NCT04375982

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: LumiraDx UK Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Embolism and Thrombosis
• Infection
• Inflammation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Venepuncture	Blood tube will be collected from standard venepuncture
DIAGNOSTIC_TEST	Fingerstick	Capillary blood will be collected by fingerstick

Timeline

• Start date: 2020-04-20
• Primary completion: 2022-04-05
• Completion: 2024-03-31
• First posted: 2020-05-06
• Last updated: 2023-12-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study