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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Edward Blandford
+44 (0)7974 019145
edward.blandford@ukhsa.gov.uk


Study Location:

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Be Part of Research - Trial Details - UKHSA framework study for evaluating the safety and effectiveness of devices and new testing methods for diagnosing COVID-19 and other infectious diseases
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UKHSA framework study for evaluating the safety and effectiveness of devices and new testing methods for diagnosing COVID-19 and other infectious diseases

Recruiting

Open to: All Genders

Age: Mixed

London London London

Medical Conditions

COVID-19 and other infectious diseases

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


During the early stages of the SARS-CoV-2 pandemic, The UK Health Security Agency (UKHSA) introduced a national infectious disease (including Covid-19) testing programme. This involved the UKHSA directly delivering Covid-19 testing across the UK population. In the beginning, there were no licensed tests for Covid-19 and therefore, UKHSA worked with manufacturers and suppliers of test kit components to manufacture new testing devices. Since then, UKHSA has worked in collaboration with the UK biotechnology industry to develop national diagnostics manufacturing capabilities. The aim of which was to ensure that 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. As such, 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 over time. It is also essential to ensure that we have the capability to rapidly develop and validate tests for public use 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 will do this by studying:
The accuracy of the tests used or planned to be used, within national testing programmes.
The effectiveness of the ways in which we deliver testing.
Whether the tests or where relevant sample collection kits, are safe and relatively easy for people to use.

This framework protocol ensures that these studies can be delivered quickly and safely, under one standardised ethical and governance framework, to inform key policy decisions, support the development of improved testing approaches and provide assurance of the clinical effectiveness of UKHSA testing programmes.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Jan 2023 15 Jun 2027

Publications

2025 Interim results article in https://pubmed.ncbi.nlm.nih.gov/39806484/ (added 20/01/2025)

Participants are asked to take part in an evaluation study which will allow the research team to check the performance of tests and improve how they are used. We will provide participants with some tests or sampling kits, together with a step-by-step guide on how to take the test or provide a sample. The test may need to be registered and some additional information provided but the requirement for extra testing or information collection has been kept to a minimum and will be as close to normal care as possible. Laboratory studies completed using the provided samples may also help researchers understand more about the disease which can assist them in developing new vaccines, treatments, tests and other public health responses.


Individuals who are known, or suspected, to have an infectious disease which is the subject of a UKHSA National Testing Programme, contacts of such individuals, or any individual who is at risk of contracting the disease in question (e.g. healthcare workers, hospital inpatients, etc)

You can take part if:



You may not be able to take part if:


1. Participants who cannot provide informed consent and do not have an identified caregiver who can provide consent on their behalf.2. Individuals for whom the caregiver, healthcare worker, or physician stipulates the process of sample collection is clinically unsuitable.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University College London Hospital
    University College London Hospitals NHS Foundation Trust 250 Euston Road
    London
    NW1 2PG
  • Chelsea & Westminster Hospital
    369 Fulham Road
    London
    SW10 9NH
  • St Thomas' Hospital
    249 Westminster Bridge Road
    London
    SE1 7EH

By taking part in this study, you will be helping the research team check the accuracy of these tests and the effectiveness of UKHSA testing services. This information will help decide how to test for Covid-19 or other infectious diseases in the future, and whether how well tests work is affected by changes in testing approaches or changes to the disease itself.
Taking part may involve doing extra tests which may require some additional time to complete and register. The requirement for extra testing or information collection has been kept to a minimum and will be as close to normal care as possible. The process of collecting the sample can sometimes cause some pain or discomfort depending on the type of sample required.

Dr Edward Blandford
+44 (0)7974 019145
edward.blandford@ukhsa.gov.uk



The study is sponsored by UK Health Security Agency and funded by UK Health Security Agency.



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What will you do next?
Read full details for Trial ID: ISRCTN50943319

Or CPMS 53887

Last updated 20 January 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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