Spartan Cube CYP2C19 Method Comparison Study

Study Overview
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Brief Summary
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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
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Sample holding time - two parts 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. 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.

Official Title
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Validation Protocol Spartan Cube CYP2C19- Method Comparison

Conditions
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Genotyping Techniques

Intervention / Treatment
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* Device: Spartan Cube CYP2C19 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who will provide buccal samples and a saliva sample who have not eaten drank or smoked in the past 30 minutes. Exclusion Criteria: Participants who have eaten drank or smoked in the past 30 minutes prior to collection.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will experienced the same number of buccal and saliva samples collected. This means all subjects will participate in Arm 1 and have materials collected at the same time in the event they are enrolled in arm 2. Based on enrollment numbers and their immediate genotype, it will be determined at that time if the subject will participate in the second arm of the study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sample tested in less than one-hour<br>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. | Device: Spartan Cube CYP2C19 System<br>* Using buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.<br>|
| Other: Samples tested greater than 24 hours<br>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. | Device: Spartan Cube CYP2C19 System<br>* Using buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing | Determine % agreement across all tests conducted and bi-directional sequencing results | Through study completion; anticipated to be less than 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Method Comparison, CYP2C19