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Epic Test Code LAB792 Diphtheria Toxoid IgG Antibody, Serum

Additional Codes

MML Code: DIPGS

 

Useful For

Determining a patient's immunological response to diphtheria toxoid vaccination

 

Aids in the evaluation of immunodeficiency

Method Name

Enzyme Immunoassay (EIA)

Reporting Name

Diphtheria Toxoid IgG Ab, S

Specimen Type

Serum


Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


Bassett Healthcare Network Clinical Laboratories Note:

Blood Tube Draw Volume
Min 50% draw volume  

Specimen Minimum Volume

0.4 mL

Specimen Stability Information

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

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

NA

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. Corynebacterium 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.

Reference Values

Vaccinated: Positive (≥0.01 IU/mL)

Unvaccinated: Negative (<0.01 IU/mL)

Reference Values apply to all ages.

Interpretation

Results ≥0.01 IU/mL 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 ELISA were also evaluated by the EuroImmun Anti-Diphtheria Toxoid IgG ELISA and results are summarized in the table below:

 

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

2011

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% Confidence Intervals (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%

Day(s) and Time(s) Performed

Monday through Friday; 9 a.m.

Analytic Time

Same day/1 day

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86317

NY State Approved

Yes

Forms

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