GTR Test Accession:
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GTR000568225.1
CAP
Last updated in GTR: 2019-06-27
View version history
GTR000568225.1, last updated: 2019-06-27
Last annual review date for the lab: 2024-04-29
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At a Glance
Test purpose:
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Diagnosis;
Monitoring
Conditions (1):
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Acute lymphoid leukemia
Analytes (1):
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BCR-ABL1 p190 (e1a2)
Methods (1):
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Molecular Genetics - RNA analysis: RT-qPCR
Target population: Help
Not provided
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Specimen Source:
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- Bone marrow
- Peripheral (whole) blood
- View specimen requirements
Who can order: Help
- Health Care Provider
Contact Policy:
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Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
Test service:
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Clinical Testing/Confirmation of Mutations Identified Previously
Test development:
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Test developed by laboratory (no manufacturer test name)
Informed consent required:
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Decline to answer
Pre-test genetic counseling required:
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Decline to answer
Post-test genetic counseling required:
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Decline to answer
Recommended fields not provided:
Test Order Code,
How to Order,
Lab contact for this test,
Test strategy
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
Analytes
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Total analytes: 1
Analyte | Associated Condition |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
RNA analysis
RT-qPCR
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis;
Monitoring
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:
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Detects the BCR-ABL1 minor (p190) fusion transcript
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Lower limit of detection 1:100,000
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
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,
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:
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Category:
FDA exercises enforcement discretion
Additional Information
Reviews:
Clinical resources:
Molecular resources:
Practice guidelines:
Consumer resources:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.