Spartan Cube CYP2C19 Inter Laboratory Reproducibilty Study

NCT04473573 | Completed

• 1 other identifier: VNV-00227
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Genotyping Techniques

Keywords

Reproducibility of Results; CYP2C19

Outcome Measures

Primary Outcomes (1)

• % 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

Study Arms (3)

Lot to Lot Reproducibility

OTHER

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

Site to Site Reproducibility

OTHER

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

Operator Reproducibility

OTHER

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

Interventions

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.

Lot to Lot Reproducibility; Operator Reproducibility; Site to Site Reproducibility

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Spartan Bioscience Inc.: lead
• Children's Hospital of Eastern Ontario: collaborator
• The Ottawa Hospital: collaborator
• The University of Ottawa Heart Institute: collaborator

Study Sites (3)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L6, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

The Univeristy of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Study Officials

• Shaimaa Ahmed, PhD

  Spartan Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Bi-directional sequencing results will not be shard with the participants, operators or Principal investigators.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects receive the same number and type of test for the duration of the study.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: October 31, 2019
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)