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Test Code TTIG (TTIGS) Tetanus Toxoid IgG Antibody, Serum

Useful For

Assessment of an antibody response to the tetanus toxoid vaccine, which should be performed at least 3 weeks after immunization

 

An aid to diagnose immunodeficiency

Method Name

Enzyme Immunoassay (EIA)

Reporting Name

Tetanus Toxoid IgG Ab, S

Specimen Type

Serum


Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


Specimen Minimum Volume

0.4 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis

Reject

Gross lipemia

Reject

Gross icterus

Reject

Clinical Information

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, and 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

Vaccinated: Positive (≥0.01 IU/mL)

Unvaccinated: Negative (<0.01 IU/mL)

Interpretation

Results ≥0.01 suggest a vaccine response.

 

A tetanus toxoid booster should strongly be considered for patients with anti-tetanus toxoid IgG values between 0.01 and 0.5 IU/mL.

 

Some cases of tetanus, usually mild, have occasionally been observed in patients who have a measurable serum level of 0.01 to 1.0 IU/mL.

Cautions

This test should not be used to diagnose tetanus infection. 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/absence of immunodeficiency.

Supportive Data

A total of 227 serum samples prospectively submitted to our laboratory for routine antitetanus toxoid IgG testing by the Binding Site Anti-Tetanus Toxoid IgG ELISA were also evaluated by the EuroImmun Anti-Tetanus Toxoid IgG ELISA. Results are summarized in the table below:

 

Comparison of the EuroImmun and Binding Site Anti-Tetanus Toxoid IgG ELISAs

 

Binding Site IgG ELISA

 

Positive

Negative

Total

EuroImmun IgG ELISA

Positive

220

0

220

Negative

6(a)

1

7

 

Total

226

1

227

a) 3 of the 6 samples tested positive by the anti-Tetanus Toxoid IgG Quantiative Multiplex Bead Assay at ARUP.

% Positive Agreement: 97.4% (220/226); 95% Confidence Interval (95% CI): 94.2-98.9%

% Negative Agreement: 100% (1/1); 95% CI: 16.8-100%

% Overall Agreement: 97.4% (221/227); 95% CI: 94.2-98.9%

Clinical Reference

1. Bleck TP: Clostridium tetani (tetanus). In Principals and Practice of Infectious Disease. Fifth edition. Edited by GL Mandell, JE Bennett, R Dolin. Churchill Livingstone, Philadelphia, 2000, pp 2537-2543

2. Gergen PJ, McQuillan GM, Kiely M, et al: A population-based serologic survey of immunity to tetanus in the United States. N Engl J Med 1995;332:761-766

3. Bjorkholm B, Wahl M, Granstrom M, Hagberg L: Immune status and booster effects of low doses of tetanus toxoid in Swedish medical personnel. Scand J Infect Dis 1994;26:471-475

4. Ramsay ME, Corbel MJ, Redhead K, et al: Persistence of antibody after accelerated immunization with diptheria/tetanus/pertussis vaccine. Br Med J 1991;302:1489-1491

5. Rubin RL, Tang FL, Chan EK, et al: IgG subclasses of autoantibodies in systemic lupus erythematosus. Sjogren's syndrome, and drug-induced autoimmunitiy. J Immunol 1986;137:2522-2527

6. Simonsen O, Bentzon MW, Heron I: ELISA for the routine determination of antitoxic immunity to tetanus. J Biol Stand 1986;14:231-239

Method Description

The EuroImmun Anti-Tetanus Toxoid ELISA provides a quantitative in-vitro assay for detection of human IgG-class antibodies to Tetanus toxoid. The test kit contains reagent wells coated with 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 anti-human IgG (enzyme conjugate) catalyzing a color reaction.(Package insert: Anti-Tetanus Toxoid ELISA (IgG) Test instruction, EuroImmun US, Morris Plains, New Jersey 02/25/2016)

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

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 U.S. Food and Drug Administration.

CPT Code Information

86317

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TTIGS Tetanus Toxoid IgG Ab, S 53935-3

 

Result ID Test Result Name Result LOINC Value
TETG Tetanus IgG Ab 33469-8
DEXTG Tetanus IgG Value 53935-3

NY State Approved

Yes

Forms

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