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CYP2C19 single gene analysis
Clinical Genetic Test
Help
offered by
SPMED CO., LTD
GTR Test Accession: Help GTR000597459.4
PHARMACOGENOMIC
Last updated in GTR: 2024-03-19
View version history
Last annual review date for the lab: 2024-11-03 LinkOut
At a Glance
Test purpose: Help
Drug Response
Conditions (18): Help
Voriconazole response; Amitriptyline response; Aspirin response more...
Genes (1): Help
CYP2C19 (10q23.33)
Methods (1): Help
Molecular Genetics - Sequence analysis of the entire coding region: Bi-directional Sanger Sequence Analysis
Target population: Help
Available for all ethnicity and populations
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
SPMED CO., LTD
View lab's website
Test Order Code: Help
SGAD002
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:
How to Order, Specimen source, Lab contact for this test, Contact policy, Test strategy, Test development
Conditions Help
Total conditions: 18
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 1
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Sequence analysis of the entire coding region
Bi-directional Sanger Sequence Analysis
* Instrument: Not provided
Clinical Information
Test purpose: Help
Drug Response
Target population: Help
Available for all ethnicity and populations
Recommended fields not provided:
Clinical validity, Clinical utility, 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
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
SPMED CYP2C19 gene sequencing method has more than 95% sensitivity (limit of detection), 100% sensitivity for the cut off value, 100% accuracy, 100% precision for repeatability and reproducibility and no cross-reactivity and interference regarding specificity.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
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: Help
Not provided
Additional Information
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.