Spartan Cube CYP2C19 Inter Laboratory Reproducibilty Study

Spartan Bioscience

Status: Completed

Conditions: Genotyping Techniques

Treatments: Device: Spartan Cube CYP2C19 System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04473573

VNV-00227

Details and patient eligibility

About

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).

Full 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.

Enrollment: 8 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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8 participants in 3 patient groups

Lot to Lot Reproducibility

Other group

Description:

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.

Treatment:

Device: Spartan Cube CYP2C19 System

Site to Site Reproducibility

Other group

Description:

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.

Treatment:

Device: Spartan Cube CYP2C19 System

Operator Reproducibility

Other group

Description:

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.

Treatment:

Device: Spartan Cube CYP2C19 System