Development of a rapid, point-of-care, COVID-19 IVD test

  • Research type

    Research Study

  • Full title

    Determination of performance characteristics of an optical fluorescence test for the detection of SARS-Cov2 virions

  • IRAS ID

    289345

  • Contact name

    Carl Smythe

  • Contact email

    c.g.w.smythe@sheffield.ac.uk

  • Sponsor organisation

    University of Sheffield

  • Duration of Study in the UK

    1 years, 0 months, 0 days

  • Research summary

    We are developing a new test to find COVID-19 virus in samples taken from people. The hope is that this test will be far quicker than the current “gold standard” method used right now. We have created a first version (prototype) of this diagnostic test and this study is to find out how well it is working and help us improve it. To do this, we will test several samples and then perform statistical analyses on the results to see whether the COVID-19 virus is detected or not. These statistical measures are standard and will allow us to compare our prototype to other COVID-19 test methods and to modify our test to improve its performance. This project will use leftover samples that have already been collected in routine screening of staff at Sheffield Trust Hospitals. These samples have already been tested at the hospital for COVID-19 to find out if parts of the virus are present or not. These results can be compared to the new faster prototype to check how accurate it is. As we develop the prototype further, we will then test further samples to check for improvement.

  • REC name

    Wales REC 7

  • REC reference

    20/WA/0340

  • Date of REC Opinion

    27 Nov 2020

  • REC opinion

    Favourable Opinion