Test Catalog

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) antigens to identify potential disease association and as markers for drug hypersensitivity

Method Name
A short description of the method used to perform the test

Polymerase Chain Reaction (PCR)/Sequence-Specific Oligonucleotide Probes (SSO)

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

HLA-DR-DQ DisAssoc Typing LowRes,B

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 B)

Specimen Volume: 6 mL

Collection Instructions: Send in original tube. Do not transfer blood to other containers.

Additional Information: Specimen acceptability is based on extracted DNA concentration and not sample age.

Forms

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

3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

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) antigens to identify potential disease association and as 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 is in contrast to 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, et al: Microdroplet testing for HLA-A, B, C and D antigens. Am J Clin Pathol. 1978 Feb;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 Jul;46(7):996-998

3. Kennedy AE, Ozbek U, Dorak MT: What has GWAS done for HLA and disease associations? Int J Immunogenet. 2017 Oct;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 Jan;89(1):3-13 doi: 10.1111/tan.12947

5. Howell WM: HLA and disease: guilt by assocation. Int J Immunogenet. 2014 Feb;41(1):1-12 doi: 10.1111/iji.12088

6. Profaizer T, Pole A, Monds C, et al. 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

The reverse sequence-specific oligonucleotide (SSO) DNA typing method consists of using polymerase chain reaction (PCR) to amplify target DNA with group specific primers. The PCR product is denatured and allowed to rehybridize to complementary DNA probes bound to fluorescently coded microspheres. The mixture is labeled with a fluorescent dye that is able to detect biotinylated protein and nucleic acids. A flow analyzer detects the fluorescent emission on each probe and the reaction pattern is analyzed and interpreted. The assignment of the human leukocyte antigen (HLA) typing is based on the reaction pattern compared to patterns associated with published HLA gene sequences.(Package insert: LABType SSO Typing Test. One Lamda; Rev 30. 02/2018)

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.

5 to 9 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.

81375 + 81376 (as appropriate)

 

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