Russia Approved A Test System That Detects Coronavirus With An Accuracy Of 96%

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Russia Approved A Test System That Detects Coronavirus With An Accuracy Of 96%
Russia Approved A Test System That Detects Coronavirus With An Accuracy Of 96%
Video: Russia Approved A Test System That Detects Coronavirus With An Accuracy Of 96%
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Russia approved a test system that detects coronavirus with an accuracy of 96%

Tests show the presence or absence of SARS-CoV-2 RNA at the earliest stages, the results can be found in just two hours.

Russia approved a test system that detects coronavirus with an accuracy of 96%
Russia approved a test system that detects coronavirus with an accuracy of 96%

Photo: ulnanotech.com

The technology was developed by the TestGen company of the Ulnanotech Ulyanovsk nanocenter, which is part of the investment network of the Fund for Infrastructure and Educational Programs of the Rusnano Group (FIOP). The new test system demonstrated an accuracy of 96-100% if the analysis was carried out correctly at all its stages, the sensitivity was from 500 copies of the virus in 1 ml of biomaterial.

According to the FIOP press service, on May 15, the company received registration from Roszdravnadzor and launched mass production. The first batch of ultra-precise test systems is already ready to be sent to the regions.

“The test“CoV-2-Test”is based on the method of polymerase chain reaction in“real time”with reverse transcription (RT-PCR), which is recommended by the World Health Organization as the most accurate and reliable method for diagnosing a viral infection. When developing the test system, the recommendations of the FDA (Food and Drug Administration - US Food and Drug Administration) were taken into account,”the FIOP said in a statement.

A sample for analysis is a biomaterial taken from the mucous membrane of the patient's nasopharynx or oropharynx, or sputum from the lungs. Thanks to the use of modern highly productive enzymes, the test detects even a very small amount of genetic material (RNA) of the virus in human biological material. This helps to identify the disease in the incubation period and at the earliest stages. A highly accurate test result can be obtained in two hours.

"The RT-PCR method is best suited for detecting the SARS-CoV-2 coronavirus, since it is highly sensitive and allows detecting even single copies of the virus RNA in a biological sample," says Denis, Head of the TestGen Scientific and Technological Development Laboratory, Ph.D. Viktorov. In addition, this method makes it possible to make the test highly specific, since the flexibility at the development stage allows you to select unique nucleotide sequences found only in this virus.

“The production capacity of the company and the availability of GOST ISO 13485 certification allow us to produce at the initial stage up to 50 thousand tests per day, and in the future - up to 2 million per month. The TestGen company will provide any assistance in the supply of test systems to the regions of Russia,”said Andrey Toropovsky, General Director, Candidate of Medical Sciences. According to him, all PCR laboratories are equipped with devices for performing such analyzes. Therefore, testing can be carried out not only in specialized centers.

Toropovsky also added that the company is ready to enter the foreign market and is now in the process of obtaining a European CE-certificate (Conformité Européenne - "European compliance").

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