N/A
N=327
Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing
Genotyping Techniques
Bottom Line
View on ClinicalTrials.gov: NCT01718535 ↗Enrolled (actual)
327
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Percent Agreement — 100; 100; 100; 100 Percent Agreement
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Spartan FRX CYP2C19 Test System (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Spartan Bioscience Inc.
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Agreement |
100; 100; 100; 100; 100; 100 | — |
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.
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.