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BCR/ABL, p210, MRNA Detection Monitoring
Clinical Genetic Test
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offered by
Sanford Medical Genetics Laboratory
View lab's test page
LinkOut
GTR Test Accession: Help GTR000613426.2
CAP
INHERITED DISEASECANCERHEMATOLOGY ... View more
Last updated in GTR: 2024-10-31
View version history
Last annual review date for the lab: 2024-10-24 LinkOut
At a Glance
Test purpose: Help
Monitoring
Conditions (2): Help
Acute lymphoid leukemia; Chronic myelogenous leukemia, BCR-ABL1 positive
Genes (2): Help
ABL1 (9q34.12); BCR (22q11.23)
Methods (1): Help
Molecular Genetics - Targeted variant analysis: RT-ddPCR
Target population: Help
Individuals with BCR-ABL1 p210 variant positive chronic myeloid leukemia or …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Sanford Medical Genetics Laboratory
View lab's test page
Test short name: Help
BCR/ABL
Manufacturer's name: Help
QXDx BCR-ABL %IS Kit from Bio-Rad
Specimen Source: Help
  • Bone marrow
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
Test Order Code: Help
LBOR0011
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
Call Sanford Client support at (605) 328-5493
Order URL
Test service: Help
Monitoring
Test development: Help
Modified FDA (has FDA-reviewed entry, but with lab modifications/field changes)
Informed consent required: Help
Based on applicable state law
Test strategy: Help
BCR::ABL1, p210 fusion transcripts are quantified for monitoring of patients with BCR::ABL1 positive leukemia
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Lab contact for this test
Conditions Help
Total conditions: 2
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 2
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-ddPCR
* Instrument: Not provided
Clinical Information
Test purpose: Help
Monitoring
Target population: Help
Individuals with BCR-ABL1 p210 variant positive chronic myeloid leukemia or acute myeloid leukemia.
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
Digital droplet PCR to quantify BCR::ABL1 copies. Reported as a percentage of the number of ABL copes and adjusted to match the international scale (IS) to report the %IS. The %IS is also converted into a molecular response (MR) which is the log reduction of the current %IS from 100% … View more
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Limit of detection: MR4.7 (95% confidence). Sensitivity: 97.30%. Specificity: 89.47%.
Assay limitations: Help
This assay will not detect BCR::ABL e1a2 (p190), e19a2 (p230), or other rare transcripts. It is intended for monitoring patients with a BCR::ABL1 p210 positive hematologic neoplasm. The results should be interpreted in combination with all other clinical laboratory findings.
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
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.