An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus During Normal Conditions of Use
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- PPA
研究概览
简要总结
Performance evaluation of QIAstat-Dx® ME Panel Plus using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment
详细描述
The objective of the study is to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment.
The primary objective is to evaluate the performance of QIAstat-Dx® ME Panel Plus in comparison with the results obtained from the reference method.
The secondary objective of the study is to evaluate the safety of QIAstat-Dx® ME Panel Plus with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® ME Panel Plus and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
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
- •Specimen must be Cerebrospinal fluid, obtained via lumbar puncture only.
- •Specimen must be a de-identified residual leftover specimen.
- •Specimen must meet the laboratory testing criteria for individuals with signs and/or symptoms of meningitis and/or encephalitis.
- •Specimens must have a minimum 450 µL of residual volume.
- •Specimen must be unique (only one sample enrolled per patient).
- •Prior to QIAstat-Dx testing, residual CSF specimen must have been stored in accordance with the following:
- •Prospective Fresh:
- •Room temperature (15 °C to 25 °C) for ≤24 hrs
- •Refrigerated (2 °C to 8 °C) for ≤ 7 days
- •Prospective Frozen:
- •-15 ºC to -25 ºC for ≤ 2 months
- •-60 ºC to -90 ºC for ≤ 4 months
- •Retrospective Archived:
- •At the time of QIAstat-Dx testing, specimen must not have undergone more than three (3) freeze/thaw cycles.
- •Prospective Samples Only: Specimen must have been collected on or after the date of prospective study activation at the Clinical collection and testing site.
- •Retrospective Samples Only: Specimens must have a positive diagnosis as per Standard of Care for any of the following viral targets:
- •Herpes simplex virus 1 (HSV-1) Herpes simplex virus 2 (HSV-2) Human herpesvirus 6 (HHV-6) Human parechovirus (HPeV) Varicella zoster virus (VZV) Cytomegalovirus (CMV)
排除标准
- •Residual CSF specimen has been centrifuged.
- •Residual CSF specimen subject identification or label is unclear or missing.
- •Residual CSF specimen container has obvious physical damage.
结局指标
主要结局
PPA
时间窗: 7 months
Positive percent agreement
NPA
时间窗: 7 months
Negative percent agreement
次要结局
未报告次要终点