Study of the Analytical Reproducibility of the Spartan FRX CYP2C19 *2,*3 and *17 Genotyping System.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Above 16 years of age
- •Must have required genotype
排除标准
- 未提供
结局指标
主要结局
Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.
时间窗: After second pass result is complete (~3h)
Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system. All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is "Inconclusive" for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement).
次要结局
未报告次要终点