GTR Test Accession:
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GTR000594305.1
Registered in GTR:
2021-09-08
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GTR000594305.1,
registered in GTR:
2021-09-08
Last annual review date for the lab: 2023-09-15
Past due
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At a Glance
Test purpose:
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Diagnosis
Conditions (1):
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Male infertility
Analytes (1):
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Reactive oxygen species byproduct
Methods (1):
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Biochemical Genetics - Immunohistochemistry: Fluorometry
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 Order Code:
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4699
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: 1
Condition/Phenotype | Identifier |
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Test Targets
Analytes
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Total analytes: 1
Analyte | Associated Condition |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Immunohistochemistry
Fluorometry
* 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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The analysis is based on the determination of Reactive Oxygen Derivatives (ROS) by the intracellular fluorometric method applied to the sperm sample prepared from the given spermiogram sample. The decision is based on the ratio of ROS positive sperm cells to the total population and is limited to the population …
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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.