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HelpEpic 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
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.
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
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 |
Day(s) Performed
Monday through Friday
Reference Values
Vaccinated: Positive (≥0.01 IU/mL)
Unvaccinated: Negative (<0.01 IU/mL)
Reference values apply to all ages.
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.
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.
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.
Reporting Name
Diphtheria Toxoid IgG Ab, SMethod Name
Enzyme-Linked Immunosorbent Assay (ELISA)
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)
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 |
Report Available
Same day/1 to 4 daysTest 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.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
Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.