Home
HelpTest Code DIS Human Leukocyte Antigens (HLA) Class I and II Disease Association Typing, Low Resolution, Blood
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
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.
Useful For
Identifying class I and II human leukocyte antigens (HLA) for potential disease associations or markers for drug hypersensitivity
Profile Information
| 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
Polymerase Chain Reaction (PCR)/Next-Generation Sequencing (NGS)
Reporting Name
HLA CI-CII DisAssoc Typing LowRes,BSpecimen Type
Whole Blood ACDSpecimen Minimum Volume
3 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Whole Blood ACD | Ambient (preferred) | ||
| Refrigerated | |||
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Clinical Information
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
Not applicable
Interpretation
Interpretation depends on the rationale for ordering the test.
Cautions
No significant cautionary statements
Clinical Reference
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
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)
Day(s) Performed
Monday, Thursday
Report Available
7 to 17 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
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
81370
81376 x3
LOINC Code Information
| 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 |
|---|---|---|
| 1DA02 | ABC DisAssoc Comment | 96625-9 |
| 2DA02 | DRDQ DisAssoc Comment | 96625-9 |
| 2DA03 | DRB1 - 1 Equivalent | 57298-2 |
| 1DA03 | A - 1 Equivalent | 13298-5 |
| 1DA04 | A - 2 Equivalent | 13298-5 |
| 2DA04 | DRB1 - 2 Equivalent | 57298-2 |
| 2DA05 | DRB1 - 1 Molecular | 96664-8 |
| 1DA05 | A - 1 Molecular | 78014-8 |
| 1DA06 | A - 2 Molecular | 78014-8 |
| 2DA06 | DRB1 - 2 Molecular | 96664-8 |
| 2DA07 | DRB345 - 1 Equivalent | 96673-9 |
| 1DA07 | B - 1 Equivalent | 13299-3 |
| 1DA08 | B - 2 Equivalent | 13299-3 |
| 2DA08 | DRB345 - 2 Equivalent | 96673-9 |
| 2DA09 | DRB345 - 1 Molecular | 96672-1 |
| 1DA09 | B - 1 Molecular | 78015-5 |
| 1DA10 | B - 2 Molecular | 78015-5 |
| 2DA10 | DRB345 - 2 Molecular | 96672-1 |
| 2DA11 | DQB1 - 1 Equivalent | 53938-7 |
| 1DA11 | Bw - 1 Equivalent | 96633-3 |
| 1DA12 | Bw - 2 Equivalent | 96633-3 |
| 2DA12 | DQB1 - 2 Equivalent | 53938-7 |
| 2DA13 | DQB1 - 1 Molecular | 78017-1 |
| 1DA13 | C - 1 Equivalent | 13302-5 |
| 1DA14 | C - 2 Equivalent | 13302-5 |
| 2DA14 | DQB1 - 2 Molecular | 78017-1 |
| 2DA15 | DQA1 - 1 Molecular | 96654-9 |
| 1DA15 | C - 1 Molecular | 96636-6 |
| 1DA16 | C - 2 Molecular | 96636-6 |
| 2DA16 | DQA1 - 2 Molecular | 96654-9 |
| 2DA17 | DPB1 - 1 Molecular | 96648-1 |
| LRTM1 | Test Method | 85069-3 |
| 2DA18 | DPB1 - 2 Molecular | 96648-1 |
| 2DA19 | DPA1 - 1 Molecular | 96643-2 |
| 2DA20 | DPA1 - 2 Molecular | 96643-2 |
| LRTM2 | Test Method | 85069-3 |