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A rapid finger-prick test for COVID-19 antibodies — manufactured by a government-backed group — could be licensed for home use “in the coming months”, says the manufacturer.
The AbC-19 Rapid Test has received its CE mark for use by healthcare professionals, listing pharmacists as potential users, said the manufacturer Abingdon Health in a statement on 30 July 2020.
The test will now undergo further trials and regulators will decide if it can be cleared for home use; however, it is unclear whether pharmacies will be then allowed to sell it or not.
Abingdon Health is part of the UK Rapid Test Consortium (UK-RTC), which was announced by the Department of Health and Social Care in April 2020 as part of a drive to deliver a “homegrown” antibody test after it was discovered that millions of tests imported from China did not work. UK-RTC also includes the University of Oxford, BBI Solutions, CIGA Healthcare and Omega Diagnostics.
The manufacturer claims the AbC-19 test has a sensitivity of 98% and specificity of 99.6% for COVID-19 antibodies, and shows results in 20 minutes.
Abingdon Health said it expects to begin manufacturing in August 2020, producing 500,000 antibody tests per month from October 2020 and 1 million per month from January 2021. It added that “the UK-RTC can manufacture 10 million tests within a six-month period”.
Chris Yates, chief executive officer of Abingdon Health, said the test was “a breakthrough for UK life sciences”. He added: “Our research and development teams have been working two shifts a day, seven days a week, to develop the test. We have deployed nearly 15 times the number of people that would be on a typical project to deliver this test as quickly as possible.”
The test, which detects immunoglobulin G antibodies — the most common type of antibody to be found in the blood — is expected to undergo further evaluation, including “ease of use trials with the general public”.
The company said this would allow the Medicines and Healthcare products Regulatory Agency (MHRA) “to provide the necessary approvals for it to be used by the public as a home test which is expected in the coming months”.
“These trials will be performed in conjunction with Ulster University, using around 2,000 volunteers,” it added.
Previously, the General Pharmaceutical Council (GPhC) had told pharmacists who were providing point-of-care antibody tests to stop, after The Pharmaceutical Journal revealed that 470 community pharmacists were offering a rapid finger-prick antibody test made by the manufacturer Pharmadoctor.
The GPhC had said providing such tests was against advice issued by Public Health England (PHE).
PHE said at the time that it had no intention of changing its advice that there is not enough evidence to recommend the general public use these tests. It has not yet responded to requests for comment from The Pharmaceutical Journal on whether it plans to change its advice for the AbC-19 Rapid Test.
Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies, said: “The tests are legal for use across the EU and approved for the UK by the MHRA. Our members are disappointed that they cannot offer these tests as a professional service through community pharmacy.
”Pharmacists are dedicated healthcare professionals who take their role as counsellors for the public’s healthcare very seriously and are capable of managing the consultation needed before and after testing.”
The government said in May 2020, in its COVID-19 testing strategy, that once laboratory tests were approved, testing could potentially be done at home with a finger prick, delivering results “maybe in as little as twenty minutes”.
In June 2020, the government said it was in the process of recruiting 2,500 volunteers from across England to examine “the potential of home-based antibody tests” using finger-prick blood.