The ISO 13485:2016 MDSAP certified test is said to be a portable, user-friendly test which demonstrated 100% accuracy in clinical studies
The iStatis COVID-19 Antigen Home Test Kit Components. (Credit: GlobeNewswire, Inc./bioLytical Laboratories Inc.)
Canada-based diagnostic devices manufacturer bioLytical Laboratories has received CE Mark for its iStatis Covid-19 Antigen Home Test, clearing the path for sale in the European market.
The test, built on the company’s testing platform INSTI, can be performed with easy-to-understand results without the need for additional readers or machinery.
It is ISO 13485:2016 MDSAP certified, ensuring reliable access to testing for everyone along with features like user-friendly and 100% accuracy in clinical studies, said the company.
bioLytical CEO Rob Mackie said: “We are excited to announce the addition of iStatis in Europe with our new Covid-19 rapid antigen home test.
“With our new iStatis platform, we can expand our reach and increase access to testing across Europe. With the unpredictable nature of the pandemic, we are proud to offer Europeans a reliable and trusted test that they can take in the comfort and privacy of their own homes.”
The iStatis Covid-19 Antigen Home Test will aid in infection detection by giving Europeans the option for a simple test at home.
The iStatis test kits will be manufactured at bioLytical’s ISO 13485:2016 MDSAP-certified facility in Richmond, British Columbia. The firm is committed to the easy availability of test kits across Europe.
INSTI and iStatis are known for their real-time results that aid health professionals, patients and organisations in the handling of some severe healthcare challenges, said bioLytical.
Earlier this month, bioLytical Laboratories secured Health Canada’s approval for its iStatis Covid-19 antigen test.