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Test Code DITET / DTABS-M Diphtheria/Tetanus Antibody Panel, Serum

Additional Codes

Software Test Code
SoftID DITET
EPIC LAB20177
Mayo Laboratories DTABS

Useful For

Assessment of an antibody response to tetanus and diphtheria toxoid vaccines, which should be performed at least 3 weeks after immunization

 

Aiding in the evaluation of immunodeficiency

 

This test should not be used to diagnose tetanus infection

Profile Information

Test ID Reporting Name Available Separately Always Performed
DIPGS Diphtheria Toxoid IgG Ab, S Yes Yes
TTIGS Tetanus Toxoid IgG Ab, S Yes Yes

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Diphtheria/Tetanus Ab Panel, S

Specimen Type

Serum


Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL


Specimen Minimum Volume

0.8 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, 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.

 

Tetanus results from contamination of wounds or lacerations with Clostridium tetani spores from the environment. The spores germinate to actively replicating bacterial cells localized within the wound and produce the heat-labile toxin, tetanospasmin. Tetanospasmin attaches to peripheral nerve endings and travels to the central nervous system (CNS) where it blocks inhibitory impulses to motor neurons and leads to severe, spastic muscle contractions, a classic characteristic of tetanus.

 

The disease is preventable by vaccination with tetanus toxoid (formaldehyde-treated tetanospasmin), which stimulates development of antitetanus toxoid antibodies. In the United States, tetanus toxoid is administered to children as part of the combined diphtheria, tetanus, acellular pertussis (TDaP) vaccine.

 

Two to 3 weeks following vaccination, a patient's immunological response may be assessed by measuring the total antitetanus toxoid IgG antibody level in serum. An absence of antibody formation postvaccination may relate to immune deficiency disorders, either congenital or acquired, or iatrogenic due to immunosuppressive drugs.

Reference Values

DIPHTHERIA TOXOID IgG ANTIBODY

Vaccinated: Positive (≥0.01 IU/mL)

Unvaccinated: Negative (<0.01 IU/mL)

Reference values apply to all ages.

 

TETANUS TOXOID IgG ANTIBODY

Vaccinated: Positive (≥0.01 IU/mL)

Unvaccinated: Negative (<0.01 IU/mL)

Reference values apply to all ages.

Cautions

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

 

The diagnosis of tetanus is by clinical observation. A positive wound culture for the agent of tetanus, Clostridium tetani, may support, but does not confirm, the diagnosis. Toxin assays for tetanospasmin may be useful but are only available in a few laboratories.

 

The results obtained from this assay are not diagnostic proof of lack of protection against tetanus or the presence or absence of immunodeficiency.

Method Description

The EuroImmun Anti-Diphtheria Toxoid enzyme-linked immunosorbent assay (ELISA)and Anti-Tetanus Toxoid ELISA provide quantitative in-vitro assays for detection of human IgG-class antibodies to diphtheria and tetanus toxoid, respectively.

 

The test kits contain reagent wells coated with either diphtheria or tetanus 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 inserts: Anti-Tetanus Toxoid ELISA [IgG] Test instruction. 08/28/2017; Anti-Diphtheria Toxoid ELISA [IgG] Test instruction. EUROIMMUN US;08/18/2017)

Day(s) Performed

Monday through Friday

Report Available

Same day/1 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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 x 2

LOINC Code Information

Test ID Test Order Name Order LOINC Value
DTABS Diphtheria/Tetanus Ab Panel, S In Process

 

Result ID Test Result Name Result LOINC Value
TETG Tetanus IgG Ab 33469-8
DIPG Diphtheria IgG Ab 45166-6
DEXDP Diphtheria IgG Value 48654-8
DEXTG Tetanus IgG Value 53935-3

Forms

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

Secondary ID

36670