SeCore Sequencing Kit and 3500xl Dx Genetic Analyzer Clinical Performance Testing vs. SSP UniTray
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
研究概览
简要总结
The purpose of this study is to compare the Invitrogen SeCore(R) sequencing system and uTYPE(R) interpretation software to the predicate device Invitrogen SSP UniTray(R) with UniMatch(R) interpretation software and show 95% concordance with 90% confidence.
详细描述
Testing will be performed on A, B, C, DRB1, DRB3/4/5, DQB1, and DPB1 loci. Additionally, testing will be performed using the following locus specific Group Specific Sequencing Primers: A, B, Cw, DPB1, DQB1 and DRB.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Deidentified leftover blood samples
排除标准
- 未提供
结局指标
主要结局
SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
时间窗: 10 weeks
SeCore Kit, A Locus,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
时间窗: 10 weeks
the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
时间窗: 10 weeks
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)
时间窗: 10 weeks
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)
时间窗: 10 weeks
SeCore® Kit, B Locus (Single Amp), The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.
SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
时间窗: 10 weeks
SeCore® Kit, C Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.
SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)
时间窗: 10 weeks
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)
时间窗: 10 weeks
All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
时间窗: 10 weeks
SeCore® DPB1 Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
次要结局
未报告次要终点