Yorkshire developed Covid-19 test approved for use in North America
A Covid-19 rapid antibody test, developed by York-based medical device manufacturer Abingdon Health, is to be used to detect this illness in the USA.
Abingdon has been notified by the US Food and Drug Administration (FDA) that it will now be able to distribute its UK-RTC AbC19™ Rapid Test in the USA to laboratories and to healthcare workers, for point of care testing.
Distribution of the test will be through CIGA Healthcare, a member of the UK-Rapid Test Consortium. (UK-RTC)
Leigh Thomas, SVP director of global sales of Abingdon Health, said: “Today’s news allows us to immediately make the AbC19™ Rapid Test available to CLIA testing labs in the United States.
“Abingdon Health and our consortium partners in the UK-RTC remain committed to the wide deployment of the AbC19™ Rapid Test and continue to work with regulators both in the UK and internationally.”
It can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers. It uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need to send a sample to a lab.
The test detects IgG antibodies to the SARS-CoV-2 virus, specifically those IgG antibodies which react to the spike protein of the virus.
These are the type of antibodies the body produces to tackle and neutralise the virus.