Test ID: CELI
Celiac-Associated HLA-DQ Alpha 1 and DQ Beta 1 Medium-High Resolution DNA Typing, Blood
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
Assessing risk of 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
Polymerase Chain Reaction (PCR)/Sequence-Specific Oligonucleotide Probe (SSO)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
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
Celiac HLA
DQ2
DQ8
HLAD Q2
HLAD Q8
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: Yellow top (ACD solution B)
Specimen Volume: 6 mL
Collection Instructions: Do not transfer blood to other containers.
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 | NA |
| Lipemia | NA |
| Icterus | NA |
| 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 Type | Temperature | Time |
|---|---|---|
| Whole Blood ACD-B | Refrigerated (preferred) | |
| Ambient | ||
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Celiac disease (gluten-sensitive enteropathy) is mediated by T lymphocytes in patients with genetic susceptibility. This genetic association is with certain HLA genes in the class II region (DQ alpha 1, DQ beta 1).
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 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.
An interpretive report will be provided.
Interpretation Provides information to assist in interpretation of the test results
Most (90%-95%) patients with celiac disease have the DQ2 allele (encoded by DQA1*05 and DQB1*02), while the remainder have DQ8 (encoded by DQA1*03:01 and DQB1*03:02). Rare exceptions to these associations have been occasionally seen. In 1 study of celiac disease, only 0.7% of patients with celiac disease lacked the HLA alleles mentioned above.
It is important to realize that these genes also are present in about 20% of people without celiac disease. Therefore, the mere presence of these genes does not prove the presence of celiac disease or that genetic susceptibility to celiac disease is present.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
No significant cautionary statements
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Polvi A, Arranz E, Fernandez-Arequero M, et al: HLA-DQ2-negative celiac disease in Finland and Spain. Hum Immunol 1998 Mar;59(3):169-175
Method Description Describes how the test is performed and provides a method-specific reference
LABType applies Luminex technology to the reverse SSO DNA typing method. First, target DNA is PCR-amplified using a group-specific primer. The PCR product is biotinylated, which allows it to be detected using R-Phycoerythrin-conjugated streptavidin. The PCR product is denatured and allowed to rehybridize to complementary DNA probes conjugated to fluorescently coded microspheres. A flow analyzer, identifies the fluorescent intensity of phycoerythrin on each microsphere. The HLA Class II allele or allele groups of the sample is determined by the positive and negative bead ID's using a computer software program. The assignment of the HLA typing is based on the reaction pattern compared to patterns associated with published HLA gene sequences. (Package insert: One Lambda, LABType SSO Typing)
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 Friday; 7:30 a.m.-5:00 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.
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.
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.
81376 x 2-HLA Class II typing, low resolution (eg, antigen equivalents); one locus (eg, HLA-DRB1/3/4/5, -DQB1, -DQA1, -DPB1, or -DPA1), each
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 |
|---|---|---|
| DQA | DQ alpha 1 | 44728-4 |
| DQB | DQ beta 1 | 43291-4 |
| CELIG | Celiac gene pairs present? | In Process |
| CELIC | Interpretation | In Process |
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