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Capillary Zone Electrophoresis (Sebia)
Clinical Genetic Test
Help
offered by
Hemoglobinopathy Reference Laboratory
GTR Test Accession: Help GTR000560995.1
CAP
INHERITED DISEASEHEMATOLOGYENDOCRINOLOGY ... View more
Registered in GTR: 2018-06-29
View version history
Last annual review date for the lab: 2024-08-14 LinkOut
At a Glance
Test purpose: Help
Monitoring; Screening
Conditions (10): Help
Hemoglobinopathy; FETAL HEMOGLOBIN QUANTITATIVE TRAIT LOCUS 6; Fetal hemoglobin quantitative trait locus 1 more...
Genes (4): Help
HBA1 (16p13.3); HBA2 (16p13.3); HBB (11p15.4); HBD (11p15.4)
Methods (1): Help
Biochemical Genetics - Protein analysis: Electrophoresis
Target population: Help
The Sebia Capillarys system was approved by the US Food …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Hemoglobinopathy Reference Laboratory
View lab's website
Manufacturer's name: Help
Sebia
Specimen Source: Help
  • Cord blood
  • Fetal blood
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
Contact Policy: Help
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: Help
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Result interpretation
Test development: Help
FDA-reviewed (has FDA test name)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code, Lab contact for this test, Test strategy
Conditions Help
Total conditions: 10
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 4
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Protein analysis
Electrophoresis
* Instrument: Not provided
Clinical Information
Test purpose: Help
Monitoring; Screening
Target population: Help
The Sebia Capillarys system was approved by the US Food and Drug Administration (FDA) for hemoglobinopathies.
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: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
It is 100%
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
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, 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: Help
Category: IVD - In Vitro Device.
FDA Review of (Item reviewed): Instrument(s)
FDA Regulatory Status: FDA cleared/approved
Additional Information

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