Test Id : 2DIS
Human Leukocyte Antigens (HLA)-DR-DQ Disease Association Typing Low Resolution, Blood
Useful For
Suggests clinical disorders or settings where the test may be helpful
Determining class II human leukocyte antigens (HLA) to identify potential disease associations or markers for drug hypersensitivity
Method Name
A short description of the method used to perform the test
Polymerase Chain Reaction (PCR)/Next-Generation Sequencing (NGS)
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
2DIS
Specimen Type
Describes the specimen type validated for testing
Whole Blood ACD
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Container/Tube: Yellow top (ACD solution A or B)
Specimen Volume: 6 mL
Collection Instructions: Send whole blood in original tube. Do not aliquot.
Additional Information: Specimen acceptability is based on extracted DNA concentration and not sample age.
Forms
If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) 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.
3 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
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 |
|---|---|---|---|
| Whole Blood ACD | Ambient (preferred) | ||
| Refrigerated | |||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Determining class II human leukocyte antigens (HLA) to identify potential disease associations or markers for drug hypersensitivity
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Human leukocyte antigen (HLA) class II genes (HLA-DRB1, -DRB3/4/5, -DQA1, -DQB1, -DPA1, -DPB1) are a part of the major histocompatibility gene complex that encodes for proteins involved in immune recognition.
This assay is designed to provide low-to-medium resolution for HLA class II typing. Low-to-medium resolution defines the typing at first field (antigen or allele group level). This contrasts with high-resolution typing, which defines typing at second field or higher (allele level).
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.
Not applicable
Interpretation
Provides information to assist in interpretation of the test results
Interpretation depends on the rationale for ordering the test.
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
Recommendations for in-depth reading of a clinical nature
1. Terasaki PI, Bernoco D, Park MS, Ozturk G, Iwaki Y. Microdroplet testing for HLA-A, B, C and D antigens. The Phillip Levine Award Lecture. Am J Clin Pathol. 1978;69(2):103-120
2. Colinas RJ, Bellisario R, Pass KA. Multiplexed genotyping of beta-globin variants form PCR-amplified newborn blood spot DNA by hybridization with allele-specific oligodeoxynucleotides coupled to an array of fluorescent microspheres. Clin Chem. 2000;46(7):996-998
3. Kennedy AE, Ozbek U, Dorak MT. What has GWAS done for HLA and disease associations? Int J Immunogenet. 2017;44(5):195-211. doi:10.1111/iji.12332
4. Caillat-Zucman S. New insights into the understanding of MHC associations with immune-mediated disorders. HLA. 2017;89(1):3-13. doi:10.1111/tan.12947
5. Howell WM. HLA and disease: guilt by association. Int J Immunogenet. 2014;41(1):1-12. doi:10.1111/iji.12088
6. Profaizer T, Pole A, Monds C, Delgado JC, Lazar-Molnar E. Clinical utility of next generation sequencing based HLA typing for disease association and pharmacogenetic testing. Hum Immunol. 2020;81(7): 354-360
Method Description
Describes how the test is performed and provides a method-specific reference
Next-generation sequencing is used to type for Class II alleles (DRB1, DRB3/4/5, DQB1, DQA1, DPB1, and DPA1) from genomic DNA. This method uses strictly controlled polymerase chain reaction (PCR) conditions for DNA amplification. The PCR amplicons are processed and sequenced via the Illumina MiSeq instrument. The output files are analyzed in provided software, which compares the data against the IMGT/HLA database to assign the molecular typing.(Package inserts: Holotype HLA Kit. Omixon; v3.0.1, 08/16/2019; NGSgo HLA Kit. GenDx; v2, 02/2021)
For resolution of an allelic ambiguity or in select cases, the following additional methodologies may be utilized:
-Sequence-based typing (SBT) by Sanger sequencing(Package insert: SeCore Sequencing and GSSP Kits. One Lambda, Inc; Rev 3, 02/06/2021)
-SBT by sequence-specific primers (SSP)(Package insert: Olerup SSP HLA typing kits including Taq Polymerase. CareDx; Rev 04, 12/2020)
-Reverse sequence-specific oligonucleotides (SSO)(Package insert: LABType SSO Typing Test. One Lambda, Inc.; Rev 04, 11/11/2019)
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
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 :
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 account representative. 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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.
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.
81375
81376 x3
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 |
|---|---|---|
| 2DIS | HLA-DR-DQ DisAssoc Typing LowRes,B | 96640-8 |
| 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.
|
|---|---|---|
| 2DA02 | DRDQ DisAssoc Comment | 96625-9 |
| 2DA03 | DRB1 - 1 Equivalent | 57298-2 |
| 2DA04 | DRB1 - 2 Equivalent | 57298-2 |
| 2DA05 | DRB1 - 1 Molecular | 96664-8 |
| 2DA06 | DRB1 - 2 Molecular | 96664-8 |
| 2DA07 | DRB345 - 1 Equivalent | 96673-9 |
| 2DA08 | DRB345 - 2 Equivalent | 96673-9 |
| 2DA09 | DRB345 - 1 Molecular | 96672-1 |
| 2DA10 | DRB345 - 2 Molecular | 96672-1 |
| 2DA11 | DQB1 - 1 Equivalent | 53938-7 |
| 2DA12 | DQB1 - 2 Equivalent | 53938-7 |
| 2DA13 | DQB1 - 1 Molecular | 78017-1 |
| 2DA14 | DQB1 - 2 Molecular | 78017-1 |
| 2DA15 | DQA1 - 1 Molecular | 96654-9 |
| 2DA16 | DQA1 - 2 Molecular | 96654-9 |
| 2DA17 | DPB1 - 1 Molecular | 96648-1 |
| 2DA18 | DPB1 - 2 Molecular | 96648-1 |
| 2DA19 | DPA1 - 1 Molecular | 96643-2 |
| 2DA20 | DPA1 - 2 Molecular | 96643-2 |
| LRTM2 | Test Method | 85069-3 |