HLA Class II Molecular Typing Disease Association
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Determining HLA Class II compatibility on specimens from bone marrow and solid organ transplant candidates and their donors
Polymerase Chain Reaction (PCR)/Sequence-Specific Oligonucleotide Probes (SSO)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HLA ClassII Mol Typing DiseaseAssoc
HLA Class II Molecular Phenotype
Specimen Type Describes the specimen type needed for testing
Whole Blood ACD-B
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube: Yellow top (ACD solution B)
Specimen Volume: 6 mL
Collection Instructions: Do not transfer blood to other containers.
Additional Information: Specimen acceptability is based on extracted DNA concentration and not sample age.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Whole Blood ACD-B||Refrigerated (preferred)|
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 that play a key role in transplantation.
Sequence-specific oligonucleotides are designed to provide low-to-medium resolution for HLA Class II (DR and DQ) typing. Low-to-medium resolution defines the typing at the antigen level. This is in contrast to high-resolution typing, which defines typing at the allele (molecular) level and is used primarily for typing donor-recipient pairs for unrelated bone marrow transplantation.
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.
Interpretation depends on the rationale for ordering the test. Assessments of acceptable donor/recipient matches are made on a case-by-case basis.
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 Provides recommendations for further in-depth reading of a clinical nature
1. Terasaki PI, Bernoco F, Park MS, et al: Microdroplet testing for HLA-A, B, C and D antigens. Am J Clin Path 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
Method Description Describes how the test is performed and provides a method-specific reference
The reverse sequence-specific oligonucleotide (SSO) DNA typing method consists of using PCR to amplify target DNA with group specific primers. The PCR product is denatured and allowed to rehybridize to complementary DNA probes bound to fluorescently coded microspheres. The mixture is labeled with a fluorescent dye that is able to detect biotinylated protein and nucleic acids. A flow analyzer detects the fluorescent emission on each probe and the reaction pattern is analyzed and interpreted. The assignment of the human leukocyte antigen (HLA) typing is based on the reaction pattern compared to patterns associated with published HLA gene sequences. This procedure produces a class I/II HLA low-to-medium resolution typing for use in transplant diagnostics and disease association.(Package insert: LABType SSO Typing Test, Canoga Park, CA: One Lamda, Inc.; Rev 19)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 7:30 a.m.-5 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Whole Blood 7 days; Extracted DNA 2 months
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
81375-HLA Class II typing, low resolution (eg, antigen equivalents); HLA-DRB1/3/4/5 and -DQB1
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|DR||DR Locus Serology||21341-3|
|DR1||DRB1 Locus Molecular||21341-3|
|DRW||DRw Locus Serology||In Process|
|DRB3M||DRB3 Locus Molecular||59022-4|
|DRB4M||DRB4 Locus Molecular||59021-6|
|DRB5M||DRB5 Locus Molecular||59020-8|
|DQ||DQ Locus Serology||34143-8|
|DQ2||DQA1 Locus Molecular||44728-4|
|DQ1||DQB1 Locus Molecular||13305-8|
|DP2||DPA1 Locus Molecular||59018-2|
|DP3||DPB1 Locus Molecular||59017-4|