Spartan Cube CYP2C19 Method Comparison Study
- Conditions
- Genotyping Techniques
- Interventions
- Device: Spartan Cube CYP2C19 System
- Registration Number
- NCT04473586
- Lead Sponsor
- Spartan Bioscience Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 425
- Participants who will provide buccal samples and a saliva sample who have not eaten drank or smoked in the past 30 minutes.
- Participants who have eaten drank or smoked in the past 30 minutes prior to collection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Samples tested greater than 24 hours Spartan Cube CYP2C19 System Buccal samples will be collected, stored and then analyzed on the Spartan Cube CYP2C19 System greater than 24 hours after collection. The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject. Sample tested in less than one-hour Spartan Cube CYP2C19 System Buccal samples will be collected and analyzed on the Spartan Cube CYP2C19 System immediately (\<1hr). The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject.
- Primary Outcome Measures
Name Time Method % Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing Through study completion; anticipated to be less than 4 months Determine % agreement across all tests conducted and bi-directional sequencing results
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mount Sinai Services
🇨🇦Toronto, Ontario, Canada