GTR Test Accession:
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GTR000552067.1
Registered in GTR:
2016-09-20
View version history
GTR000552067.1,
registered in GTR:
2016-09-20
Last annual review date for the lab: 2023-07-12
Past due
LinkOut
At a Glance
Test purpose:
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Prognostic
Conditions (2):
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Early-onset autosomal dominant Alzheimer disease;
Alzheimer disease type 1
Genes (1):
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APOE (19q13.32)
Methods (1):
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Molecular Genetics - Targeted variant analysis: RFLP
Target population: Help
Alzheimer family patients
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 short name:
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APOE
Specimen Source:
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- Peripheral (whole) blood
Who can order: Help
- Health Care Provider
Test Order Code:
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APOE genotype
Contact Policy:
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Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
How to Order:
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Test service:
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Clinical Testing/Confirmation of Mutations Identified Previously
Test additional service:
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Custom mutation-specific/Carrier testing
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: 2
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
Targeted variant analysis
RFLP
Multigene Labnet
Clinical Information
Test purpose:
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Prognostic
Target population:
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Alzheimer family patients
View citations (1)
- Wolters FJ, Koudstaal PJ, Hofman A, van Duijn CM, Ikram MA. Serum apolipoprotein E is associated with long-term risk of Alzheimer's disease: The Rotterdam Study. Neurosci Lett. 2016;617:139-42. doi:10.1016/j.neulet.2016.02.018. Epub 2016 Feb 11. PMID: 26876448.
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
Entire test performed in-house
Analytical Validity:
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142 patients
100% specificity
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:
FDA exercises enforcement discretion
Additional Information
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.