LONDON: British ministers are making plans to distribute millions of free coronavirus antibody tests after a version backed by the UK government passed its first major trials, the Daily Telegraph newspaper reported on Friday.
The fingerprick tests, which can tell within 20 minutes if a person has ever been exposed to the coronavirus, were found to be 98.6% accurate in secret human trials held in June, the newspaper reported.
It added the test was developed by the UK Rapid Test Consortium (UK-RTC), a partnership between Oxford University and leading UK diagnostics firms.
Britain’s only antibody tests approved thus far have involved blood samples being sent to laboratories for analysis, which can take days, The Telegraph said.
Anticipating a regulatory approval in the coming weeks, tens of thousands of prototypes have already been manufactured in factories across the United Kingdom, the report added.
Ministers are hoping that the AbC-19 lateral flow test will be available for use in a mass screening programme before the end of the year, the newspaper reported.
“It was found to be 98.6% accurate, and that’s very good news,” Chris Hand, the leader of the UK-RTC, was quoted as saying by The Telegraph.
“We’re now scaling up with our partners to produce hundreds of thousands of doses every month”, Hand said, adding the government’s health department is in talks with UK-RTC over buying millions of tests before the year ends.
The tests are likely to be free and would be ordered online instead of being sold in supermarkets, according to plans cited by the newspaper.
“While these tests will help us better understand how coronavirus is spreading across the country, we do not yet know whether antibodies indicate immunity from reinfection or transmission,” a Department of Health and Social Care spokesman was quoted as telling the newspaper.
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Design freeze for AbC-19TM lateral flow test for IgG antibodies to the SARS-COV-2 virus
Posted: June 29, 2020
Company News
Abingdon Health is delighted to announce the UK-RTC has reached design freeze for the AbC-19TM lateral flow test for IgG antibodies to the SARS-COV-2 virus (COVID-19). Achievement of this major milestone led by Abingdon Health’s R&D department means the test meets the required performance characteristics and the production specifications of the assay have now been set. The next stage will see the scale-up of processes in July in readiness for manufacture.
With regards to the test performance, an evaluation of pilot batch products showed a test sensitivity of 100% (95% confidence interval 92.6% to 100%) and specificity of 98.4% (95% confidence interval 95.4% to 99.7%). These figures have been calculated following analysis of a total of 186 samples taken from individuals pre-September 2019 (negatives) and 48 patients who had symptoms of COVID-19, a positive PCR result for the virus or both. Results are from analyses performed at the University of Ulster and Abingdon Health laboratories and follow an earlier analysis at Imperial College, London of 188 positive samples using pre-design freeze devices which showed a 95.7% sensitivity.
If the population is assumed to have a 10% incidence of COVID-19, the AbC-19 pilot batch test shows a 98.6% accuracy.
Additional independent testing of positive and negative samples along with other analytical studies will allow CE marking of the product by Abingdon Health. Work is continuing in parallel with the regulatory authorities to ensure approval of the test as quickly as possible.
This is a major step forward in an extremely complex project that has been completed in a very short time period compared to a normal test development programme. The UK-RTC has been committed to delivering this vital test to the UK public, to assist in the management of COVID-19 infections and aid further understanding of the disease.
Abingdon Health’s CEO, Chris Yates, commented:
“This has been a tremendous company-wide effort at Abingdon Health working with our partners at UK-RTC. Our R&D team have led the process working long hours to achieve this magnificent milestone. I am very proud of their commitment and the team-work across all functions of the company. We will now move the product through to production in July and liaise with our consortium partners for roll out of manufacturing across the UK-RTC.”
About Abingdon Health
Abingdon Health is a technology-enabled lateral flow diagnostics company providing innovative rapid testing solutions to a multi-industry, global client base. Located across 3 UK sites, Abingdon Health provides specialist assay development and Smartphone reader services alongside Europe’s largest lateral flow test manufacturing capacity. By combining a multi-disciplinary approach with precision automation Abingdon Health assures product consistency and security of supply for the most complex of assays and markets. Abingdon Health takes projects from initial concept through scale-up and into high-volume manufacturing in addition to accommodating clients looking to transfer their rapid test from third-party developers or manufacturers.
Abingdon Health is headquartered in York, United Kingdom. Visit www.abingdonhealth.com.
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