Point-of-care testing for COVID-19 in adults presenting to hospital [COVID-19]
Research type
Research Study
Full title
Evaluating the clinical impact of routine molecular point-of-care testing for COVID-19 in adults presenting to hospital: A prospective, interventional, non-randomised pre and post implementation study (CoV-19POC)
IRAS ID
280621
Contact name
Tristan Clark
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
ISRCTN Number
ISRCTN14966673
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Coronavirus disease 2019 or COVID-19 is an infectious disease caused by SARS-CoV-2, a novel coronavirus closely related to the SARS virus. The World Health Organisation (WHO) declared COVID-19 to be a Public Health Emergency of International Concern on the 30th of January 2020. At the time of writing there have been nearly 90,000 confirmed cases worldwide with nearly 3000 deaths worldwide involving over 50 countries.\n\nThere have been over 50 confirmed cases in the UK so far and thousands have been tested. It seem likely that the virus will continue to spread causing a full scale pandemic and that the UK will see many more suspected and confirmed cases over the coming weeks and months.\n\nWe will undertake a prospective, interventional, non-randomised, pre and post implementation study of mPOCT for COVID-19 in adults presenting to University Hospital Southampton NHS Foundation Trust. In the initial pre-implementation phase of the study we will collect data on patient management and outcomes in patients tested with standard laboratory RT-PCR testing for suspected SARS-CoV-2. \n\nA brief validation and training phase will be followed by the post-implementation phase where patients will be recruited and tested at the point-of-care using the QIAstat-Dx Respiratory 2019-nCoV Panel (which includes an assay for SARS-CoV-2). \n\nWe shall test in our hospital patients presenting to our large teaching hospital with acute respiratory illness with this point-of-care test as the outbreak becomes more widespread in the UK.\n\nClinical and infection control teams will be informed of these results in real time. Outcome measures will be by assessed by retrospective case note analysis and will include: time to result, time in negative pressure isolation facility, detection of COVID-19 cases not initially suspected (based on current PHE case definition), antibiotic use, antiviral use, length of hospital stay, ward closures and hospital resource use.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
20/SC/0138
Date of REC Opinion
14 Mar 2020
REC opinion
Further Information Favourable Opinion