Ordering Recommendation

Not intended for HLA-related disease screening or diagnosis (eg, celiac disease, narcolepsy, rheumatologic diseases).

Mnemonic
HLACLASSII
Methodology

Polymerase Chain Reaction (PCR)/Massively Parallel Sequencing

Performed

Varies

Reported

8-15 days

New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Specimen Required
Patient Preparation
Collect

Lavender (K2 EDTA). Also acceptable: Yellow (ACD Solution A).

Specimen Preparation

Transfer 4 mL whole blood to an ARUP Standard Transport Tube. (Min: 1 mL).

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Specimens collected in Yellow (ACD Solution B). Clotted, grossly hemolyzed, or heparinized specimens.

Remarks
Stability

Ambient: 72 hours; Refrigerated: 1 week; Frozen: Unacceptable

Reference Interval

By report

Interpretive Data

Purpose: To identify HLA-DRB1, DQA1 and DQB1 allelic polymorphisms on specimens for transplant candidates and their donors.
Methodology:
PCR followed by next generation sequencing of HLA-DRB1, DQA1 and DQB1 loci.
Analytical Sensitivity & Specificity:
 >99 percent.
Limitations:
Rare diagnostic errors can occur due to primer site mutations.
Test Results:
Results are reported as HLA locus (DRB1, DQA1 or DQB1)* followed by the two-field (four digit) assigned allele.

Disclaimer Information:
HLA typing is performed by one or more of the following methodologies: next generation sequencing (NGS) and/or sequence specific probe hybridization (SSOP). The NMDP code provides possible rare alleles that cannot be ruled out. Additional unknown DNA polymorphisms could exist outside of the regions analyzed, the significance of which is not known.

This test was developed and its performance characteristics determined by the Histocompatibility& Immunogenetics laboratory at the University of Utah Health, and has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes; it should not be regarded as investigational or for research. The University of Utah Histocompatibility& Immunogenetics laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing. Performed at: Histocompatibility& Immunogenetics laboratory, University of Utah Health, 417 Wakara Way, Suite 3220, Salt Lake City, UT 84108.

Compliance Category

Not Applicable

Note
Hotline History
N/A
CPT Codes

81382 x3

Components
Component Test Code* Component Chart Name LOINC
3002327 HLA Class II-Locus DRB1*, Allele 1
3002328 HLA Class II-Locus DRB1*, Allele 2
3002545 HLA Class II-Locus DQA1*, Allele 1
3002546 HLA Class II-Locus DQA1*, Allele 2
3002547 HLA Class II-Locus DQB1*, Allele 1
3002548 HLA Class II-Locus DQB1*, Allele 2
3002549 HLA Class II Panel, Interpretation
3002550 EER HLA Class II Panel, Interpretation
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • HLA-DQB1
  • HLA-DRB1
  • Human leukocyte antigen
HLA Class II Panel (DRB1, DQA1 and DQB1) by Next Generation Sequencing