Clinical Genetic Test
offered by
GTR Test Accession:
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GTR000569505.2
Last updated in GTR: 2024-02-22
View version history
GTR000569505.2, last updated: 2024-02-22
GTR000569505.1, last updated: 2023-09-29
Last annual review date for the lab: 2024-09-13
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At a Glance
Test purpose:
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Diagnosis
Conditions (1):
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Autosomal recessive nonsyndromic hearing loss 16
Genes (1):
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STRC (15q15.3)
Methods (3):
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Molecular Genetics - Deletion/duplication analysis: Digital microfluidic microspheres; 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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Genomic Diagnostic Laboratory, Division of Genomic Diagnostics
View lab's website
View lab's test page
View lab's website
View lab's test page
Test Order Code:
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STRCF
CPT codes:
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How to Order:
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Each specimen must be accompanied by a physician's test request. Informed consent is desirable. Proper billing information should also be provided on the test requisition form.
Order URL
Order URL
Test development:
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Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
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:
Specimen source,
Lab contact for this test,
Contact policy,
Test strategy
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
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: 3
Method Category
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Test method
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Instrument *
Deletion/duplication analysis
Digital microfluidic microspheres
Deletion/duplication analysis
Quantitative PCR (qPCR)
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* 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?,
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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Analytical sensitivity and specificity = ~99%
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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Category:
FDA exercises enforcement discretion
Additional Information
Clinical resources:
Molecular resources:
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.