Test Catalog

Test Id : DGGL

Gliadin (Deamidated) Antibody, IgG, Serum

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

Evaluating patients suspected of having celiac disease; this includes patients with symptoms compatible with celiac disease, patients with atypical symptoms, and individuals at increased risk of celiac disease

 

Evaluating the response to treatment with a gluten-free diet

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Gliadin(Deamidated) Ab, IgG, S

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

Celiac Disease

Coeliac Disease

Gliadin Antibodies IgG

Gliadin IgG, Serum

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

Cascade testing is recommended for celiac disease. Cascade testing ensures that testing proceeds in an algorithmic fashion. The following cascades are available; select the appropriate one for your specific patient situation.

-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.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.

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

0.4 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 OK

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) 21 days
Frozen 21 days

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

Evaluating patients suspected of having celiac disease; this includes patients with symptoms compatible with celiac disease, patients with atypical symptoms, and individuals at increased risk of celiac disease

 

Evaluating the response to treatment with a gluten-free diet

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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 that occurs in genetically susceptible individuals following ingestion of wheat, rye, or barley proteins.(1) The inflammation in celiac disease occurs primarily in the mucosa of the small intestine, which leads to villous atrophy.(1) Common clinical manifestations related to gastrointestinal inflammation include abdominal pain, malabsorption, diarrhea, and/or constipation.(2) 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.(3) 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.(1,2) The disease is also associated with other clinical disorders including thyroiditis, type I diabetes mellitus, Down syndrome, and IgA deficiency.(1,3)

 

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.(3)

 

A definitive diagnosis of celiac disease requires a jejunal biopsy demonstrating villous atrophy.(1-3) Given the invasive nature and cost of the biopsy, serologic tests may be used to identify individuals with a high probability of having celiac disease. Because no single laboratory test can be relied upon completely to establish a diagnosis of celiac disease, those individuals with positive laboratory results should be referred for small intestinal biopsy, thereby decreasing the number of unnecessary invasive procedures. Celiac disease is associated with a variety of autoantibodies, including endomysial, tissue transglutaminase (tTG), and deamidated gliadin antibodies.(4) 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.(2) The most sensitive and specific serologic tests are tTG and deamidated gliadin antibodies.

 

Testing for IgA and IgG antibodies to unmodified gliadin proteins is no longer recommended because of the low sensitivity and specificity of these tests for celiac disease; however, recent studies have identified specific B-cell epitopes on the gliadin molecule that, when deamidated by the enzyme tissue transglutaminase, have increased sensitivity and specificity for celiac disease.(5,6) The tests for deamidated gliadin antibodies, IgA and IgG, replace the older gliadin antibody tests, which have been discontinued at Mayo Clinic. The sensitivity and specificity of test DGLDN / Gliadin (Deamidated) Antibodies Evaluation, IgG and IgA, Serum for untreated, biopsy-proven celiac disease were comparable to TSTGP / Tissue Transglutaminase (tTG) Antibodies, IgA and IgG Profile, Serum in a recent study conducted at Mayo Clinic.(5)

 

The treatment for celiac disease is maintenance of a gluten-free diet.(1-3) 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. For evaluation purposes, all serologic tests ordered for the diagnosis of celiac disease should be performed while the patient is on a gluten-containing diet. Once a patient has initiated the gluten-free diet, serologic testing may be repeated to assess the response to treatment. In some patients, it may take up to 1 year for antibody titers to normalize. Persistently elevated results suggest poor adherence to the gluten-free diet or the possibility of refractory celiac disease.(1)

 

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.

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.

Negative: <20.0 U

Weak positive: 20.0-30.0 U

Positive: >30.0 U

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Positive test results for deamidated gliadin antibodies, IgA or IgG, are consistent with the diagnosis of celiac disease.

 

Negative results indicate a decreased likelihood of celiac disease.

 

Decreased levels of deamidated gliadin antibodies, IgA or IgG, following treatment with a gluten-free diet are consistent with adherence to the diet. Persistence of high levels of antibodies following dietary treatment suggest poor adherence to the diet or the presence of refractory disease.

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

Measurements of deamidated gliadin antibodies should not be relied upon exclusively to establish or rule out the diagnosis of celiac disease.

 

This test should not be ordered as a replacement for TSTGP / Tissue Transglutaminase (Ttg) Antibodies, IgA and IgG Profile, Serum.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Green PH, Cellier C: Celiac disease. New Eng J Med 2007;357:1731-1743

2. Green PH, Jabri B: Celiac disease. Annu Rev Med 2006;57:207-221

3. Harrison MS, Wehbi M, Obideen K: Celiac disease: More common than you think. Cleve Clinic J Med 2007;74:209-215

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

5. Rashtak S, Ettore MW, Homburger HA, Murray JA: Comparative usefulness of deamidated gliadin antibodies in the diagnosis of celiac disease. Clin Gastroenterol Hepatol 2008 Apr;6(4):426-432

6. Sugai E, Vazquez H, Nachman F, et al: Accuracy of testing for antibodies to synthetic gliadin-related peptides in celiac disease. Clin Gastroenterol Hepatol 2006;4:1112-1117

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

IgG antibodies to deamidated gliadin peptides are detected by enzyme-linked immunosorbent assay by binding to purified peptides adsorbed to the wells of a microtiter plate. Peptides are bound to the wells under conditions that preserve the antigens in their native states. Prediluted controls and diluted patient sera are added to separate wells allowing antibodies to bind to the deamidated gliadin peptides. Unbound sample constituents are washed away and horseradish peroxidase-labeled antihuman IgG antibody conjugate is added to each well. After a second incubation, unbound enzyme-labeled conjugate is washed away and bound conjugate is detected by adding tetramethylbenzidine chromogenic substrate. After a final incubation, colored product is measured spectrophotometrically and the absorbance compared to the low positive calibrator. The intensity of color is directly proportional to the level of IgG antibodies to deamidated gliadin peptides expressed in arbitrary units.(Instruction manual: QUANTA Lite Gliadin IgG II rev. 3, 4/2017. INOVA Diagnostics, Inc. San Diego, CA, 92131)

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.

2 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 has been cleared, approved, or is exempt by the US 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 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.

86258

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