Clinical Trials Directory

Trials / Completed

CompletedNCT03682419

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
420 (actual)
Sponsor
LumiraDx UK Limited · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREVKA PatientsVenepuncture and capillary blood collection from Patients receiving Warfarin Therapy
PROCEDURENon-VKA PatientsVenepuncture and capillary blood collection from Patients not receiving Warfarin Therapy

Timeline

Start date
2018-09-17
Primary completion
2018-11-23
Completion
2018-11-23
First posted
2018-09-24
Last updated
2019-02-27

Locations

3 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03682419. Inclusion in this directory is not an endorsement.