GTR Test Accession:
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GTR000521879.5
Last updated in GTR:
2022-10-25
View version history
GTR000521879.5,
last updated:
2022-10-25
GTR000521879.4,
last updated:
2022-06-09
GTR000521879.3,
last updated:
2019-01-16
GTR000521879.2,
last updated:
2016-03-03
GTR000521879.1,
registered in GTR:
2015-03-18
Last annual review date for the lab: 2023-06-08
Past due
LinkOut
At a Glance
Test purpose:
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Monitoring;
Risk Assessment
Conditions (1):
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BLOOD GROUP, RH SYSTEM
Genes (1):
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RHCE (1p36.11)
Methods (1):
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Molecular Genetics - Sequence analysis of the entire coding region: PCR with allele specific hybridization
Target population: Help
Not provided
Clinical validity:
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Not provided
Clinical utility:
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Avoidance of invasive testing
Ordering Information
Offered by:
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Specimen Source:
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- Amniocytes
- Amniotic fluid
- Chorionic villi
- Peripheral (whole) blood
- View specimen requirements
Who can order: Help
- Genetic Counselor
- Health Care Provider
- Licensed Physician
- Nurse Practitioner
Test Order Code:
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CPT codes:
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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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Test service:
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Clinical Testing/Confirmation of Mutations Identified Previously
Genetic counseling
Result interpretation
Genetic counseling
Result interpretation
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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Based on applicable state law
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: 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: 1
Method Category
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Test method
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Instrument *
Sequence analysis of the entire coding region
PCR with allele specific hybridization
* Instrument: Not provided
Clinical Information
Test purpose:
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Monitoring;
Risk Assessment
Clinical utility:
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Recommended fields not provided:
Clinical validity,
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
Test Comments:
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Hemolytic disease of the fetus and newborn (HDFN) results from sensitization of the mother’s immune system to foreign antigens present on the red cells of the fetus. Many red cell antigen systems have been associated with HDFN when incompatibilities exist between the mother and fetus. When a pregnant woman presents …
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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 is >99% for mutations within the coding sequence and intron/exon borders.
Assay limitations:
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Rare variant alleles may not be identified by these assays. Testing parental samples by phenotyping and genotyping is recommended in order to identify discrepancies that may lead to false-negative and false-positive results. Maternal sample is also recommended for maternal contamination studies.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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No
No
Recommended fields not provided:
Test Confirmation,
Citations to support 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
NYS CLEP Approval:
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Number:
Status: Pending
Status: Pending
Additional Information
Reviews:
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.