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15th September 2020  Author: Paul Carton

UK Begin At-Home COVID-19 Antibody Testing Programme


The UK’s National Health Service (NHS) has a severe shortage of COVID-19 tests, with symptomatic people told to travel hundreds of miles to test centres.

However, the UK-Rapid Test Consortium (UK-RTC), which comprises of diagnostic manufacturers and universities, will soon deliver lateral-flow antibody tests to people living in the UK that cannot make it to a test site i.e. due to long-distance travel which requires the use of public transport.

The UK Rapid Test Consortium (UK-RTC) is a collaboration between the University of Oxford, Abingdon Health, Omega Diagnostics, BBI Solutions and CIGA Healthcare.

The consortium is working with NHSX – the technology, digital and data service of the NHS - to develop a test specific app and digital service that will facilitate the use and reading of the test device. This will have the ability to integrate with NHS systems and update records.

The AbC-19TM Rapid Test detects IgG antibodies, is designed for at-home-testing, and provides a result in 20 minutes.

The test is already CE-marked and recently underwent a trial, involving 2000 participants at Ulster University to see if people from the ages of 8 to 80 could perform the test by themselves and correctly interpret the results. The results from this trial will now allow the Medical and Healthcare products Regulatory Agency (MHRA) to provide necessary approvals for its use by the general public

Those who tested positive for IgG in the trial, are given the opportunity to be assessed for up to one year, to see how long the antibodies are present.

The NHS is now asking the general public, who fulfil the criteria needed for an at-home-antibody test, to sign up now.

Validaton: 

In an evaluation of three validation batches, the test showed a sensitivity of 98.03% (95% confidence interval 95.03% to 99.46%) and specificity of 99.56% (95% confidence interval 98.40% to 99.95%).

These figures have been calculated following analysis of a total of 450 samples taken from individuals pre-September 2019 (negatives) and 203 patients who had symptoms of COVID19 or tested positive for COVID-19 PCR.  and tested positive by a commercially available Antibody ELISA test (EuroImmunTM).

Results are from analyses performed at the Ulster University and Abingdon Health laboratories.

Demonstration:


    

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Date Published: 15th September 2020

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