Tetanus Toxoid IgG Antibody Assay, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Assessment of an antibody response to tetanus toxoid vaccine
May be used to aid diagnosis of immunodeficiency
Enzyme Immunoassay (EIA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Tetanus Toxoid IgG Ab, S
Tetanus Immune Response
Tetanus toxoid antibodies
Tetanus Immune Response
Tetanus toxoid antibodies
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Tetanus is a nervous system disease characterized by severe muscle spasms caused by the toxin tetanospasmin that is produced by Clostridium tetani organisms. The disease is preventable by vaccination with tetanus toxoid (formaldehyde-treated tetanospasmin). Tetanus toxoid is an excellent immunogen; it stimulates development of antitetanus toxoid antibodies.
Subsequent to vaccination, a patient's immunological response may be assessed by determining the presence of tetanus toxoid antibody levels in the serum. An absence of antibody formation postvaccination may relate to immune deficiency disorders, either congenital, 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.
The minimum level of protective antibody in the normal population is between 0.01 and 0.15 IU/mL. The majority of vaccinated individuals should demonstrate protective levels of antibody >0.15 IU/mL.
Results > or =0.16 IU/mL suggest a vaccine response.
Some cases of tetanus, usually mild, occasionally have 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/protection against tetanus, or the presence/absence of immunodeficiency.
Several studies were performed to determine minimum protective levels of tetanus toxoid antibody. The results suggest that minimal protective levels range from 0.01 IU/mL to 0.15 IU/mL, depending on the study. The largest of these studies conducted in the United States involved a sample population of 10,618 individuals, ranging from age 6 upwards. Overall, 69.7% had levels of >0.15 IU/mL: the rate decreased from 87.7% in 6 to 11 year olds to 27.8% in those 70 years of age and older. At Mayo, 100 normal donor sera were tested. Of these, 98% had antibody levels of >0.15 IU/mL, and 100% had levels of >0.01 IU/mL.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Bleck TP: Clostridium tetani (tetanus). In Principals and Practice of Infectious Disease. 5th 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 Describes how the test is performed and provides a method-specific reference
The VaccZyme Anti-Tetanus Toxoid IgG Enzyme Immunoassay Kit detects antibody to tetanus toxoid and is a conventional immunoassay technique. Microwells are precoated with tetanus toxoid antigen. The calibrators, controls, and diluted patient specimens are added to the wells and antibodies recognizing the tetanus toxoid antigen bind during the first incubation. After washing the wells to remove all unbound proteins, purified peroxidase-labeled rabbit antihuman IgG (y-chain specific) conjugate is added. The conjugate binds to the captured human antibody and the excess unbound conjugate is removed by a further wash step. The bound conjugate is visualized with 3,3', 5,5' tetramethylbenzidine substrate, which gives a blue reaction product, the intensity of which is proportional to the concentration of antibody in the specimen. Phosphoric acid is added to each well to stop the reaction. This produces a yellow end point color which is read at 450 nm. (Package insert: VaccZyme Anti-Tetanus Toxoid IgG Enzyme Immunoassay Kit. The Binding Site Ltd., UK, Birmingham, England)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 3 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test uses a reagent or kit labeled by the manufacturer as Research Use Only. Its performance characteristics were 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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|TTIG||Tetanus Toxoid IgG Ab, S||53935-3|