Spartan Cube CYP2C19 Inter Laboratory Reproducibilty Study

Spartan Cube CYP2C19 Inter Laboratory Reproducibility Study

The study verifies that the Spartan Cube CYP2C19 System generates reproducible results under multi-variant conditions including test site (three different test sites), operators (two operators per site), testing days (five non-consecutive days per site), and test kit lot (three different lots).

Study Overview

• Status: Completed
• Conditions: Genotyping Techniques
• Intervention / Treatment: Device: Spartan Cube CYP2C19 System

Detailed Description

The reproducibility study (VNV-00227) is aimed at assessing the performance of the Spartan Cube CYP2C19 product under multi-variant conditions that include test site, operators, testing days, and reagent lots. The sections below address how these variables were tested.

This study will be performed by a total of six operators at three test sites. At each site, two operators will conduct buccal sample collection and analysis. Operators include individuals who are technologists, technicians, and/or nurses. The buccal samples will be loaded in the Cube within one hour after buccal swab collection. Furthermore, results will be generated using multiple platforms (Spartan Cube, computer, and printer) and the same platforms will be used at each site. At each site, a total of 64 (8 subjects/operator x 2 operators x 2 sessions x 2 sub-sessions (replicates)) tests will be run on five non-consecutive days. Each day includes 2 sessions and 2 sub-sessions (total 4 collection times) in which samples will be collected. Test subject to platform pairing is not required, results will be generated on one of the platforms per session. This means that each site will generate a total of 320(64 obs./day x 5 days) results over the entire duration of the study.

To determine lot-to-lot reproducibility of test kits, three different lots will be evaluated. For this, two lots will be tested at each site. Each operator will use two lots per session on each testing day. Each replicate only includes a single lot of test kits.

All results generated by the Spartan Cube CYP2C19 System will be compared with the bi-directional sequencing results.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute
    • Ottawa, Ontario, Canada, K1H 8L6
      • Children's Hospital of Eastern Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • The Univeristy of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• available for travel to three different sites, on 5 non-consecutive days.

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lot to Lot Reproducibility; The purpose of this arm is to provide evidence to support that each lot of manufactured reagents for the Spartan Cube CYP2C19 Test produce the same result. Each participant, over the course of the study at the various sites, will be tested using 3 different lots of manufactured Spartan CYP2C19 Test Kits.	Device: Spartan 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.
Other: Site to Site Reproducibility; The purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when tested at different locations, produce the same result.	Device: Spartan 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.
Other: Operator Reproducibility; The purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when collected and tested by different operators, produce the same result.	Device: Spartan 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.

What is the study measuring?

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 6 months

Collaborators and Investigators

• Sponsor: Spartan Bioscience Inc.
• Collaborators: The Ottawa Hospital; Children's Hospital of Eastern Ontario; The University of Ottawa Heart Institute
• Investigators: Principal Investigator: Shaimaa Ahmed, PhD, Spartan Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Actual): March 17, 2020
• Study Completion (Actual): March 17, 2020

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Reproducibility of Results; CYP2C19
• Other Study ID Numbers: VNV-00227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No