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Test Code 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

Determining class II human leukocyte antigens (HLA) to identify potential disease associations or markers for drug hypersensitivity

Method Name

Polymerase Chain Reaction (PCR)/Next-Generation Sequencing (NGS)

Reporting Name

HLA-DR-DQ DisAssoc Typing LowRes,B

Specimen Type

Whole Blood ACD

Specimen 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 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

Not applicable

Interpretation

Interpretation depends on the rationale for ordering the test.

Cautions

No significant cautionary statements.

Method Description

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)

Day(s) Performed

Monday, Thursday

Report Available

7 to 17 days

Performing 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

81375

81376 x3

LOINC Code Information

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
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