GTR Test Accession:
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GTR000597448.1
Registered in GTR:
2022-04-27
View version history
GTR000597448.1,
registered in GTR:
2022-04-27
Last annual review date for the lab: 2024-11-03
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At a Glance
Methods (1):
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Molecular Genetics - Targeted variant analysis: SNP Detection
Target population: Help
Available for all ethnicity and populations
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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SGH005_V2
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: 31
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 10
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Targeted variant analysis
SNP Detection
* Instrument: Not provided
Clinical Information
Test purpose:
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Drug Response
Target population:
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Available for all ethnicity and populations
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
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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SPMED PGx-Standard has more than 95% sensitivity (limit of detection), 100% sensitivity for the cut off value, 100% accuracy, 100% precision for repeatability and reproducibility and no cross-reactivity and interference regarding specificity.
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
Clinical resources:
Molecular resources:
Consumer resources:
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.