vaccine response.

 

A diphtheria toxoid booster should be considered for patients with antidiphtheria toxoid IgG values between 0.01 and less than 0.1 IU/mL.

Cautions

This assay does not provide diagnostic proof of lack of protection against diphtheria or the presence of absence of immunodeficiency. Results must be confirmed by clinical findings and other serological tests.

Supportive Data

A total of 211 serum samples prospectively submitted to our reference laboratory for routine testing for antidiphtheria toxoid IgG antibodies by the Binding Site Anti-Diphtheria Toxoid IgG enzyme-linked immunosorbent assay (ELISA) were also evaluated by the EuroImmun Anti-Diphtheria Toxoid IgG ELISA and results are summarized in the table:

 

Table. Comparison of the EuroImmun and Binding Site Anti-Diphtheria Toxoid IgG ELISAs

 

Binding Site IgG ELISA

 

Positive

Negative

Total

EuroImmun IgG ELISA

Positive

206

0

206

Negative

4(a)

1

5

 

Total

210

1

211

a) 1 of 4 samples tested positive by the ARUP Quantitative Multiplex Bead assay for antidiphtheria toxoid IgG

% Positive Agreement: 98.1% (206/210); 95% CI: 95.0-99.4%

% Negative Agreement: 100% (1/1); 95% CI: 16.8-100%

% Overall Agreement: 98.1% (207/211); 95% CI: 95.1-99.4%

Clinical Reference

1. Centers for Disease Control and Prevention (CDC); National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases. Diphtheria. CDC; Updated September 9, 2022. Accessed September 5, 2024. Available at www.cdc.gov/diphtheria/index.html

2. Truelove SA, Keegan LT, Moss WJ, et al. Clinical and epidemiological aspects of diphtheria: a systematic review and pooled analysis. Clin Infect Dis. 2020;71(1):89-97

Method Description

The Anti-Diphtheria Toxoid IgG enzyme-linked immunosorbent assay provides a quantitative in vitro assay for detecting human IgG-class antibodies to diphtheria toxoid. The test kit contains reagent wells coated with diphtheria toxoid. In the first reaction step, diluted patient samples are incubated in the wells. In the case of positive samples, specific IgG antibodies will bind to the antigens. To detect the bound antibodies, a second incubation is carried out using an enzyme-labeled antihuman IgG (enzyme conjugate), catalyzing a color reaction.(Unpublished Mayo method)

Report Available

Same day/1 to 4 days

Specimen Retention Time

14 days

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.

Forms

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

Secondary ID

36664