Test Id : DAGL
Gliadin (Deamidated) Antibody, IgA, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Assessment of deaminated gliadin IgA antibodies for 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)
Monitoring response to a gluten-free diet in patients with celiac disease
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
The following algorithms are available:
-Celiac Disease Comprehensive Cascade Test Algorithm
-Celiac Disease Diagnostic Testing Algorithm
-Celiac Disease Gluten-Free Cascade Test Algorithm
-Celiac Disease Routine Treatment Monitoring Algorithm
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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Celiac Disease
Coeliac Disease
Gliadin Antibodies IgA
Gliadin IgA, Serum
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
The following algorithms are available:
-Celiac Disease Comprehensive Cascade Test Algorithm
-Celiac Disease Diagnostic Testing Algorithm
-Celiac Disease Gluten-Free Cascade Test Algorithm
-Celiac Disease Routine Treatment Monitoring Algorithm
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, Serum and Whole Blood: complete testing including HLA DQ
-CDSP / Celiac Disease Serology Cascade, Serum: complete serology testing excluding HLA DQ
-CDGF / Celiac Disease Gluten-Free Cascade, Serum and Whole Blood: for patients already adhering to a gluten-free diet
To order individual tests, see Celiac Disease Diagnostic Testing Algorithm.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Sarstedt Aliquot Tube 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
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 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. The minimum volume is sufficient for one attempt at testing.
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
Assessment of deaminated gliadin IgA antibodies for 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)
Monitoring response to a gluten-free diet in patients with celiac disease
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
The following algorithms are available:
-Celiac Disease Comprehensive Cascade Test Algorithm
-Celiac Disease Diagnostic Testing Algorithm
-Celiac Disease Gluten-Free Cascade Test Algorithm
-Celiac Disease Routine Treatment Monitoring Algorithm
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. Common clinical manifestations related to gastrointestinal inflammation include abdominal pain, malabsorption, diarrhea, and/or 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.
Individuals with family members who have celiac disease are at increased risk of developing the disease. Genetic susceptibility is related to specific human leukocyte antigen (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. For this reason, HLA-DQ2 and HLA-DQ8 are considered genetic risk factors for celiac disease and are required, but not sufficient, for the disease process to occur. HLA testing is not required for diagnosis in all cases, but can be useful in situations where histology and serology are discrepant, or for individuals who have started a gluten free diet before evaluation.(3)
A definitive diagnosis of celiac disease requires a duodenal biopsy demonstrating villous atrophy.(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, individuals with positive laboratory results may be referred for small intestinal biopsy, thereby decreasing the number of unnecessary invasive procedures (see Celiac Disease Diagnostic Testing Algorithm). In terms of serology, celiac disease is associated with a variety of autoantibodies, including endomysial antibody, 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. The most sensitive and specific serologic test is tTG IgA isotype, in individuals who produce sufficient total IgA. For individuals who are IgA deficient, testing for tTG and deamidated gliadin IgG antibodies is required.
A recent multi-cohort international study found that a tTG IgA titer of greater than or equal to 10 times the upper limit of normal (ULN) had a positive predictive value of 95% in an adult population.(5) In addition, several prospective studies have shown that a biopsy free approach to celiac disease diagnosis may be possible in children with a tTG titer greater than or equal to 10 times the ULN who meet certain criteria.(6-9) Given this evidence, the American College of Gastroenterology now suggests that a positive tTG IgA result greater than 10 times the upper limit of normal with a positive endomysial antibody in a separate blood sample may be sufficient for a diagnosis celiac disease in children.(3)
The treatment for celiac disease is maintenance of a gluten-free diet. In most patients who adhere to this diet, concentrations of associated autoantibodies decline, which is sometimes accompanied by reconstitution of the small intestinal villi. In most patients, an improvement in clinical symptoms is observed. 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.
See Celiac Disease Diagnostic Testing Algorithm 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.
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 IgA antibodies are consistent with a diagnosis of celiac disease.
Negative results for deamidated gliadin IgA antibodies indicate a decreased likelihood of celiac disease.
A decrease in the concentration of deamidated gliadin IgA antibodies may begin after initiation of a gluten-free diet and could indicate a response to 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 deamidated gliadin 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, a bowel biopsy should be performed regardless of serologic test results.
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.
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. Rubin JE, Crowe SE. Celiac disease. Ann Intern Med. 2020;172(1):ITC1-ITC16. doi:10.7326/AITC202001070
2. Lebwohl B, Rubio-Tapia A: Epidemiology, presentation, and diagnosis of celiac disease. Gastroenterology. 2021;160(1):63-75. doi:10.1053/j.gastro.2020.06.098
3. Rubio-Tapia A, Hill ID, Semrad C, et al. American College of Gastroenterology Guidelines Update: Diagnosis and Management of Celiac Disease [published correction appears in Am J Gastroenterol. 2024 Jul 1;119(7):1441. doi: 10.14309/ajg.0000000000002210.]. Am J Gastroenterol. 2023;118(1):59-76. doi:10.14309/ajg.0000000000002075
4. Penny HA, Raju SA, Sanders DS. Progress in the serology-based diagnosis and management of adult celiac disease. Exp Rev Gastroenterol Heptatol. 2020;14(3):147-154. doi:10.1080/17474124.2020.1725472
5. Penny HA, Raju SA, Lau MS, et.al. Accuracy of a no-biopsy approach for the diagnosis of coeliac disease across different adult cohorts. Gut. 2021;70(5):876-883. doi:10.1136/gutjnl-2020-320913
6. Ylonen V, Lindfors K, Repo M, et al. Non-Biopsy Serology-Based Diagnosis of Celiac Disease in Adults Is Accurate with Different Commercial Kits and Pre-Test Probabilities. Nutrients. 2020;12(9):2736. Published 2020 Sep 8. doi:10.3390/nu12092736
7. Werkstetter KJ, Korponay-Szabo IR, Popp A, et al. Accuracy in Diagnosis of Celiac Disease Without Biopsies in Clinical Practice. Gastroenterology. 2017;153(4):924-935. doi:10.1053/j.gastro.2017.06.002
8. Wolf J, Petroff D, Richter T, et al. Validation of Antibody-Based Strategies for Diagnosis of Pediatric Celiac Disease Without Biopsy. Gastroenterology. 2017;153(2):410-419.e17. doi:10.1053/j.gastro.2017.04.023
9. Ho SS, Keenan JI, Day AS. Role of serological tests in the diagnosis of coeliac disease in children in New Zealand. J Paediatr Child Health. 2020;56(12):1906-1911. doi:10.1111/jpc.15076
Method Description
Describes how the test is performed and provides a method-specific reference
IgA 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 IgA 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 IgA antibodies to deamidated gliadin peptides expressed in arbitrary units.(Instruction manual: QUANTA Lite Gliadin IgA II. INOVA Diagnostics, Inc; Rev 2, 10/2019)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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, Wednesday, 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.
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
Indicates the location of the laboratory that performs the test
Fees :
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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.
CPT codes are provided by the performing laboratory.
86258
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 |
|---|---|---|
| DAGL | Gliadin(Deamidated) Ab, IgA, S | 47393-4 |
| 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.
|
|---|---|---|
| DAGL | Gliadin(Deamidated) Ab, IgA, S | 47393-4 |