Spartan Cube CYP2C19 Method Comparison Study

Validation Protocol Spartan Cube CYP2C19- Method Comparison

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04473586

Enrollment

425

Registered

2020-07-16

Start date

2020-02-05

Completion date

2020-03-06

Last updated

2020-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genotyping Techniques

Keywords

Method Comparison, CYP2C19

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.

Interventions

DEVICESpartan Cube CYP2C19 System

Using buccal material, determine the genotype of the \*2, \*3 and \*17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Investigator)

Masking description

Bi-directional sequencing results and Spartan results will not be shared with participants. The investigator will not see the bi-directional sequencing results.

Intervention 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.

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
% 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026