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Test ID: TTGG
Tissue Transglutaminase (tTG) Antibody, IgG, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

83660

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

Yes

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

For individuals with IgA deficiency:

-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 Comprehensive Cascade for Patients on a Gluten-Free Diet

-Celiac Disease Diagnostic Testing Algorithm

-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

Method Name A short description of the method used to perform the 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, IgG, S

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

Celiac Disease
Coeliac Disease
Tissue Transglutaminase (tTG)
Transglutaminase (tTG)

Specimen Type Describes the specimen type needed for testing

Serum

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.

Container/Tube:

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.

0.4 mL

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

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross OK

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)7 days
 Frozen 14 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.

-CDCOM/89201 Celiac Disease Comprehensive Cascade: complete testing including HLA DQ

-CDSP/89199 Celiac Disease Serology Cascade: complete testing excluding HLA DQ

-CDGF/89200 Celiac Disease Comprehensive Cascade for Patients on a Gluten-Free Diet: for patients already adhering to a gluten-free diet

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.

<6.0 U/mL (negative)

6.0-9.0 U/mL (weak positive)

>9.0 U/mL (positive)

Reference values apply to all ages.

Interpretation Provides information to assist in interpretation of the test results

The finding of tissue transglutaminase (tTG) IgG antibodies may indicate a diagnosis of celiac disease, particularly in individuals who are IgA deficient. For individuals with moderately to strongly positive results, a diagnosis of celiac disease is possible and the patient should undergo a biopsy to confirm the diagnosis.

 

If patients strictly adhere to a gluten-free diet, the unit value of tTG-IgG antibodies should begin to decrease within 6 to 12 months of onset of dietary therapy.

 

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.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Because IgA antibodies typically predominate in celiac disease, testing for tissue transglutaminase (tTG) IgA antibodies is preferred over tTG IgG antibodies, except in the presence of IgA deficiency.

 

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.

 

If serology is negative or there is substantial clinical doubt remaining, then further investigation should be performed with endoscopy and small intestinal 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, small intestinal 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 EMA 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 IgG (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 450nm Microwells are precoated with recombinant human 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. (Package insert: QUANTA Lite R h-tTG IgG. Inova Diagnostics Inc, San Diego, CA, 10/2009)

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; 4 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

4 days

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

7 days

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

Rochester

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.

83516

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 IDReporting NameLOINC Code
TTGGTissue Transglutaminase Ab, IgG, S56537-4