Resp-RaTE
Research type
Research Study
Full title
Respiratory Infections - Rapid Test Evaluation: a platform study for clinical validation of novel rapid devices in respiratory infection
IRAS ID
298952
Contact name
Graham Cooke
Contact email
Sponsor organisation
Research Governance and Integrity Team, Imperial College London
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
Point of care devices offer a novel approach to rapid diagnosis of respiratory infections and identification of viral mutations, as has been demonstrated by the success of some technologies developed and implemented during the SARS-CoV-2 pandemic. This is a platform study to allow for the rapid analysis of new rapid testing devices in comparison to conventional lab based diagnostic methods.
The study will recruit patients >18 year or older with a confirmed or suspected respiratory infection (depending on specific device being tested) or staff members presenting to a testing facility and will involve taking 1-2 samples of one or more of saliva/sputum sample/ naso/ nasopharyngeal swab. One sample will be run on the point of care device and compared to standard lab based diagnostics. (Where lab based diagnostics results are not available as part of clinical care, we will take an extra sample for the study team to run for comparison with POCT.) We will also ask patients to consent to collection of data on their demographics, past medical history and medications where appropriate, or in the case of staff members we may ask them to fill out a questionnaire. Written informed consent will be obtained from each participant.
The primary outcome of the study will be to analyse the diagnostic accuracy of the POCT device in question compared to standard laboratory testing, determined by sensitivity, specificity and positive and negative predictive values. Secondary outcomes will be acceptability and feasibility of use.
REC name
Wales REC 7
REC reference
21/WA/0338
Date of REC Opinion
10 Jan 2022
REC opinion
Further Information Favourable Opinion