Somerset NHS Foundation Trust Coronavirus Antigen Testing (SOCRATES) [COVID-19]
Research type
Research Study
Full title
Evaluation of the PCL rapid point of care antigen test for Severe Acute Respiratory Syndrome Coronavirus 2
IRAS ID
283137
Contact name
Justin Pepperell
Contact email
Sponsor organisation
Somerset NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 24 days
Research summary
This study is to validate the utility of the PCL COVID-19 Ag Rapid FIA test in a real world clinical setting. This test has already completed laboratory testing. \n\nThis study will test the practical delivery of the test in terms of time constraints and error rates and the objective performance compared to current standard diagnostic test for COVID-19. \n\nWe will recruit patients with symptoms of COVID-19 having a SARS CoV-2 PCR test and additionally test them with the PCL COVID-19 Ag Rapid FIA test in parallel. We aim to study 200 patients across Somerset NHS Foundation Trust. The results will not be used to guide decision making. Patients having a COVID PCR test will be asked to read the patient information sheet and asked if they would like to participate. The patients will have a second swab taken at the time of sampling for the standard COVID PCR test. Participant consent will also be sort to store plasma samples from remaining blood samples taken for routine clinical care. The patient will have no additional interventions. \n\nWe will report results of the on site clinical diagnostic test and the PCL COVID-19 Ag Rapid FIA test with the number of the kit used, the buffer solution and the test date. Anonymised information about year of birth, gender and place of testing will be collected alongside date of symptom onset, symptoms and immunodeficiency status or significant conditions.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
20/YH/0208
Date of REC Opinion
14 Jul 2020
REC opinion
Further Information Favourable Opinion