Specimen Collection for Development and Performance Evaluation of the LumiraDx Platform Point of Care Tests for Sars-Cov-2 IgG/IgM & Antigen to be Used as an Aid in Diagnosis of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- Performance of the LumiraDx Assay versus reference methods with regards to clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.
研究概览
简要总结
Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration and performance evaluation for the LumiraDx POC test.
详细描述
CAPTURE is a two-stage sample collection study to complete the development, calibration and performance evaluation phases of the LumiraDx Point of Care (POC) device for the detection of the SARS-CoV-2 virus and the SARS-CoV-2 IgG/IgM status of infected patients. The study is split into two arms targeting separate populations throughout each stage.
Stage 1: Consists of sample collection only, to facilitate the in-house development and calibration of the LumiraDx SARS-CoV-2 assays.
Stage 2: Consists of sample collection to facilitate the performance evaluation of the LumiraDx SARS-CoV-2 studies. In this stage the testing will be completed onsite using the LumiraDx POC device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient is at least 18 years of age.
- •Patient meets either of the below categories:
- •Patient is presenting with symptoms indicative of COVID-19 and will be completing SOC sampling for SARS-CoV-2 PCR testing. (Eligible for Arm A)
- •Patient has had a confirmed positive SARS-CoV-2 PCR test result in the past. (Eligible for Arm B)
排除标准
- •The patient does not have the capacity to consent as determined by the Research Team (and the impartial witness if applicable).
- •The patient is deemed to be unsuitable for research at the research teams' discretion.
结局指标
主要结局
Performance of the LumiraDx Assay versus reference methods with regards to clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.
时间窗: 1 Year approx
Primary Outcome - To collect sufficient SARS-CoV-2 samples (nasal/nasopharyngeal/throat swabs and blood samples) to aid development, calibration and performance evaluation of the LumiraDx POC test. Results will be used to asses performance of the LumiraDx assay versus reference methods with regards to the clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.
次要结局
未报告次要终点