A Performance Evaluation of the LumiraDx Point of Care CRP Assay.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 3
- 主要终点
- To determine the performance of the LumiraDx POC CRP assay when compared to the Siemens Dimension Xpand Plus CRP in patients with symptoms of infection, inflammation, or injury.
研究概览
简要总结
In patients with symptoms of infection, tissue injury and inflammatory disorders the study will evaluate agreement between the CRP measurements from the LumiraDx POC CRP assay and the Siemens Dimension Xpand Plus CRP assay, as an aid in evaluation and detection of infection, tissue injury and inflammatory disorders.
详细描述
This is a performance evaluation study designed to assess the precision and accuracy of the LumiraDx point of Care (POC) C-reactive Protein (CRP) test when used in patients presenting with symptoms of infection, tissue injury or inflammatory disorder.
The LumiraDx POC CRP test is a quantitative immunoassay providing results in under 10 minutes. The accuracy of the LumiraDx POC CRP test will be assessed using capillary whole blood, venous blood, and plasma samples, by comparison to the CRP results obtained from the same individuals as analysed by trained laboratory professionals using the reference device, Siemens Dimension Xpand Plus CRP assay. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the UK, European Union (EU) and other relevant geographies.
Adults (aged 18 and over at time of consent) presenting to the study sites with symptoms of infection, tissue injury or inflammatory disorder will be included in the study. Approximately 250 patients will be recruited to ensure that sufficient suitable patients are enrolled and to allow for a small level of exclusions.
After obtaining informed consent, blood tube samples will be drawn and fingerstick samples of capillary blood will be taken from the subject, these will be applied directly onto unique test strips for immediate measurement of CRP on the LumiraDx POC instrument.
The CRP results obtained via the LumiraDx CRP test will be used in a set of comparative analyses designed to determine the performance characteristics of the test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years and over at the time of consent
- •Willing and able to provide written informed consent and comply with study procedures
- •Presenting with symptoms of infection, tissue injury, inflammatory disorders. This includes but not limited to : respiratory tract infection (upper and lower), rheumatoid arthritis, Lupus, burns, trauma, inflammatory bowel disease.
排除标准
- •The patient is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic or drug including either treatment or therapy.
- •Skin lesions or conditions that would preclude a fingerstick and/or a venous blood draw.
- •Patient has previously participated in this study
- •Any patient with critical illness or requiring a time critical intervention
- •Patient with end of life or palliative care
- •Patient suffering from the following conditions: Myeloma, monoclonal gammopathy, extreme lipaemia
- •Patient is deemed medically unfit to participate.
研究组 & 干预措施
Symptoms of inflammation, Infection, tissue injury
Venous blood draw of up to 24mL and up to 6 capillary fingersticks
干预措施: Venepuncture (Diagnostic Test)
Symptoms of inflammation, Infection, tissue injury
Venous blood draw of up to 24mL and up to 6 capillary fingersticks
干预措施: Fingerstick (Diagnostic Test)
结局指标
主要结局
To determine the performance of the LumiraDx POC CRP assay when compared to the Siemens Dimension Xpand Plus CRP in patients with symptoms of infection, inflammation, or injury.
时间窗: 2 months
Measurement of blood samples from patients with symptoms of inflammation, infection or injury in a reference method and in the LumiraDx method to assess accuracy of the LumiraDx method
次要结局
未报告次要终点