Ordering Recommendation

Intended for pretransplant allele matching. Do not use for specific disease screening or diagnosis (eg, celiac disease, rheumatologic diseases).

Mnemonic
HLACLASSI
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-A, -B, and -C allelic polymorphisms on specimens for transplant candidates and their donors.
Methodology:
PCR followed by next generation sequencing of HLA-A, -B and -C 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 (A, B, or C)* 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

81379

Components
Component Test Code* Component Chart Name LOINC
3002319 HLA Class I-Locus A*, Allele 1
3002320 HLA Class I-Locus A*, Allele 2
3002321 HLA Class I-Locus B*, Allele 1
3002322 HLA Class I-Locus B*, Allele 2
3002323 HLA Class I-Locus C*, Allele 1
3002324 HLA Class I-Locus C*, Allele 2
3002325 HLA Class I Panel, Interpretation
3002326 EER HLA Class I Panel, Interpretation
3002593 Bw, Allele 1
3002594 Bw, Allele 2
* 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-A
  • HLA-B
  • HLA-C
  • Human leukocyte antigen
HLA Class I Panel (ABC) by Next Generation Sequencing