UKHSA IVDD Testing Evaluation Framework
Research type
Research Study
Full title
UK Health Security Agency (UKHSA) standardised protocol for clinical studies evaluating the safety and performance of In-vitro Diagnostic Devices (IVDD) for use in the Covid-19 and other national infectious diseases testing programmes.
IRAS ID
317913
Contact name
Tom Fowler
Contact email
Sponsor organisation
UKHSA
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The UK Health Security Agency (UKHSA) introduced a national infectious diseaseCovid-19 testing programme across the UK population. At the beginning there were no licensed tests for Covid-19, UKHSA worked with manufacturers and suppliers of test kit components to manufacture new testing devices. UKHSA has worked in collaboration with the UK biotechnology industry to develop national diagnostics manufacturing capabilities. The aim was to ensure the UK had a continuous supply of high-quality in-vitro diagnostic tests to meet the demands of a national pandemic.
The rapid development of tests in response to an urgent public health threat may mean that new tests need to be developed quickly. the tests do not have the normal checks/studies to confirm the degree of accuracy of the tests in larger populations or over longer periods of time, and those studies that are conducted by manufacturers may be based on small numbers of samples, so it is important to confirm that they perform adequately when used in larger populations and as diseases change or mutate. It is essential we have the capability to rapidly develop and validate tests for public us in future infectious disease outbreaks where there are no suitable commercially available tests.
We aim to ensure that the tests used in national infectious diseases testing programmes are of a high standard of diagnostic accuracy and that UK resources are used wisely. We do this by studying:
• The accuracy of the tests used, or planned to be used, within national testing programmes.
• The effectiveness of the ways we deliver testing.
• Whether the tests, or where relevant sample collection kits, are safe and relatively easy for people to use.REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0340
Date of REC Opinion
28 Sep 2022
REC opinion
Further Information Favourable Opinion