At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Method Comparison Study of the Spartan FRX CYP2C19 *2, *3, and *17 Genotyping System
In Brief
An observational study evaluating Spartan FRX CYP2C19 Test System for Genotyping Techniques. Completed, enrolled 327 participants across 1 site.
Detailed 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.