GTR Test Accession:
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GTR000521865.8
CAP
Last updated in GTR: 2022-10-25
View version history
GTR000521865.8, last updated: 2022-10-25
GTR000521865.7, last updated: 2022-06-09
GTR000521865.6, last updated: 2021-01-08
GTR000521865.5, last updated: 2018-02-16
GTR000521865.4, last updated: 2016-03-03
GTR000521865.3, last updated: 2015-07-27
GTR000521865.2, last updated: 2015-07-20
GTR000521865.1, last updated: 2015-03-18
Last annual review date for the lab: 2023-06-08
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At a Glance
Test purpose:
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Monitoring;
Risk Assessment;
Diagnosis
Conditions (1):
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Duffy Blood group system
Genes (1):
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ACKR1 (1q23.2)
Methods (2):
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Molecular Genetics - Targeted variant analysis: Allele-specific primer extension (ASPE); PCR with allele specific hybridization
Target population: Help
Expectant women with an identified anti Fya or Fyb antibody …
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
- Nurse Practitioner
- Licensed Physician
- Health Care Provider
- Genetic Counselor
Test Order Code:
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CPT codes:
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Lab contact:
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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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Result interpretation
Genetic counseling
Clinical Testing/Confirmation of Mutations Identified Previously
OrderCode: 4405
Genetic counseling
Clinical Testing/Confirmation of Mutations Identified Previously
OrderCode: 4405
Test development:
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Test developed by laboratory (no manufacturer test name)
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:
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: 2
Method Category
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Test method
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Instrument
Targeted variant analysis
Allele-specific primer extension (ASPE)
Other
Targeted variant analysis
PCR with allele specific hybridization
Clinical Information
Test purpose:
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Monitoring;
Risk Assessment;
Diagnosis
Clinical utility:
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Target population:
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Expectant women with an identified anti Fya or Fyb antibody in their serum
Recommended fields not provided:
Clinical validity,
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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Mutations that are outside the regions sequenced will not be detected. 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.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Recommended fields not provided:
Test Confirmation,
Citations to support assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
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:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.