Atrial Fibrillation Clinical Trial
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
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.
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.
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