Test Catalog

Test Id : DIS

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Human Leukocyte Antigens (HLA) Class I and II Disease Association Typing, Low Resolution, Blood

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identifying class I and II human leukocyte antigens (HLA) for potential disease associations or markers for drug hypersensitivity

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
1DIS HLA-A-B-C DisAssoc Typing LowRes,B Yes Yes
2DIS HLA-DR-DQ DisAssoc Typing LowRes,B Yes Yes

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.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HLA CI-CII DisAssoc Typing LowRes,B

Aliases
Lists additional common names for a test, as an aid in searching

Disease Association Typing

HLA Adverse Drug Reaction

Next Gen Sequencing Test

Specimen Type
Describes the specimen type validated for testing

Whole Blood ACD

Ordering Guidance

This test should be ordered if both human leukocyte antigen (HLA) Class I and Class II results are wanted for disease association.

 

If only needing patient's HLA Class I typing for disease association, order 1DIS / Human Leukocyte Antigens (HLA)-A-B-C Disease Association Typing Low Resolution, Blood.

 

If only needing patient's HLA Class II typing for disease association, order 2DIS / Human Leukocyte Antigens (HLA)-DR-DQ Disease Association Typing Low Resolution, Blood.

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.

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

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

Identifying class I and II human leukocyte antigens (HLA) for 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 antigens (HLA) class I and II genes (A, B, C, DRB1, DRB3/4/5, DQB1, DQA1, DPB1, DPA1) are a part of the major histocompatibility gene complex that encodes for proteins involved in immune recognition and are regulators of the immune response.

 

This assay is designed to provide low-to-medium resolution 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, 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 from 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 I alleles (A, B, and C) and 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

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, Thursday

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.

7 to 17 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 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 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.

81370

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
DIS HLA CI-CII DisAssoc Typing LowRes,B 98005-2
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.
1DA02 ABC DisAssoc Comment 96625-9
1DA03 A - 1 Equivalent 13298-5
1DA04 A - 2 Equivalent 13298-5
1DA05 A - 1 Molecular 78014-8
1DA06 A - 2 Molecular 78014-8
1DA07 B - 1 Equivalent 13299-3
1DA08 B - 2 Equivalent 13299-3
1DA09 B - 1 Molecular 78015-5
1DA10 B - 2 Molecular 78015-5
1DA11 Bw - 1 Equivalent 96633-3
1DA12 Bw - 2 Equivalent 96633-3
1DA13 C - 1 Equivalent 13302-5
1DA14 C - 2 Equivalent 13302-5
1DA15 C - 1 Molecular 96636-6
1DA16 C - 2 Molecular 96636-6
LRTM1 Test Method 85069-3
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

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

Test Update Resources

Change Type Effective Date
New Test 2023-09-20