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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
425
Using buccal material, determine the genotype of the \*2, \*3 and \*17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.
Mount Sinai Services
Toronto, Ontario, Canada
% 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
Time frame: Through study completion; anticipated to be less than 4 months
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