Performance study of a rapid COVID-19 IVD test
Research type
Research Study
Full title
A Clinical Performance Study using an Optical Fluorescence Test to Detect SARS-CoV-2 Virions
IRAS ID
309237
Contact name
Sue Hagan
Contact email
Sponsor organisation
Paraytec Ltd
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
We are developing a new diagnostic test to find whether people are infected with the virus that causes COVID-19. The hope is that this test will be quicker than the PCR (polymerase chain reaction) test and more reliable than lateral flow tests. So far, we have tested some leftover clinical samples on an earlier version of this test. Now we need to test fresh samples from people where we know how long they have had symptoms and how long it is since they tested positive. This will show how well the test is working and help us improve it. We will also check if the test can find the virus when people swab only their nose, both their nose and throat or swab saliva from their mouth. Once we have checked that everything is working as we expect, we will then do a longitudinal study. This is where the people recruited into the study do swab tests every day for ten days and send us the samples to analyse. They will also do a lateral flow test every day and send us the result. The samples will be tested using the new test, PCR and a lab test to see if the virus can grow from the sample. These tests will show if the COVID-19 virus is found in the samples and we can compare the differences between the four methods. We are also looking to see how well the tests show when each person goes from testing positive to testing negative to give an idea of when they stop being infectious. The study will recruit adult staff members and people that they live with, along with in-patients at Sheffield Teaching Hospitals (STH). People with and without COVID-19 will be able to join the study.
REC name
London - Central Research Ethics Committee
REC reference
22/HRA/1004
Date of REC Opinion
10 May 2022
REC opinion
Further Information Favourable Opinion