Company “Testgen” received the European certificate of conformity CE for a set of reagents for the qualitative detection of RNA of coronavirus (SARS-CoV-2) by RT-PCR technique in real time “CoV-2-Test.”The existence of this document confirms compliance of a medical device company meet the requirements of the European Union.
Earlier, on 15 may, the company received a registration certificate of Roszdravnadzor and started mass production test systems. Test to determine the presence of coronavirus in a sample taken from the mucous membrane, naso – or oropharynx, with an accuracy of more than 96% in the early stages of infection.
“Our production capacities allow to produce up to 50 thousand tests a day, and in the future – up to two million per month. I am confident that our company will contribute to the fight against the pandemic, offering the world community, along with existing analogues, high-quality precision diagnostic set,” – said General Director of “Testgen” Andrew Toropovskiy.