Analytical Reproducibility of a Medical Device Clinical Trial
Official title:
Study of the Analytical Reproducibility of the Spartan FRX CYP2C19 *2,*3 and *17 Genotyping System.
The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and *17 genotypes from genomic DNA obtained from buccal swab samples. The objective of the study is to evaluate the performance of the FRX System under multivariate conditions including different days, sites, operators and systems.
The FRX system is comprised of hardware and consumable components. The hardware components
of the system include an Analyzer (thermal cycler with fluorescence detection capability), a
notebook computer and a printer. The consumable component of the FRX system is a sample
collection kit. Each kit contains a buccal swab (used to collect the patient sample) and a
tube containing the reagents required for genomic DNA extraction and PCR (polymerase chain
reaction) amplification stages of the test.
The Spartan FRX System is capable of detecting three CYP2C19 SNPs(single nucleotide
polymorphism) (*2, *3, *17) in each test performed. An individual sample collection kit is
required for each SNP tested; therefore three sample collection kits are required for each
test performed on the system.
To perform a test, the user collects three buccal samples from the patient and then inserts
a sample into each of the three reagent tubes (one for each of the CYP2C19 loci *2, *3 and
*17). The reagent tubes are placed into the Analyzer and the FRX system automates the
processes of DNA extraction, PCR amplification, fluorescent signal detection and data
analysis. The system provides the user with a printed result listing the patient genotypes
at the *2, *3 and *17 loci.
The objective of the study is to evaluate the performance of the FRX System under
multivariate conditions. Specifically, the following variables will be included in the
study:
- Test site - x3
- Operator - x6 (2 per site)
- Day - x15 (5 non-consecutive days per site)
- FRX System - x16
Test performance is defined as the number of correct genotype calls, expressed as a
percentage of the total number of tests performed on the system.
For both the first-pass and second-pass results, 1-sided 95% confidence lower limits will be
calculated using the score method for the % correct calls (i.e. % agreement).
Genotype results from the FRX system will be compared with results of DNA sequencing. The
result of the FRX System test will be determined to be correct if the genotype calls for all
three SNPs are identical to the genotypes determined by DNA sequencing for that
sample/individual.
Results of the Reproducibility Study will be acceptable if the lower bound of a 1-sided 95%
confidence limit of the total correct call rate per genotype is greater than or equal to
95%, based on second-pass results.
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Time Perspective: Prospective