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The Saliva Clinical Trials

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    In my quest to find the mythical saliva-based clinical trials, I came upon these on the NHIR website.
    .
    These are the most recently updated testing-related trials. Take note of the lengthy recruitment phases.

    Evaluating home antibody test kits for the detection of coronavirus (COVID-19) antibodies
    Recruitment: Jun 2020 - Jun 2021
    Last updated: 25 Mar 2021

    Non Inferiority Trial for Detection of nCOVID-19 Through Analysis of Exhaled Breath Aerosols
    Recruiting: July 2020 - December 2020
    Last updated: 29 Mar 2021

    Covid-19 Breath Test
    Recruitment: Jun 2020 - Jan 2021
    Last updated: 28 Jan 2021

    A Study to Evaluate Rapid Throughput Screening for Human COVID-19 Infection
    Recruitment: Dec 2020 - Jul 2021
    Last updated: 25 Jan 2021



    I found the following one the most interesting:

    Rapid community testing for COVID-19
    Recruitment: Oct 2020 - Oct 2021
    Last updated: 7 Apr 2021

    This study is expected to run from April 2020 to June 2022.

    A wall of text for the patient. This is a study we definitely want to be in.

    The NHS urgently needs quick, accurate rapid diagnostic tests to diagnose people with coronavirus or to confirm that people do not have the infection. Point-of-care Tests (POCTs) can be used in community settings where there is no easy access to a specialist laboratory. They provide quick results that allow people to get immediate advice about self-isolation and treatment, potentially blocking further spread of infection in the community. Companies are quickly developing new rapid diagnostic tests, but we do not know how well they work. Some tests give a result like a pregnancy test by using a drop of blood from a finger prick. Others use saliva, or a swab to collect a sample from the nose or throat.

    Companies check tests work in their laboratories, but usually tests do not work as well when used in the field with real patients. Accurate rapid diagnostic tests are important so that people are not falsely reassured when they are infected, and are not wrongly diagnosed when they are not really infected.

    The researchers manage a national surveillance system with a network of community settings including GP practices from all over England that report directly to the Department of Health and Social Care about a wide range of infections. These GP practices have been testing for coronavirus since January 2020 with samples sent for laboratory tests. In this study, practices in the network will quickly compare new POCTs for coronavirus with laboratory tests to see how good the new tests are in a coordinated and efficient way.
    National COVID-19 Test centres may also support the research project.

    There are currently no rapid diagnostic tests that have been evaluated as fit-for-purpose in NHS primary care that aim to identify whether adults are currently, or have been, infected by COVID-19. Accurate diagnosis of infection, identification of immunity and monitoring the clinical progression of infection are of paramount importance to our response, and for all of these diagnostics are central. Widespread population testing has proven difficult in western countries and has been limited by test availability, diagnostic test sensitivity, human resources and long turnaround times (up to 72 hours). This has limited our ability to control the spread of infection and to develop effective clinical pathways to enable early social isolation of infected patients, early treatment for those most at risk and early return to work for those with resolved infection and potential immunity. Point-of-care tests (POCTs) can be used in the community where there is no easy access to a specialist laboratory, in locations such as NHS general practices. POCTs provide quick results that allow people to get immediate advice about self-isolation and treatment, potentially blocking further spread of infection in the community. In-context evaluation of POCTs in the community is important as test accuracy can vary based on the prevalence of disease in the population tested. The severity of the COVID-19 disease in the community is much lower than in hospital patients. Symptomatic acutely unwell hospitalised patient are likely to have higher viral loads that are easier to detect, and may be undergoing invasive procedures to collect samples from the lower respiratory tract, that have a higher yield. Testing only severe patients introduces spectrum bias, and biases the results to overestimate test performance. It is important to diagnose hospital patients, but from a public health point of view the most concerning patients are ambulatory outpatients, who may spread the virus much further in the community if falsely reassured. Evaluations of COVID-19 POCTs are therefore required in each clinical setting. Community-based POCTs may lead to additional public health impacts such as reducing onward household transmission of COVID-19, improving surveillance of NHS and social care staff, accurate prevalence estimates, and understanding of COVID-19 transmission dynamics in the population. This study will provide the community testbed to the COVID-19 National Diagnostic Research and Evaluation Platform (CONDOR). Its platform design will allow for both flexibility in which POCTs are evaluated and for changes in PHE choice of reference standard.

    Partial: https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=6882&location=&distance=
    Full: https://www.isrctn.com/ISRCTN14226970
    Protocol V5 (Mar 18th 2021): https://www.isrctn.com/editorial/retrieveFile/aeee63ba-c784-4198-9d39-6d8c03899ac4/38533


    Conclusion: There doesn't appear to be an ADO-specific test in the UK. I cannot find one in India either (last checked Friday).

    As you can see by the recruitment phases, they take a rather long time to even get off the ground. The trial I referenced above looks like one evaluating various tests as they come to market, hence the 2+ year duration. If anything, this is where ADO's test would be evaluated. However, as of the 18th of March, only 3 tests were being tested (screenshot below). Until you see 'EuGeni' in there, put down your party poppers. I'd love to be proven wrong, so I put forth a challenge to the euphoria-crowd to find the saliva trials. From where I sit, it doesn't look like much is happening yet, unless we are being evaluated there and will be featured in the next protocol update. Of course, we are still good to go with nasal-swabs, so I await to see what kind of results that produces in the near-term.

    The positive thing is that 2/3 currently evaluated tests are lateral-flow antigen based, with one using a reader. So we definitely look like a good candidate for the race.

    https://hotcopper.com.au/data/attachments/3105/3105465-8a5285e739cc1b099b726f82939e5b86.jpg


    Further resources:
    EU: https://www.clinicaltrialsregister.eu/ctr-search/search?query=covid-19
    India: http://ctri.nic.in/Clinicaltrials/advancesearchmain.php

 
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