TestGen from the Rusnano FIEP Network Has Developed the First Domestic Snap Test for Coronavirus

26 November 2020

The first domestic snap test for rapid detection of the coronavirus antigen (SARS-CoV-2) in human saliva has been developed by specialists of the TestGen Company from the ULNANOTECH Ulyanovsk nanocenter, which is a part of the investment network of the RUSNANO’s Fund for Infrastructure and Educational Programs. Currently, the necessary documentation is being prepared for clinical trials and obtaining a registration certificate for the medical device.

The developed test detects the presence of the coronavirus immediately after it enters the human body when there are no clinical manifestations of the disease. The analysis does not require special expensive equipment. The test result can be obtained within 15 minutes. The test is suitable for use in areas with high stream of people, such as hospitals, airports, and train stations.

According to one of the main TestGen developers, candidate of biological sciences Denis Viktorov, antigens are proteins that are part of the virus and are recognized by the immune system. There are specific antigens that are present, for example, only in the causative agent of the new coronavirus infection. Unlike the antibody test, which is positive only in the presence of an immune response, that is, in the later stages of the disease, the antigen test determines the presence of the virus itself. This antigen can be identified by special antibodies included in the test strip.

“The test system is based on the use of immunochromatography, which is a faster alternative to the PCR research, and does not require special equipment and complex preanalytical material preparation for the analysis. Accordingly, the snap test can be done not only in the laboratory but also in hospitals, airports, or anywhere else. The new development will allow to get the results in just 15 minutes. This will make it possible to conduct express screening of a large flow of people, to quickly identify those who fall ill even in the absence of any signs and, as a result, to prevent the widespread occurrence of the infection,” says Denis Viktorov.

According to Alexey Grachev, Doctor of Biological Sciences, a specialist in the development and production of antibodies, the difference between the new snap test and its current analogues on the market is its high sensitivity, comparable with PCR, and not only smears from the nasopharynx, but also the saliva of the patient may be used as the material for the analysis.

Upon successful completion of clinical trials and obtaining a registration certificate, TestGen, connecting industrial partners, will be able to quickly organize the serial production of rapid tests on an industrial scale. As the company noted, TestGen’s experience in rapidly scaling up production developments was tested on the CoV-2-Test, a high-precision molecular genetic test for diagnosing the new type of coronavirus. This test system was created and promptly brought to market in spring 2020 and is now actively used in laboratories in Russia and some foreign countries.

Let us remind that coronavirus diagnosis is not the only infectious area of the TestGen R&D research. The company has already developed a test system to detect five urogenital infections with a single PCR test. The second generation of development will include 12 infections. Further plans include diagnosis of human papillomavirus, hepatitis B, C, and D, a panel of respiratory infections relevant to the epidemic season, as well as several others.

Reference

The Fund for Infrastructure and Educational Programs was established in 2010 in accordance with Federal Law No. 211-FZ “On reorganization of the Russian Corporation of Nanotechnologies.” The Fund aims to develop the innovative infrastructure in the sphere of nanotechnology and implement the educational and infrastructure programs already started by RUSNANO.

The supreme collegial management body of the Fund is the Supervisory Board. Under the Fund’s Charter, the competence of the Supervisory Council, in particular, includes the issues of determining the priority directions of the Fund’s activity, as well as its strategy and budget. The Chairman of the Fund’s Executive Board, the collegial management body, is the Chairman of the Board of Management Company RUSNANO LLC Sergey Kulikov.

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The Ulyanovsk nanocenter ULNANOTECH was established in accordance with the program for the creation of nanotechnological centers of JSC RUSNANO. The total investment in the nanocenter will amount to 2.1 bln rubles. The official launch was in August 2013.

The nanocenter specializes in automotive components (composite metal materials, composite polymer materials based on glass and carbon fiber, glass coating, engineering, and prototyping), aviation and space (tooling for metal casting), composite non-ferrous metal castings, prototyping and small-scale production of metal products), and construction (composite materials based on non-metallic minerals, modified concretes, liquid building mixtures and paintwork materials, architectural coated glass, and structural building materials). Andrey Redkin is Director General.

More about the nanocenter — www.ulnanotech.com

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TestGene LLC is a developer and manufacturer of genetic test systems for molecular diagnostics. The main direction of developments is non-invasive diagnostics of fetal condition during pregnancy and diagnostics in oncology. Since 2013, it has been a resident of the Ulyanovsk nanocenter.

For more information about the company, please visit www.testgen.ru