Company “Testgen” from Ulyanovsk nanocenter ULNANOTECH received may 15, 2020 registration certificate and started mass production of its own genetic test to detect coronavirus infection COVID-19. The new test system indicates the presence or absence of RNA of SARS-CoV-2 in the early stages and with high accuracy of more than 96%, the company said.
The basis of the test CoV-2-Test based on the polymerase chain reaction in “real time” reverse transcription (RT-PCR), which is recommended by the world health organization as the most accurate and reliable method for the diagnosis of viral infection. The TES system was developed by specialists of “Testgen” about a month according to the order of “Genext” (a joint project ULNANOTECH and “Testgen”). First batch ready for sending to regions of Russia.
The new test system has successfully passed clinical trials in FGBUZ “Head center of hygiene and epidemiology of the Federal medical-biological Agency of Russia” (Moscow) and showed the test’s accuracy 96-100% with the right analysis at all stages, the sensitivity is 500 copies of virus in 1 ml of biomaterial. The sample for analysis is biological material taken from the mucous membrane, naso – or oropharynx of the patient, or sputum from the lungs. The test result can be obtain in two hours.
“The company’s production capacity and the presence of certification of GOST ISO 13485 allow us to produce at the initial stage to 50 thousand tests a day, and in the long term – to 2 million in a month. Company “Testgen” will render any assistance in the delivery of test systems in regions of Russia”, – assured General Director, candidate of medical Sciences Andrey Toropovskiy. According to him, the devices for performing these analyses include all the PCR laboratory. So testing can be carried out not only in specialized centers. “To enter the foreign market we prepare to receive the test-system of the European CE-certificate”, – said Andrei Toropovskiy.