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Roszdravnadzor has approved the production of ultra-precise test for coronavirus

Росздравнадзор одобрил производство сверхточного теста на коронавирус

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Company “Testgen” Ulyanovsk nanocenter Ulnanotech received registration of Roszdravnadzor and started mass production of its own ultra-precise test COVID-19.

The results of the study can be read in two hours is added to the report of the Fund for infrastructure and educational programs “RUSNANO”, which includes “Testgen”.

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“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 future — up to two million per month. Company “Testgen” will render any assistance in the delivery of test systems in the regions of Russia. To exit the foreign market we prepare to receive the test-system of the European CE-certificate”, — said General Director of “Testgen”, candidate of medical Sciences Andrey Toropovskiy.

The specialists of “Testgen” developed the test-system “CoV-2-Test” about a month according to the order of “Genext”. It shows the presence or absence of RNA of SARS-CoV-2 in the early stages and with high accuracy over 96%.

The test is based on polymerase chain reaction 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.

When developing a test system among other things, the recommendations of Management on sanitary inspection behind quality of foodstuff and medicines USA (FDA), the report says.

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The test can detect the disease in the incubation period and in the early stages.

The new system has successfully passed clinical trials in FGBUZ “Head center of hygiene and epidemiology of the Federal medical-biological Agency of Russia” and showed the accuracy of 96-100% in the analysis at all stages, the sensitivity is 500 copies of virus in a milliliter of biological material.

Recent data on the situation of COVID-19 in Russia and the world presented on the portal stopmanager.of the Russian Federation.

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