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Red Cell Genotyping Panel
Clinical Genetic Test
Help
offered by
Versiti Diagnostic Laboratories
View lab's test page
LinkOut
GTR Test Accession: Help GTR000559550.2
NYS CLEP
CAP
INHERITED DISEASEHEMATOLOGY
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 (1): Help
Hb SS disease
Genes (14): Help
ACHE (7q22.1), ACKR1 (1q23.2), AQP1 (7p14.3), ART4 (12p12.3), BCAM (19q13.32), ...
Methods (1): Help
Molecular Genetics - Targeted variant analysis: RT-qPCR
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for management
Ordering Information
Offered by: Help
Versiti Diagnostic Laboratories
View lab's website
View lab's test page
Specimen Source: Help
  • Bone marrow
  • Buccal swab
  • Buffy coat
  • Cell culture
  • Cord blood
  • Fetal blood
  • Isolated DNA
  • Peripheral (whole) blood
  • White blood cell prep
  • View specimen requirements
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
Test Order Code: Help
3530
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

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 (no manufacturer test name)
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:
Lab contact for this test, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 14
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Targeted variant analysis
RT-qPCR
WaferGen Bio-systems
Clinical Information
Test purpose: Help
Predictive; Therapeutic management
Clinical utility: Help
Guidance for management
View citations (1)
  • Wilkinson K, Harris S, Gaur P, Haile A, Armour R, Teramura G, Delaney M. Molecular blood typing augments serologic testing and allows for enhanced matching of red blood cells for transfusion in patients with sickle cell disease. Transfusion. 2012;52(2):381-8. doi:10.1111/j.1537-2995.2011.03288.x. Epub 2011 Aug 09. PMID: 21827505.

Recommended fields not provided:
Clinical validity, 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
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical sensitivity is >97%. Other mutations in the targeted genes are not detected by this assay. Rare polymorphisms within primer or probe regions may interfere with detection of these gene variants.
Assay limitations: Help
Mutations outside of the targeted region will not be detected. Novel mutations leading to altered or partial antigen expression and null phenotypes may not be detected by this testing method. Results from stem cell transplant patients may not match genotype obtained from other tissues.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
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
Not provided
NYS CLEP Approval: Help
Number: 31069
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.