NCT06360757终止不适用
Multi-Center Clinical Performance Evaluation of the NeuMoDx SARS-CoV-2 Assay on the NeuMoDx Molecular Systems
QIAGEN Gaithersburg, Inc1 个研究点 分布在 1 个国家目标入组 503 人开始时间: 2024年2月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- Sensitivity as compared to the comparator method
研究概览
简要总结
A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems.
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
- •Any de-identified NP swab specimen in transport medium from a symptomatic individual suspected of COVID-19 at the time of collection.
- •NP swab specimens obtained using a flexible mini-tip flocked swab and collected into 3mL Copan UTM [Cat. No. 305C] or BD UVT [Cat. No. 220531].
- •Prospective specimens, fresh (Category I) shall be tested within:
- •(4) hours when held at room temperature, or
- •(3) days when held at (2 to 8°C), with cold storage starting within (4) hours of collection.
- •Minimum volume of ≥ 2mL.
排除标准
- •Required information unable to be obtained from the associated medical chart.
- •Specimens that remained on-board the NeuMoDx System for > (8) hours prior to processing.
结局指标
主要结局
Sensitivity as compared to the comparator method
时间窗: Through study completion estimated 9 months
Sensitivity ≥ 95% with a lower bound of the two-sided 95% CI \> 90%
次要结局
- Specificity(Through study completion estimated 9 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus AureusStaphylococcus AureusNCT00406549Solventum US LLC2,000
进行中（未招募）
2 期
Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)COVID-19 PneumoniaNCT04317092National Cancer Institute, Naples402
已完成
不适用
ARDA Software for the Detection of mtmDRDiabetic RetinopathyNCT04905459Verily Life Sciences LLC1,012
招募中
不适用
Evaluation of Safe Use of SECURIDRAP® SELFIA®DisorientationCognitive ImpairmentBehavior DisordersNCT05510401Groupe Mulliez-Flory108
已完成
2 期
Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic SubjectsDyspeptic SubjectsNCT01677338Otsuka Pharmaceutical Co., Ltd.20