Tissue Transglutaminase (tTG) Antibody, IgA, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Evaluating patients suspected of having celiac disease, including patients with compatible clinical symptoms, patients with atypical symptoms, and individuals at increased risk (family history, previous diagnosis with associated disorder, positivity for HLA DQ2 and/or DQ8)
Screening test for dermatitis herpetiformis, in conjunction with endomysial antibody test
Monitoring adherence to gluten-free diet in patients with dermatitis herpetiformis and celiac disease
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
The following algorithms are available in Special Instructions:
-Celiac Disease Comprehensive Cascade
-Celiac Disease Diagnostic Testing Algorithm
-Celiac Disease Gluten-Free Cascade
-Celiac Disease Routine Treatment Monitoring Algorithm
-Celiac Disease Serology Cascade
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Tissue Transglutaminase Ab, IgA, S
Tissue Transglutaminase (tTG)
Tissue Transglutaminase Ab IgA
Tissue Transglutaminase (tTG)
Tissue Transglutaminase Ab IgA
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
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
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
Mild OK; Gross OK
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)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Celiac disease (gluten-sensitive enteropathy, celiac sprue) results from an immune-mediated inflammatory process following ingestion of wheat, rye, or barley proteins that occurs in genetically susceptible individuals. The inflammation in celiac disease occurs primarily in the mucosa of the small intestine, which leads to villous atrophy. Common clinical manifestations related to gastrointestinal inflammation include abdominal pain, malabsorption, diarrhea, and constipation. Clinical symptoms of celiac disease are not restricted to the gastrointestinal tract. Other common manifestations of celiac disease include failure to grow (delayed puberty and short stature), iron deficiency, recurrent fetal loss, osteoporosis, chronic fatigue, recurrent aphthous stomatitis (canker sores), dental enamel hypoplasia, and dermatitis herpetiformis. Patients with celiac disease may also present with neuropsychiatric manifestations including ataxia and peripheral neuropathy, and are at increased risk for development of non-Hodgkin lymphoma. The disease is also associated with other clinical disorders including thyroiditis, type I diabetes mellitus, Down syndrome, and IgA deficiency.
Celiac disease tends to occur in families; individuals with family members who have celiac disease are at increased risk of developing the disease. Genetic susceptibility is related to specific HLA markers. More than 97% of individuals with celiac disease in the United States have DQ2 and/or DQ8 HLA markers, compared to approximately 40% of the general population.
A definitive diagnosis of celiac disease requires a jejunal biopsy demonstrating villous atrophy. Given the invasive nature and cost of the biopsy, serologic and genetic laboratory tests may be used to identify individuals with a high probability of having celiac disease. Subsequently, those individuals with positive laboratory results should be referred for small intestinal biopsy, thereby decreasing the number of unnecessary invasive procedures (see Celiac Disease Diagnostic Testing Algorithm in Special Instructions). In terms of serology, celiac disease is associated with a variety of autoantibodies, including endomysial, tissue transglutaminase (tTG), and deamidated gliadin antibodies. Although the IgA isotype of these antibodies usually predominates in celiac disease, individuals may also produce IgG isotypes, particularly if the individual is IgA deficient. The most sensitive and specific serologic tests are tTG and deamidated gliadin antibodies.
The treatment for celiac disease is maintenance of a gluten-free diet. In most patients who adhere to this diet, levels of associated autoantibodies decline and villous atrophy improves. This is typically accompanied by an improvement in clinical symptoms.
See Celiac Disease Diagnostic Testing Algorithm in Special Instructions for the recommended approach to a patient suspected of celiac disease.
An algorithm is available for monitoring the patient's response to treatment, see Celiac Disease Routine Treatment Monitoring Algorithm in Special Instructions.
For your convenience, we recommend utilizing cascade testing for celiac disease. Cascade testing ensures that testing proceeds in an algorithmic fashion. The following cascades are available; select the appropriate 1 for your specific patient situation. Algorithms for the cascade tests are available in Special Instructions.
-CDCOM / Celiac Disease Comprehensive Cascade: complete testing including HLA DQ
-CDSP / Celiac Disease Serology Cascade: complete testing excluding HLA DQ
-CDGF / Celiac Disease Gluten-Free Cascade: for patients already adhering to a gluten-free diet
To order individual tests, see Celiac Disease Diagnostic Testing Algorithm in Special Instructions.
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.
<4.0 U/mL (negative)
4.0-10.0 U/mL (weak positive)
>10.0 U/mL (positive)
Reference values apply to all ages.
The finding of tissue transglutaminase (tTG)-IgA antibodies is specific for celiac disease and possibly for dermatitis herpetiformis. For individuals with moderately to strongly positive results, a diagnosis of celiac disease is likely and the patient should undergo biopsy to confirm the diagnosis.
If patients strictly adhere to a gluten-free diet, the unit value of IgA-anti-tTG should begin to decrease within 6 to 12 months of onset of dietary therapy.
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 solely relied upon to establish a diagnosis of celiac disease. It should be used to identify patients who have an increased probability of having celiac disease and in whom a small intestinal biopsy is recommended.
Affected individuals who have been on a gluten-free diet prior to testing may have a negative result.
For individuals who test negative, IgA deficiency should be considered. If total IgA is normal and tissue transglutaminase (tTG)-IgA is negative, there is a low probability of the patient having celiac disease and a biopsy may not be necessary.
If serology is negative or there is substantial clinical doubt remaining, then further investigation should be performed with endoscopy and bowel biopsy. This is especially important in patients with frank malabsorptive symptoms since many syndromes can mimic celiac disease. For the patient with frank malabsorptive symptoms, bowel biopsy should be performed regardless of serologic test results.
The antibody pattern in dermatitis herpetiformis may be more variable than in celiac disease; therefore, both endomysial and tTG antibody determinations are recommended to maximize the sensitivity of the serologic tests.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Green PH, Cellier C: Celiac disease. N Engl J Med 2007;357:1731-1743
2. Harrison MS, Wehbi M, Obideen K: Celiac disease: More common than you think. Cleve Clinic J Med 2007;74:209-215
3. Rose C, Dieterich W, Brocker EB, et al: Circulating autoantibodies to tissue transglutaminase differentiate patients with dermatitis herpetiformis from those with linear IgA disease. J Am Acad Dermatol 1999;41:957-961
4. Dale JC, Homburger HA, Masoner DE, Murray JA: Update on celiac disease: New standards and new tests. Mayo Communique 2008;33.6:1-9
Method Description Describes how the test is performed and provides a method-specific reference
Microwells are precoated with recombinant human tissue transglutaminase (tTG) antigen, the antigen has been expressed in Baculovirus cells and the expression construct used a cDNA coding for the long spliced isoform of human tTG.
Calibrators, controls, and diluted patient samples are added to the wells and autoantibodies recognizing the tTG antigen bind during the first incubation. After washing the wells to remove all unbound proteins, purified peroxidase-labeled rabbit antihuman IgA (alpha chain specific) conjugate is added. The conjugate binds to the captured human autoantibody and the excess unbound conjugate is removed by a further wash step.
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 the autoantibody in the sample. 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: QUANTA Lite R h-tTG IgA. Inova Diagnostics, Inc. San Diego, CA, 92131)
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 Saturday; 7 a.m.-9 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 has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
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|
|TTGA||Tissue Transglutaminase Ab, IgA, S||46128-5|