Test Catalog

Test Id : 1DIS

Human Leukocyte Antigens (HLA) A-B-C Disease Association Typing Low Resolution, Blood

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

Determining class I human leukocyte antigens on specimens for those patients who have become refractory to platelet transfusions and identify potential disease association

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-A-B-C DisAssoc Typing LowRes,B

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

1DIS

Specimen Type
Describes the specimen type validated for testing

Whole Blood ACD

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: Yellow top (ACD solution 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.

Forms

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

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

Determining class I human leukocyte antigens on specimens for those patients who have become refractory to platelet transfusions and identify potential disease association

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Human leukocyte antigens (HLA) are regulators of the immune response. HLA class I typing is used to identify HLA-matched platelets for alloimmunized refractory patients and identify presence of HLA antigens associated with a number of diseases or as drug hypersensitivity markers Class I HLA antigens include A, B, and C loci. This assay is designed to provide low-to-medium resolution for HLA class I typing (A, B, C). Low-to-medium resolution defines the typing at the antigen level (first field). This is in contrast to high-resolution typing, which defines typing at the allele (molecular) level (second field or higher).

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 K: Microdroplet testing for HLA-A, -B, -C, and -D antigens. Am J Clin Pathol. 1978 Feb;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 Jul:46(7):996-998

3. Kennedy AE, Ozbek U, Dorak MT: What has GWAS done for HLA and disease associations? Int J Immunogenet. 2017 Oct;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 Jan;89(1):3-13. doi: 10.1111/tan.12947

5. Howell WM: HLA and disease: guilt by association. Int J Immunogenet. 2014 Feb;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 Jul;81(7):354-360

Method Description
Describes how the test is performed and provides a method-specific reference

Next-generation sequencing (NGS) is used to type for Class I alleles (A, B, and C) 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 through Friday

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.

5 to 9 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 Regional Manager. 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. This test 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.

81372

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
1DIS HLA-A-B-C DisAssoc Typing LowRes,B 96629-1
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
LRTMB Test Method 85069-3
LRTM1 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