N/A
Completed N=327
Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing
Genotyping Techniques
Source: ClinicalTrials.gov NCT01718535 ↗
Enrolled (actual)
327
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Percent Agreement — 100; 100; 100; 100 Percent Agreement
Summary
The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and *17 genotypes from genomic DNA obtained from buccal swab samples. This study is purposed to demonstrate the concordance (positive and negative percent agreement) by comparing the Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the concordance between three different sample transport embodiments provided to laboratories for use in transporting the reagent tubes with collected buccal sample swab to the laboratory.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Agreement |
100; 100; 100; 100; 100; 100 | — |
Eligibility Criteria
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT01718535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.