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HLA High Resolution Panel by NGS
Clinical Genetic Test
Help
offered by
Versiti Diagnostic Laboratories
View lab's test page
LinkOut
GTR Test Accession: Help GTR000570025.2
NYS CLEP
HEMATOLOGYCANCERIMMUNOLOGY ... View more
Last updated in GTR: 2022-10-25
View version history
Last annual review date for the lab: 2023-06-08 Past due LinkOut
At a Glance
Test purpose: Help
Predictive; Therapeutic management
Conditions (4): Help
Lymphoma; Acute myeloid leukemia; Chronic myelogenous leukemia, BCR-ABL1 positive more...
Genes (11): Help
HLA-A (6p22.1); HLA-B (6p21.33); HLA-C (6p21.33); HLA-DPA1 (6p21.32); HLA-DPB1 (6p21.32) more...
Methods (1): Help
Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Versiti Diagnostic Laboratories
View lab's website
View lab's test page
Specimen Source: Help
  • Amniocytes
  • Amniotic fluid
  • Bone marrow
  • Buccal swab
  • Cell culture
  • Cord blood
  • Fetal blood
  • Isolated DNA
  • Peripheral (whole) blood
  • White blood cell prep
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
Test Order Code: Help
2300
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Jennifer Schiller, PhD, Lab Director
JJSchiller@Versiti.org
(414) 937-6053
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
Order URL
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test strategy
Conditions Help
Total conditions: 4
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 11
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Predictive; Therapeutic management
Recommended fields not provided:
Clinical validity, Clinical utility, Target population, What is the protocol for interpreting a variation as a VUS?, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Comments: Help
This test has been assigned a DEX Z-Code, please see app.dexzcode.com
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The informative class I and II HLA exons and introns of an individual sample are amplified using the polymerase chain reaction (PCR) with locus-specific primers. The nucleotide sequences for each HLA locus are determined using a Next Generation Sequencing platform where the PCR products for each sample are fragmented and … View more
Assay limitations: Help
Some rare allele combinations and alleles whose sequences differ outside the included HLA regions may not be completely resolved by this technique.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
ASHI
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, Citations for Analytical validity, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 53315
Status: Approved
Additional Information

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.