GTR Test Accession:
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GTR000571202.1
Registered in GTR:
2020-02-25
View version history
GTR000571202.1,
registered in GTR:
2020-02-25
Last annual review date for the lab: 2023-07-21
Past due
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At a Glance
Test purpose:
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Diagnosis
Conditions (1):
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Acute lymphoid leukemia
Order in cases of Philadelphia chromosome positive (Ph+) lymphoblastic leukemia to quantify the BCR-ABL1 p190 fusion form.
Methods (1):
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Molecular Genetics - Targeted variant analysis: Quantitative PCR (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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Test Order Code:
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8972
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:
How to Order,
Specimen source,
Lab contact for this test,
Contact policy,
Test strategy,
Test development
Conditions
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Total conditions: 1
| Condition/Phenotype | Identifier |
|---|
Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 1
| Chromosomal region/Mitochondrion | Associated condition |
|---|
Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Targeted variant analysis
Quantitative PCR (qPCR)
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis
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
Availability:
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Tests performed
Interpretation performed at an outside lab
Report generated at an outside lab
Specimen preparation performed in-house
Wet lab work performed at an outside lab
Test performance comments
Samples received will be tested by ARUP.
Interpretation performed at an outside lab
Report generated at an outside lab
Specimen preparation performed in-house
Wet lab work performed at an outside lab
Test performance comments
Samples received will be tested by ARUP.
Analytical Validity:
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This test has more than 99% analytical sensitivity for detecting substitution variants and small indels in the target region.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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No
No
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
PT Provider,
Description of PT method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Not provided
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.