NCT05305534已完成不适用
Clinical Performance Evaluation Study of the QIAstat-Dx® BCID GN and GPF Plus AMR Panels on Positive Blood Culture and Pure Colony Isolates From Subjects With Signs and Symptoms of Bloodstream Infection
QIAGEN Gaithersburg, Inc1 个研究点 分布在 1 个国家目标入组 2,142 人开始时间: 2023年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,142
- 试验地点
- 1
- 主要终点
- NPA
研究概览
简要总结
Study for performance evaluation of the QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel in comparison with other chosen comparator methods
详细描述
This multicenter study aims to evaluate the performance of QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel with another validated comparator method.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive (as identified through Gram stain) blood culture media specimens cultured within bottle types listed in IFU.
- •Residual and de-identified specimens.
- •Specimen from subject who has not previously been enrolled.
- •Fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity.
- •Frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity.
- •Minimum 1.5 mL volume available
- •In stage 2 - Pure colony isolates of Bacilli, Actinobacteria, fungi (except Fusarium), Enterobacterales, Pseudomondales, Nesseriales, Pasteurellales, Bacterioidales, or Xanthomonadales.
排除标准
- •Positive Blood Culture specimens inoculated with a sample type other than Blood (i.e. Paracentesis, or other body fluids)
- •Specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected).
- •Frozen specimens which are unable to be cultured after thawing.
- •Specimen from subject previously enrolled
结局指标
主要结局
NPA
时间窗: 6 moths
negative percentage agreement
PPA
时间窗: 6 moths
positive percentage agreement
次要结局
未报告次要终点
研究者
研究点 (1)
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