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Epic Code LAB1230507 Diphtheria Toxoid IgG Antibody, Serum

Additional Codes

Mayo Code: DIPGS

Interface Code: 1230507

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Determining a patient's immunological response to diphtheria toxoid vaccination

 

Aiding in the evaluation of immunodeficiency

Specimen Type

Serum


Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


Laboratory Test Directory Note:

COLLECTION NOTE: Volumes listed are in serum or plasma, draw approximately 2 1/2 times the requested volume in whole blood.

Specimen Minimum Volume

0.4 mL

Forms

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

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

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.

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.

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Report Available

Same day/1 to 4 days

Reporting Name

Diphtheria Toxoid IgG Ab, S

Reference Values

Vaccinated: Positive (≥0.01 IU/mL)

Unvaccinated: Negative (<0.01 IU/mL)

Reference values apply to all ages.

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.

Method Description

The EuroImmun Anti-Diphtheria Toxoid IgG enzyme-linked immunosorbent assay (ELISA) kit provides a quantitative in vitro assay for detection of 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-labelled antihuman IgG (enzyme conjugate) catalyzing a color reaction.(Package insert: Anti-Diphtheria Toxoid ELISA [IgG] Test Instructions, EUROIMMUN US; 09/13/2017)

Day(s) Performed

Monday through Friday

Clinical Reference

1. Booy R, Aitken SJ, Taylor S, et al: Immunogenicity of combined diphtheria, tetanus, and pertussis vaccine given at 2, 3, and 4 months versus 3, 5, and 9 months of age. Lancet. 1992;339(8792):507-510

2. Maple PA, Efstratiou A, George RC, Andrews NJ, Sesardic D: Diphtheria immunity in UK blood donors. Lancet. 1995;345(8955):963-965

3. WHO meeting report: The Control of Diphtheria in Europe. WHO ref:EUR/ICP/EPI/024 1990

4. Wagner KS, White JM, Lucenko I, et al: Diphtheria in the postepidemic period, Europe, 2000-2009. Emerg Infect Dis. 2012 Feb;18(2):217-225 doi: 10.3201/eid1802.110987

Test Classification

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

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