NORMAL
Research type
Research Study
Full title
A COMPARISON OF EASE OF USE AND ACCURACY OF RESULT OF THE LUMIRADX POINT OF CARE PLATFORM WHEN USED BY LAY USERS.
IRAS ID
284147
Contact name
Mark Sullivan
Contact email
Sponsor organisation
LumiraDx UK Ltd
Duration of Study in the UK
0 years, 1 months, 19 days
Research summary
This study aims to extend the current CE mark by gathering comparison evaluation data. The instrument and tests in this study have already or will be CE marked before this study starts for use by Healthcare Professionals only. This study provides the data required to extend the CE mark of the product for use by lay-users. It involves Lay users running tests on the device, they will be given a set of instructions to read and a video to watch, explaining how to run the tests. They will then be asked to take a fingerstick of blood, apply it to the instrument, run the test and record the result. A healthcare professional will then repeat this process taking a fingerstick of blood from the lay user to evaluate the ease of use and accuracy of the result obtained. The study aims to show that a lay user can achieve equivalent results to a healthcare professional.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
20/ES/0100
Date of REC Opinion
2 Oct 2020
REC opinion
Further Information Favourable Opinion