CAPTURE (COVID-19) [COVID-19]
Research type
Research Study
Full title
Specimen Collection for Development and Performance Evaluation of the LumiraDx Platform Point of Care Tests for Sars-Cov-2 IgG/IgM & Antigen to be used as an Aid in Diagnosis of COVID-19
IRAS ID
282521
Contact name
Samer Elkhodair
Contact email
Sponsor organisation
LumiraDx Technology Ltd
Duration of Study in the UK
2 years, 0 months, 16 days
Research summary
CAPTURE is a two-stage sample collection study to complete the development, calibration and performance evaluation phases of the LumiraDx Point of Care (POC) device for the detection of the SARS-CoV-2 virus and the SARS-CoV-2 IgG/IgM status of infected patients. The study is split into two arms targeting separate populations throughout each stage.\n\nStage 1 consists of sample collection only, to facilitate the in-house development and calibration of the LumiraDx SARS-CoV-2 assays. \n\nStage 2 consists of sample collection to facilitate the performance evaluation of the LumiraDx SARS-CoV-2 studies. In this stage the tests will be completed onsite using the LumiraDx POC device.\n\nArm A targets patients with suspected COVID-19 and involves taking a swab sample in line with the sites Standard of Care swabbing method along with collection of whole blood and plasma samples.\n\nArm B targets patients who have previously tested positive and uses capillary fingerstick, whole blood and plasma samples. \n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0139
Date of REC Opinion
14 Apr 2020
REC opinion
Further Information Favourable Opinion