Test Catalog

Test Id : TTIGS

Tetanus Toxoid IgG Antibody, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
A short description of the method used to perform the test

Enzyme Immunoassay (EIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Tetanus Toxoid IgG Ab, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti-tetanus toxoid

Clostridium tetani

Tetanus Immune Response

Tetanus toxoid antibodies

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.4 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Vaccinated: Positive (> or =0.01 IU/mL)

Unvaccinated: Negative (<0.01 IU/mL)

Interpretation
Provides information to assist in interpretation of the test results

Results greater than or equal to 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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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 enzyme-linked immunosorbent assay (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% 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
Recommendations for in-depth reading of a clinical nature

1. Boland Birch T, Bleck TP: Tetanus (Clostridium tetani). In Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020:2948-2953

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
Describes how the test is performed and provides a method-specific reference

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; 08/18/2017)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86317

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports