COVIDx [COVID-19]
Research type
Research Study
Full title
COVIDx: Evaluation of novel diagnostic tests for 2019-nCOV
IRAS ID
282168
Contact name
Ravindra Gupta
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
COVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. The cases in the United Kingdom continue to increase. 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient’s immune systems. \nAt present, the diagnostic test is a highly specific method of genetic amplification called ‘Reverse Transcription – Polymerase Chain Reaction’ which allows detection of very small amounts of genetic mutations caused by COVID-19. this method must be completed in highly specialised facilities, increasing time to diagnosis, increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), by amplifying genetic material, and Prometheus 2019-nCOV IgG/IgM Test Cassette, by identifying antibodies (both CE marked). \nIn the COVIDx study, 200 patients meeting with suspected COVID-19 will be recruited and a sample from throat and nasal swab taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard care. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibodies. Patients will be followed for clinical outcomes at 28 days post-admission.\nOnce validated, we will move to a second cohort of healthcare workers with the hope of quick identification of infection and maximising the available workforce to combat the pandemic.
REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0109
Date of REC Opinion
2 Apr 2020
REC opinion
Favourable Opinion