Business
Launch of BioSURE COVID-19 IgG Antibody Self Test
Launch of BioSURE COVID-19 IgG Antibody Self Test.
About this update from Abingdon Health Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 3887J\n Abingdon Health PLC\n 23 August 2021\n \n \n \n \n Abingdon Health plc\n \n \n (\"Abingdon\" or \"the Company\")\n \n \n \n \n \n \n Launch of the BioSURE COVID-19 \n \n \n IgG Antibody Self Test\n \n \n \n \n \n \n Contract manufacturing for CE marked self-test to monitor antibody status \n \n \n \n \n \n \n York, U.K. 23 August 2021: \n \n Abingdon Health plc (AIM: ABDX) \n a leading international developer and manufacturer of high quality and effective rapid tests\n , announces the launch today of the BioSURE COVID-19 IgG Antibody Self Test. In July 2021, Abingdon \n \n \n announced\n \n \n that it had signed an exclusive manufacturing \n agreement with BioSure (UK) Limited (\"BioSure\"), a UK company specialising in the provision of rapid in-vitro diagnostic testing solutions, including self-testing.\n \n \n \n \n \n This new test, for which BioSure is the legal manufacturer, has been CE marked specifically for self-testing. The test uses a fraction of a drop of finger-prick blood (2.5uL) with results in 20 minutes. This allows individuals to know and monitor their own antibody status pre-vaccination, post vaccination and following infection with the SARS-CoV-2 virus. It will be particularly useful as populations worldwide continue to be vaccinated to monitor the effectiveness of an individual's immunity status. This will have utility alongside potential booster vaccinations. Abingdon will be the exclusive worldwide manufacturer for the product.\n \n \n \n \n \n The product has successfully completed technical transfer to manufacture following a pilot production run and is now in full manufacture at Abingdon's expanded manufacturing facilities at York and Doncaster under the Company's ISO13485:2016 quality management system. Technical transfer is the process whereby three or more independent production runs are manufactured, at increasing scale, and validated to illustrate the product is suitable for mass manufacture.\n \n \n \n \n \n Details of the BioSURE COVID-19 IgG Antibody Self Test can be found here: \n \n \n https://biosuretest.com\n \n \n \n \n \n \n \n \n Chris Yates, CEO of Abingdon Health, commented: \n \n \"\n \n We are delighted that BioSure have launched their product and equally happy to be their manufacturing p...