Test ID: CDSP
Celiac Disease Serology Cascade
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Evaluating patients suspected of having celiac disease, including patients with compatible symptoms, patients with atypical symptoms, and individuals at increased risk (family history, previous diagnosis with associated disease, positivity for DQ2 and/or DQ8)
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| IGA | Immunoglobulin A (IgA), S | Yes | Yes |
| CDSP1 | Celiac Disease Interpretation | No | Yes |
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| EMA | Endomysial Abs, S (IgA) | Yes | No |
| DAGL | Gliadin(Deamidated) Ab, IgA, S | Yes | No |
| TTGG | Tissue Transglutaminase Ab, IgG, S | Yes | No |
| DGGL | Gliadin(Deamidated) Ab, IgG, S | Yes | No |
| TTGA | Tissue Transglutaminase Ab, IgA, S | Yes | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If IgA is age-specified normal, then tissue transglutaminase (tTG) IgA will be performed at an additional charge.
If tTG IgA is equivocal, then endomysial antibodies IgA and deamidated gliadin antibody IgA will be performed at an additional charge.
If IgA is > or =1.0 mg/dL but lower than age-specified normal, then tTG IgA, tTG IgG, deamidated gliadin IgA, and deamidated gliadin IgG will be performed at an additional charge.
If IgA is below detection (<1.0 mg/dL), then tTG IgG and deamidated gliadin IgG will be performed at an additional charge.
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
IGA/8157: Nephelometry
TTGA/82587, TTGG/83660, DAGL/89029, DGGL/89030: Enzyme-Linked Immunosorbent Assay (ELISA)
EMA/9360: Indirect Immunofluorescence Assay (IFA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Antiendomysial Antibody
Antimesothelial Antibody
Celiac Disease
Coeliac Disease
Dermatitis Herpetiformis
EA
EMA
Failure to Thrive
Gamma-Globulins, Quantitative
Gliadin Antibodies IgA
Gliadin Antibodies IgG
Gliadin IgA, Serum
Gliadin IgG, Serum
Gluten-sensitive Enteropathy
IgA (Immunoglobulin A)
Immunofluorescence Antibodies
Malabsorption
Soft-CDSP
Sprue
Tissue Transglutaminase (tTG)
Tissue Transglutaminase Ab IgA
Transglutaminase (tTG)
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.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 2 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.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | See individual test IDs |
| Lipemia | See individual test IDs |
| Icterus | See individual test IDs |
| Other | See individual test IDs |
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 Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (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.(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 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 with 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 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. In terms of serology, celiac disease is associated with a variety of autoantibodies, including endomysial (EMA), 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.
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 (see Celiac Disease Routine Treatment Monitoring Algorithm in Special Instructions). This is typically accompanied by an improvement in clinical symptoms
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/89201 Celiac Disease Comprehensive Cascade: complete testing including HLA DQ typing and serology
-CDSP/89199 Celiac Disease Serology Cascade: complete serology 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
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.
Immunoglobulin A
0-<5 months: 7-37 mg/dL
5-<9 months: 16-50 mg/dL
9-<15 months: 27-66 mg/dL
15-<24 months: 36-79 mg/dL
2-<4 years: 27-246 mg/dL
4-<7 years: 29-256 mg/dL
7-<10 years: 34-274 mg/dL
10-<13 years: 42-295 mg/dL
13-<16 years: 52-319 mg/dL
16-<18 years: 60-337 mg/dL
> or =18 years: 61-356 mg/dL
Interpretation Provides information to assist in interpretation of the test results
Immunoglobulin A (IgA):
Total IgA levels below the age-specific reference range suggest either a selective IgA deficiency or a more generalized immunodeficiency. For individuals with a low IgA level, additional clinical and laboratory evaluation is recommended. Some individuals may have a partial IgA deficiency in which the IgA levels are detectable but fall below the age-adjusted reference range. For these individuals, both IgA and IgG isotypes for tTG and deamidated gliadin antibodies are recommended for the evaluation of celiac disease; IgA-tTG, IgG-tTG, IgA-deamidated gliadin, and IgG-deamidated gliadin antibody assays are performed in this cascade. For individuals who have selective IgA deficiency or undetectable levels of IgA, only IgG-tTG and IgG-deamidated gliadin antibody assays are performed.
Tissue Transglutaminase (tTG) Ab, IgA/IgG:
Individuals positive for tTG antibodies of the IgA isotype likely have celiac disease and a small intestinal biopsy is recommended. For individuals with selective IgA deficiency, testing for tTG antibodies of the IgG isotype is performed. In these individuals, a positive IgG-tTG antibody result suggests a diagnosis of celiac disease. However, just as with the IgA-tTG antibody, a biopsy should be performed to confirm the diagnosis. Negative tTG IgA and/or IgG antibody serology does not exclude a diagnosis of celiac disease, as antibody levels decrease over time in patients who have been following a gluten-free diet.
Gliadin (Deamidated) Ab, IgA/IgG:
Positivity for deamidated gliadin antibodies of the IgA isotype is suggestive of celiac disease; small intestinal biopsy is recommended. For individuals with selective IgA deficiency, testing for deamidated gliadin antibodies of the IgG isotype is performed. In these individuals, a positive IgG-deamidated gliadin antibody result suggests a diagnosis of celiac disease. However, just as with the IgA-deamidated gliadin antibody, a biopsy should be performed to confirm the diagnosis. Negative deamidated gliadin IgA and/or IgG antibody serology does not exclude a diagnosis of celiac disease, as antibody levels decrease over time in patients who have been following a gluten-free diet.
Endomysial (EMA) Ab, IgA:
Positivity for endomysial (EMA) antibodies of the IgA isotype is suggestive of celiac disease, and small intestinal biopsy is recommended. For individuals with selective IgA deficiency, evaluation of EMA antibodies is not indicated. Negative EMA antibody serology does not exclude a diagnosis of celiac disease as antibody levels decrease over time in patients who have been following a gluten-free diet.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This cascade 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 for whom a small intestinal biopsy is recommended.
This cascade should not be used in patients who have previously been or are currently being treated with a gluten-free diet. For these individuals, CDGF/89200 Celiac Disease Comprehensive Cascade for Patients on a Gluten-Free Diet should be ordered.
This cascade should not be used in individual who are negative for DQ2 and DQ8, as a diagnosis of celiac disease is unlikely. For individuals who are positive for either DQ2 and/or DQ8, this test may be ordered to assess the levels of autoantibodies associated with celiac disease.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Green PHR, Cellier C: Medical progress: Celiac disease. N Engl J Med 2007;357:1731-1743
2. Green PHR, Jabri J: Celiac disease. Ann 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. Update on celiac disease: New standards and new tests. Mayo Communique (2008)
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.
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.
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.
82784-IgA
83516-Deamidated gliadin IgA (if appropriate)
83516-Deamidated gliadin IgG (if appropriate)
83516-tTG IgA (if appropriate)
83516-tTG IgG (if appropriate)
86256-Endomysial antibodies (if appropriate)
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 |
|---|---|---|
| IGA | Immunoglobulin A (IgA), S | 2458-8 |
| 28991 | Celiac Disease Interpretation | In Process |
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