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) [Protocol]

Trial siteSouthampton General Hospital, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, UK.Trial locationsEmergency department (ED), Acute Medical Unit (AMU), Respiratory High Dependency Unit (RHDU), General Intensive Care Unit (GICU), medical wards and other locations, within University Hospital Southampton NHS Foundation Trust (UHS).AimTo evaluate the clinical impact and real-world diagnostic accuracy of routine molecular point-of-care testing for respiratory viruses including SARS-CoV-2 (the cause of COVID-19) in adults presenting to hospital with suspected COVID-19 and/or acute respiratory illness (ARI).DesignNon-randomised, interventional, pre and post implementation study.PopulationAdults aged 18 years old and over presenting to hospital with suspected COVID-19 and/or ARI.Sample Size500 participants.InterventionCombined nose and throat swab (and lower respiratory tract samples where available) tested by QIAGEN QIAstat-Dx Respiratory 2019-nCoV Panel for SARS-CoV-2 and other respiratory viruses with results communicated to clinical and infection control teams in real time.Control (pre-implementation)Routine clinical care with testing for SARS-CoV-2 by laboratory RT-PCR performed in regional Public Health England (PHE) laboratory.Key AssessmentEvaluation of clinical outcome measures, implementation feasibility, and real-world diagnostic accuracy.Timing12 months: April 2020 to April 2021 (with 6 months for patient recruitment) Plus a further five years after patient recruitment has ended for data and laboratory analysis of specimens