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Test Catalog

Test ID: DTABS    
Diphtheria/Tetanus Antibody Panel, Serum

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

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

 

Aids in the evaluation of immunodeficiency

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. Corynebacterium 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 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 greater or equal to 0.01 IU/mL 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 greater or equal to 0.01 IU/mL suggest a vaccine response.

 

A tetanus toxoid booster should strongly be 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 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 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.

 

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 or absence of immunodeficiency.

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 ELISA were also evaluated by the EuroImmun Anti-Diphtheria Toxoid IgG ELISA and results are summarized in the table below.

 

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% Confidence Intervals (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 the table below:

 

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% 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 Recommendations for in-depth reading of a clinical nature

1. Booy R, Aitken SJ, Taylor S, et al: Immunogenicity of combined diphtheria, tetanus, and pertussis vaccine given at 2, 3, and 4 months versus 3, 5, and 9 months of age. Lancet 1992;339(8792):507-510

2. Maple PA, Efstratiou A, George RC, et al: Diphtheria immunity in UK blood donors. Lancet 1995;345(8955):963-965

3. 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

4. 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

5. 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

6. 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

7. Wagner KS, White JM, Lucenko I, et al: Diphtheria in the Postepidemic Period, Europe, 2000-2009. Emerg Infect Dis 2012 Feb;18(2):217-225 doi: 10.3201/eid1802.110987