Source : Medtech Insight
A rapid test for SARS-CoV-2 antibodies, developed by UK company Abingdon Health Ltd., has been CE-marked for professional use in the UK and EU. The company, which is part of the UK-Rapid Test Consortium (UK-RTC), also plans to gain approval for a home-use test in the coming months.
The AbC-19 Rapid Test uses fingerstick blood and shows results in around 20 minutes on a simple lateral flow device. It detects IgG antibodies that react to the spike protein of the virus; although it’s not yet clear whether these, or other antibody types, have any neutralizing effect on the virus. ("Antibody Testing During And After The Pandemic Not All Tests Are Created Equal" "Medtech Insight" )
The AbC-19 Rapid Test will be mass-produced, and tests will be rolled out from the end of August, with output expected to reach 500,000 tests per month from October, and one million per month from next year. The test can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers.
Rapid testing for SARS-CoV-2 antibodies has been plagued by numerous cases of inaccurate products. In March, the UK government ordered 3.5 million home test kits to identify people who have antibodies to the SARS-CoV-2 virus. However, the tests proved too inaccurate for use. ("UK Govt Buys 35M 15Minute COVID19 Antibody Home Tests From Mystery Manufacturer" "Medtech Insight" )
The AbC-19 Rapid Test has demonstrated that fingerstick blood can provide results with high levels of accuracy. In samples taken from multiple production scale batches, the test was 99.4% accurate, making it one of the most accurate rapid antibody tests for SARS-CoV-2 currently available. Testing was performed at Ulster University and Abingdon Health. In an evaluation of three validation batches, the test showed a sensitivity of 98.03% and specificity of 99.56%. 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 COVID-19 or tested positive for COVID-19 by PCR and tested positive by a commercially available antibody ELISA test (Euroimmun Anti-SARS-CoV-2 ELISA (IgG)). The tests will go through further independent evaluation over the coming weeks.
The UK-RTC comprises Abingdon Health, the University of Oxford, Omega Diagnostics Ltd., BBI Solutions and CIGA Healthcare Ltd . Abingdon Health, the consortium’s lead company, fast-tracked development and completed CE marking in 14 weeks, a process that would normally take 10 months or more.
Each member of the UK-RTC will manufacture the test and has the supplies to manufacture an initial 10 million tests.
The AbC-19 Rapid Test will also undergo ease-of-use trials to allow the UK’s 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.
The UK government currently provides laboratory-based tests in the first phase of its antibody testing program, to National Health Service and care staff. Clinicians are also able to request the tests for patients in both hospital and social care settings if they think it’s appropriate. These tests require blood samples to be taken by trained professionals.
Since then, the government has been working in partnership with the private sector to develop rapid tests, which will ultimately be suitable for use at home and without medical supervision.
By Phil Greenfield