Spartan Cube CYP2C19 Method Comparison Study

Genotyping Techniques Clinical Trial

Official title: Validation Protocol Spartan Cube CYP2C19- Method Comparison

Status Completed

Clinical Trial Summary

The aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube CYP2C19 system and bi-directional sequencing.

Clinical Trial Description

Sample holding time - two parts

1. Sample tested in less than one-hour

a.In the first part, buccal samples will be collected from subjects and tested using the Spartan Cube CYP2C19 system. These samples will be run immediately (within 1 h) after collection from the subject (<1 h sample holding time). All results will be compared to bi-directional sequencing to determine percent agreement.

2. Sample tested greater than 21 hours a.In the second part (sample holding portion), samples will be tested using the Spartan Cube CYP2C19 product. These samples will be run after storage at ambient temperature. All results will be compared to bi-directional sequencing to determine the percent agreement. ;

Related Conditions & MeSH terms

• Genotyping Techniques

• NCT number: NCT04473586
• Study type: Interventional
• Source: Spartan Bioscience Inc.
• Status: Completed
• Phase: N/A
• Start date: February 5, 2020
• Completion date: March 6, 2020