GTR Test Accession:
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GTR000528947.2
NYS CLEP
CAP
Last updated in GTR: 2015-12-11
View version history
GTR000528947.2, last updated: 2015-12-11
GTR000528947.1, last updated: 2015-12-09
Last annual review date for the lab: 2021-09-08
Past due
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At a Glance
Test purpose:
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Diagnosis;
Monitoring;
Prognostic
Conditions (3):
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Chronic myelogenous leukemia, BCR-ABL1 positive;
Acute myeloid leukemia;
Precursor B-cell acute lymphoblastic leukemia
t(9;22)(q34;q11)
Methods (1):
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Cytogenetics - FISH-interphase: Fluorescence in situ hybridization (FISH)
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 short name:
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CML FISH Panel
Specimen Source:
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- Bone marrow
- Cell culture
- Fresh tissue
- Frozen tissue
- Isolated DNA
- Paraffin block
- Peripheral (whole) blood
- White blood cell prep
- View specimen requirements
Who can order: Help
- Genetic Counselor
- Health Care Provider
Test Order Code:
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CML FISH Panel
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.
How to Order:
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Sample types: PB, BM, FFPE, Fresh Tissue
Use Requisition form
No deliveries accepted on Sundays
Order URL
Use Requisition form
No deliveries accepted on Sundays
Order URL
Test development:
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Test developed by laboratory (no manufacturer test name)
Informed consent required:
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No
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Lab contact for this test,
Test strategy
Conditions
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Total conditions: 3
Condition/Phenotype | Identifier |
---|
Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion | Associated condition |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument
FISH-interphase
Fluorescence in situ hybridization (FISH)
CytoVision
Clinical Information
Test purpose:
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Diagnosis;
Monitoring;
Prognostic
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 Procedure:
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Florescence in situ hybridization
Test Platform:
None/not applicable
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Assay Sensitivity & Specificity For probe sensitivity and specificity, peripheral blood specimens from five normal males (all karyotyped 46,XY) were hybridized with each probe or probe set. Two hundred metaphases (40 per male) total were analyzed for the specificity of probe hybridization. At least 5 images were taken for each …
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View citations (1)
- Dewald et al.
Assay limitations:
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Genetic changes other than those assayed here cannot be ruled out on the basis of this testing.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Intra-Laboratory
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Yes
Method used for proficiency testing: Help
Intra-Laboratory
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,
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
NYS CLEP Approval:
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Number:
8680
Status: Approved
Status: Approved
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
Consumer resources:
IMPORTANT NOTE:
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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.