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
Aiding in the evaluation of immunodeficiency
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name
Diphtheria Toxoid IgG Ab, SSpecimen Type
SerumSpecimen 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.
Blood Tube Draw Volume
Min 50% draw volume
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 |
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.
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.
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%
Day(s) Performed
Monday through Friday
Report Available
Same day/1 to 4 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterCPT Code Information
86317
NY State Approved
YesForms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.