Spartan Cube CYP2C19 Inter Laboratory Reproducibilty Study

Genotyping Techniques Clinical Trial

Official title:

Spartan Cube CYP2C19 Inter Laboratory Reproducibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473573
• Other study ID #: VNV-00227
• Status: Completed
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: March 17, 2020

Study information

• Verified date: July 2020
• Source: Spartan Bioscience Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Genotyping Techniques

Intervention

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.

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	The Univeristy of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Spartan Bioscience Inc.	Children's Hospital of Eastern Ontario, The Ottawa Hospital, The University of Ottawa Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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