GTR Test Accession:
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GTR000529084.2
Last updated in GTR: 2021-11-11
View version history
GTR000529084.2, last updated: 2021-11-11
GTR000529084.1, last updated: 2016-12-16
Last annual review date for the lab: 2021-11-11
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At a Glance
Test purpose:
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Diagnosis;
Predictive;
Prognostic; ...
Conditions (15):
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Chromosomal gains, losses, deletions, translocations, and markers
Methods (1):
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Cytogenetics - Karyotyping: G-banding
Target population: Help
Patients with suspected Chromosomal abnormalities
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Specimen Source:
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- Amniocytes
- Amniotic fluid
- Chorionic villi
- Cord blood
- Fetal blood
- Fibroblasts
- Peripheral (whole) blood
- Product of conception (POC)
- Skin
Who can order: Help
- Genetic Counselor
- Health Care Provider
- Licensed Physician
- Physician Assistant
Test Order Code:
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FDCYTO1
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.
How to Order:
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Please contact nidaan@cdfd.org.in or 040-24749338 for any queries regarding sending samples and report enquiries.
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:
Lab contact for this test,
Test strategy
Conditions
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Total conditions: 15
Condition/Phenotype | Identifier |
---|
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 *
Karyotyping
G-banding
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis;
Predictive;
Prognostic;
Risk Assessment;
Screening
Target population:
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Patients with suspected Chromosomal abnormalities
Recommended fields not provided:
Clinical validity,
Clinical utility,
What is the protocol for interpreting a variation as a VUS?,
Are family members with defined clinical status recruited to assess significance of VUS without charge?,
Will the lab re-contact the ordering physician if variant interpretation changes?,
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
Interpretation performed in-house
Report generated in-house
Specimen preparation performed in-house
Wet lab work performed in-house
Entire test performed in-house
Interpretation performed in-house
Report generated in-house
Specimen preparation performed in-house
Wet lab work performed in-house
Analytical Validity:
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This test is evaluated for analytical validity using an established validation process utilizing abnormal and normal specimens as per CAP, ACMG, and CLIA guidelines. For standard postnatal constitutional karyotype analysis 20 cells are counted, 5 cells analyzed, and at least 2 cells are karyotyped. In cases where mosaicism is suspected, …
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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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Category:
Not Applicable
Additional Information
Reviews:
Clinical 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.