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Completed

NCT Number: NCT04473573

Spartan Cube CYP2C19 Inter Laboratory Reproducibilty 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).

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Key information

Conditions

Genotyping Techniques

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

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.

Primary outcomes

  1. % Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing

    Time frame: Through study completion; anticipated to be less than 6 months

    Determine % agreement across all tests conducted and bi-directional sequencing results

Sponsors and collaborators

Lead sponsor

Spartan Bioscience Inc.

Industry

Collaborators

  • Children's Hospital of Eastern Ontario
  • The Ottawa Hospital
  • The University of Ottawa Heart Institute

Registry information

Official study title

Spartan Cube CYP2C19 Inter Laboratory Reproducibility Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2020
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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