GTR Test Accession:
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GTR000600618.1
Registered in GTR:
2022-10-26
View version history
GTR000600618.1,
registered in GTR:
2022-10-26
Last annual review date for the lab: 2024-07-30
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At a Glance
Test purpose:
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Diagnosis;
Monitoring;
Therapeutic management
Conditions (1):
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Kidney Transplant Rejection
Human genome
Methods (1):
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Molecular Genetics - RNA analysis: Microarray
Target population: Help
Individuals with transplanted kidneys
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
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:
Test Order Code,
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 |
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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 *
RNA analysis
Microarray
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis;
Monitoring;
Therapeutic management
Target population:
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Individuals with transplanted kidneys
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
Test Comments:
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Expression data from 1,494 genes associated with allograft rejection, injury, and tissue specific markers
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Archetypes correlation for Global disturbance, Atrophy Fibrosis, Rejection, ABMR, NR, Early ABMR is between 0.90-0.98
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:
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.