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COMPLETED
NCT03682419

Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device

Sponsor: LumiraDx UK Limited

View on ClinicalTrials.gov

Summary

Comparison of capillary whole blood INR determined by LumiraDx Instrument to venous plasma INR determined by laboratory reference method (IL ACL ELITE PRO) for method comparison and assessment of accuracy and bias by regression analysis and other analytical methods.

Official title: Evaluation of the Precision and Accuracy of International Normalised Ratio (INR) Measurements as Assessed by the LumiraDx Instrument in a Professional Point of Care Setting With Multiple Operators

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

420

Start Date

2018-09-17

Completion Date

2018-11-23

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

PROCEDURE

VKA Patients

Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy

PROCEDURE

Non-VKA Patients

Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy

Locations (3)

Glasgow Royal Infirmary Clinical Research Facility

Glasgow, United Kingdom

Golden Jubilee National Hospital

Glasgow, United Kingdom

Wishaw General Hospital, NHS Lanarkshire

Wishaw, United Kingdom