Evaluation of the LumiraDx Point of Care D-Dimer & CRP Tests

Status Active, not recruiting

Clinical Trial Summary

A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference Analyzer

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04375982
Study type	Interventional
Source	LumiraDx UK Limited
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 20, 2020
Completion date	March 31, 2024

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Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests — NOVEL-3

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms