The Federal Medical and Biological Agency (FMBA) has completed clinical and technical tests of Izascrin-8, a device for detecting coronavirus, and it is planned to submit documents for its registration soon, as Veronika Skvortsova, the head of the agency, reported.
“This device has been validated in a large number of clinics. … Now the validation has been completed, and both clinical and technical tests have been done. We are ready to submit this device for medical registration,” TASS quotes Skvortsova as saying.
It is noted that Izascrin-8 portable analyzer identifies DNA/RNA of pathogens of infectious diseases, including COVID-19, in biological material (pharyngeal smear) in 25-30 minutes. The time of a complete analysis to identify COVID-19 RNA is less than 30 minutes, while the time of extraction of RNA from the sample is about 10 minutes, and reverse transcription and amplification with optical registration of the process in real time takes 17.5 minutes.
The device is designed for simultaneous processing of two samples with controls to obtain a validated test result. Izascrin-8 is intended for mobile use in laboratories and testing stations, as well as by ambulance crews and sports medicine doctors.
