Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Embolism and Thrombosis
- Infection
- Inflammation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Subjects are asked to provide venous and capillary blood samples which are not being taken as part of routine careMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The purpose of the study is to gather data to determine agreement between sample types, which together with performance evaluation data will be used to support CE marking under Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ...
The purpose of the study is to gather data to determine agreement between sample types, which together with performance evaluation data will be used to support CE marking under Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices 3, using ISO 13612:2002 - Performance Evaluation of In Vitro Diagnostic Medical Devices as the standard. The investigative devices are the LumiraDx Platform D Dimer Test and the LumiraDx Platform CRP Test. The LumiraDx Platform employs a portable diagnostic instrument used with single use D Dimer or CRP Assay Test Strips. Agreement of the different sample types to the reference method will be demonstrated across a patient population representative of the indication for use of the products. Operators will be trained clinical site staff who are representative of the intended users of the product, i.e. health care professionals at the point of care such as nurses, technicians, doctors, etc. A panel of whole blood and plasma samples will be obtained from each patient in order to assess the accuracy of the investigative device across all sample types.
Tracking Information
- NCT #
- NCT04375982
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Judith Kirstein Rancho Paseo Medical Group Principal Investigator: Matthew Morgan Centura Health Physician Group Principal Investigator: Anita Scribner Diagnostic Clinic of Longview Principal Investigator: William Simon New Medical Healthcare
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