GTR Test Accession:
Help
GTR000576378.2
Last updated in GTR:
2020-05-06
View version history
GTR000576378.2,
last updated:
2020-05-06
GTR000576378.1,
registered in GTR:
2020-05-05
Last annual review date for the lab: 2022-04-25
Past due
LinkOut
At a Glance
Test purpose:
Help
Drug Response
Conditions (3):
Help
Disorder due cytochrome p450 CYP2D6 variant;
CYP2C19-related poor drug metabolism;
Disorder due cytochrome p450 CYP2C19 variant
Genes (2):
Help
CYP2C19 (10q23.33);
CYP2D6 (22q13.2)
Methods (2):
Help
Molecular Genetics - Targeted variant analysis: Allele-specific primer extension (ASPE); PCR
Target population: Help
Not provided
Clinical validity:
Help
Not provided
Clinical utility:
Help
Not provided
Ordering Information
Offered by:
Help
Test Order Code:
Help
511905
How to Order:
Help
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:
Specimen source,
Lab contact for this test,
Contact policy,
Test strategy,
Test development
Conditions
Help
Total conditions: 3
| Condition/Phenotype | Identifier |
|---|
Test Targets
Genes
Help
Total genes: 2
| Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
|---|
Methodology
Total methods: 2
Method Category
Help
Test method
Help
Instrument *
Targeted variant analysis
Allele-specific primer extension (ASPE)
Targeted variant analysis
PCR
* Instrument: Not provided
Clinical Information
Test purpose:
Help
Drug Response
Recommended fields not provided:
Clinical validity,
Clinical utility,
Target population,
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
Entire test performed in-house
Analytical Validity:
Help
Reproducibility: 100%
Accuracy: 100% (compared to sequencing)
Limit of Detection: 4 ng/μL CYP2D6, 2 ng/μL CYP2C19
Interfering Substances: no interference by hemoglobin, bilirubin, albumin, and triglycerides at concentrations tested
View citations (2)
- xTAG® CYP2C19 Kit v3 US-IVD [package insert]. Luminex; MLD-046-KPI-001 Rev E; 2018.
- xTAG® CYP2D6 Kit v3 US-IVD [package insert]. Luminex; MLD-030-KPI-001 Rev G; 2018.
Proficiency testing (PT):
Is proficiency testing performed for this test?
Help
No
No
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
PT Provider,
Description of PT method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
Help
Not provided
Additional Information
Reviews:
Clinical resources:
Molecular resources:
Practice guidelines:
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.