GTR Test Accession:
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GTR000591526.1
NYS CLEP
Last updated in GTR: 2020-08-24
View version history
GTR000591526.1, last updated: 2020-08-24
Last annual review date for the lab: 2023-11-27
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At a Glance
Test purpose:
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Prognostic;
Diagnosis;
Therapeutic management
Conditions (2):
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Glioma; Oligodendroglioma
Analytes (1):
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1p and 19q deletion, IDH1 R132H mutation by IHC
Genes (1):
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IDH1 (2q34)
Methods (2):
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Biochemical Genetics - Immunohistochemistry: Immunohistochemistry; ...
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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Who can order: Help
- Health Care Provider
Test Order Code:
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3002135
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.
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,
Test strategy,
Test development
Conditions
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Total conditions: 2
Condition/Phenotype | Identifier |
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Test Targets
Analytes
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Total analytes: 1
Analyte | Associated Condition |
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Genes
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Total genes: 1
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 2
Method Category
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Test method
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Instrument *
Immunohistochemistry
Immunohistochemistry
Sequence analysis of select exons
Bi-directional Sanger Sequence Analysis
* Instrument: Not provided
Clinical Information
Test purpose:
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Prognostic;
Diagnosis;
Therapeutic management
Recommended fields not provided:
Clinical validity,
Clinical utility,
Target population,
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
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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For IDH1 and IDH2 sequencing, the limit of detection is 20 percent mutant allele.
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
NYS CLEP Approval:
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Number:
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.