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

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis; Thrombophilia; Antiphospholipid Syndrome; Atrial Fibrillation; Post-Myocardial Infarction Syndrome; Artificial Heart Device User; Pulmonary Embolism

• Registration Number: NCT03682419
• Lead Sponsor: LumiraDx UK Limited

Brief 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.

Detailed Description

A performance evaluation study designed to assess the precision and accuracy of the LumiraDx Instrument, a point of care in vitro diagnostic system employing a portable diagnostic meter in conjunction with single use analyte test strips, for the quantitative determination of Prothrombin Time expressed as International Normalised Ratio (INR), as sampled from individuals evaluated for INR at the point of care (POC).

The accuracy of the LumiraDx Instrument INR results will be assessed by, in the first instance, comparison to the INR results obtained from the same individuals as analysed by trained laboratory professionals using the paired venous plasma samples in the reference device IL ACL ELITE PRO Coagulation Analyzer. The accuracy of INR measurements of capillary whole blood across the range of haematocrit (25% - 55%) will be assessed using paired haematocrit results obtained from the HemoCue Hb 201+ on venous whole blood. The results of these evaluations are intended to be used for regulatory filings for the LumiraDx Instrument and LumiraDx INR test as an in vitro diagnostic test in the European Union (EU) and other relevant geographies. For information only, the accuracy of the LumiraDx Instrument INR Test will also be assessed by comparison to INR results from an alternative point of care instrument, the Roche Coaguchek PRO II.

Adult males and females currently in receipt of vitamin K antagonist therapy will be included on the study. Approximately 500 subjects will be recruited to ensure that sufficient suitable subjects are enrolled and to allow for a small level of exclusions. The power calculation as well as recommendations of the FDA CLIA Waiver Guidance document (1) requires a minimum of 360 valid subjects in total (inclusive of non-therapy subset). A subsection of the subject population (\~50 subjects) will consist of adult males and females who fulfil all other study inclusion criteria but are not in receipt of vitamin K antagonist therapy. This will be done in order to test the lower measurement limit of the LumiraDx Instrument INR test. At the end of the study the Healthcare Professional will be asked to complete a User Acceptability Questionnaire which is intended to assess the acceptability of the LumiraDx INR system in terms of ease of use.

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-17
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-24
• Primary Completion: 2018-11-23
• Study Completion: 2018-11-23
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the clinical performance of the LumiraDx instrument	8 weeks	Measurement of INR using Capillary \& Venous blood samples

Secondary Outcome Measures

Name	Time	Method
To determine the accuracy of the LumiraDx instrument	8 weeks	Measurement of INR \& Haematocrit using Capillary \& Venous blood samples

Trial Locations

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