OPTIMAL v3.2
Research type
Research Study
Full title
Evaluation of the precision and accuracy of international normalised ratio (INR) measurements as assessed by Lumiradx instrument in a point of care setting with multiple operators
IRAS ID
232773
Contact name
Karen Lang
Contact email
Sponsor organisation
LumiraDx
Duration of Study in the UK
0 years, 0 months, 26 days
Research summary
A performance evaluation study designed to assess the precision and accuracy of the LumiraDx point of care in vitro diagnostic system. The lumiraDx system consists of a portable diagnostic meter in conjunction with single use analyte test strips, for the quantitative determination of Prothrombin Time as expressed as International Normalised Ratio (INR), as sampled from individuals evaluated for INR at the point of care. Results obtained from the LumiraDx system will be compared to results of a "gold standard" system to assess accuracy, but will not be used to influence patient care in any way during this study.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0161
Date of REC Opinion
30 Jan 2018
REC opinion
Further Information Favourable Opinion