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| Name | Class |
|---|---|
| Mount Sinai Services | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sample tested in less than one-hour | Other | 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. |
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| Samples tested greater than 24 hours | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spartan Cube CYP2C19 System | Device | Using buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaimaa Ahmed, PhD | Spartan Bioscience Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Services | Toronto | Ontario | M5G1Z5 | Canada |
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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.
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Bi-directional sequencing results and Spartan results will not be shared with participants. The investigator will not see the bi-directional sequencing results.