Test Catalog

Test Id : DTABS

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Diphtheria/Tetanus Antibody Panel, Serum

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Overview

Test Catalog

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

Assessing 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
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

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
A short description of the method used to perform the test

Enzyme-Linked Immunosorbent Assay (ELISA)

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

Diphtheria/Tetanus Ab Panel, S

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

Anti-tetanus toxoid

C. tetani

Clostridium tetani

Corynebacterium diphtheriae Antitoxin

Diphtheria Antitoxoid

Tetanus Immune Response

Tetanus toxoid antibodies

Tetanus/Diphtheria Antibody Panel

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

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

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

0.8 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
Heat Inactivated specimen 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

Assessing 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

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

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.

 

 

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 where it blocks inhibitory impulses to motor neurons and leads to severe, spastic muscle contractions, a classic characteristic of tetanus.

 

Both diseases are preventable by vaccination with diphtheria toxoid, which stimulates antidiphtheria toxoid antibodies, and tetanus toxoid (formaldehyde-treated tetanospasmin), which stimulates development of antitetanus toxoid antibodies. In the United States, these toxoids are 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 antidiphtheria toxoid IgG antibody and total antitetanus toxoid IgG antibody levels in serum. An absence of either 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.

DIPHTHERIA TOXOID IgG ANTIBODY

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

Unvaccinated: Negative (<0.01 IU/mL)

Reference values apply to all ages.

 

TETANUS TOXOID IgG ANTIBODY

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

Unvaccinated: Negative (<0.01 IU/mL)

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Diphtheria:

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.

 

Tetanus:

Results of 0.01 IU/mL or more suggest a vaccine response.

 

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

 

Some cases of tetanus, usually mild, have occasionally been observed in patients with 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 assay does not provide diagnostic proof of lack of protection against diphtheria and tetanus 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.

Supportive Data

Diphtheria:

A total of 211 serum samples prospectively submitted to our reference laboratory for routine testing for antidiphtheria toxoid IgG antibodies by the Binding Site Anti-Diphtheria Toxoid IgG enzyme-linked immunosorbent assay (ELISA) were also evaluated by the EuroImmun Anti-Diphtheria Toxoid IgG ELISA and results are summarized in Table 1.

 

Table 1. Comparison of the EuroImmun and Binding Site Anti-Diphtheria Toxoid IgG ELISAs

 

Binding Site IgG ELISA

 

Positive

Negative

Total

EuroImmun IgG ELISA

Positive

206

0

206

Negative

4(a)

1

5

 

Total

210

1

2011

a) 1 of 4 samples tested positive by the ARUP Quantitative Multiplex Bead assay for antidiphtheria toxoid IgG

% Positive Agreement: 98.1% (206/210); 95% CI: 95.0-99.4%

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

% Overall Agreement: 98.1% (207/211); 95% CI: 95.1-99.4%

 

Tetanus:

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 Table 2:

 

Table 2. 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. Bleck TP: Clostridium tetani (tetanus). In: Mandell GL, Bennett JE, Dolin R, eds. Principals and Practice of Infectious Disease. 5th ed. Churchill Livingstone; 2000:2537-2543

2. Gergen PJ, McQuillan GM, Kiely M, Ezzati-Rice TM, Sutter RW, Virella G: A population-based serologic survey of immunity to tetanus in the United States. N Engl J Med. 1995 Mar;332(12):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(4):471-475

4. Ramsay ME, Corbel MJ, Redhead K, Ashworth LA, Begg NT: Persistence of antibody after accelerated immunization with diphtheria/tetanus/pertussis vaccine. Br Med J. 1991 Jun;302(6791):1489-1491

5. 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 October 27, 2022. Available at www.cdc.gov/diphtheria/index.html

6. Truelove SA, Keegan LT, Moss WJ, et al: Clinical and epidemiological aspects of diphtheria: a systematic review and pooled analysis. Clin Infect Dis. 2020 Jun;71(1):89-97

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

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-labeled 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)

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 x 2

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
DTABS Diphtheria/Tetanus Ab Panel, S In Process
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
TETG Tetanus IgG Ab 33469-8
DEXTG Tetanus IgG Value 53935-3
DIPG Diphtheria IgG Ab 45166-6
DEXDP Diphtheria IgG Value 48654-8

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