Express-IgG/IgM SARS-CoV-2-IHA

Main article: Antibodies to COVID-19 coronavirus

2021: EU Certification

Rapid Bio, a resident of the Skolkovo Foundation, received a European certificate CE mark - registration number DE/CA09/0170/R26/IVD/001. The COVID-19 express antigen test was the first Russian test registered in the European Union.

In the near future, the company plans to deliver to the European Union, where the market volume for June 2021 is hundreds of millions of tests per month. Negotiations are underway with distributors from France, Italy, Latvia, Bulgaria and Finland. Previously, the company intends to export several million tests monthly. The plans include scaling the coverage area to Africa, Latin America and Southeast Asia. The presence of CE mark allows you to speed up the process of obtaining registration in the markets of these countries. Applications have already been submitted.

Rapid Bio express test allows you to determine the presence of the virus with a nasopharyngeal smear in less than 10 minutes. The SARS-COV-2 virus antigen is determined in the sample, which is a kind of analogue of the PCR test, but does not require additional equipment and laboratory studies.

Rapid Bio's products have already proved their effectiveness and demand in Russia, and entering the EU is another step towards neutralizing the global threat. The huge capacity of the European market - it is measured in hundreds of millions of tests per month - will realize the impressive potential of Russian express test developers from Skolkovo, " said Arkady Dvorkovich, Chairman of the Skolkovo Foundation.

We are very glad that now high-tech medical products of Russian manufacture will become available in the European Union. This is an opportunity to contribute to the fight against the global pandemic and promote the results of the scientific work of Russian scientists. Our test is one of the most sensitive and quality in the world market. We thank for the support of the Skolkovo Foundation, the Government of the Republic of Buryatia, the Bortnik Foundation and everyone who helped in the development and promotion of tests on the world market, noted Anzhey Zhimbiev, CEO of Rapid Bio.

2020

Start of deliveries abroad

In early November 2020, Rapid Bio announced the delivery of its express tests for COVID-19 coronavirus abroad. First, Express-IgG/IgM SARS-CoV-2-IHA will go to the CIS countries, and then to Germany.

According to Skolkovo, whose resident is Rapid Bio, the company is already ready to produce more than 100 thousand tests per month, and by the end of 2020 it is planned to ensure the production of up to 1 million products.

The main source of funding for the company was the Boomstarter crowdfunding platform, where Rapid Bio raised 2.5 million rubles over the week. The test was developed with the support of 570 sponsors in Russia and beyond, according to the Rapid Bio website.

Russian test for coronavirus from Rapid Bio sent for export to the CIS and Germany

We started developing, but our money was very limited because we are a startup. We wrote to the Ministry of Health and other Russian departments, as well as to large companies and investors with a request for help, "said Anzhey Zhimbiev, founder of Rapid Bio.

The test is able to detect antibodies IgG and IgM to SARS-COV-2 in serum, plasma or whole blood in 10 minutes with an accuracy of 96%. The cost of a set of 20 copies of the test is 19 thousand rubles, according to the company's website on November 6, 2020.

By decision of the operational headquarters to combat the spread of coronavirus infection, Buryatia (Anzhey Zhimbiev comes from there) will purchase 50 thousand express tests from the company. For rapid diagnosis in hospitals, 20 thousand tests will be acquired that can determine the protein antigenic structures of the virus in biological material using munochromatography methods. For these purposes, the republican budget allocated more than 30 million rubles. Another 30 thousand rapid tests for antibodies are planned to be purchased for use in a mass study on COVID-19. 12.3 million rubles were allocated for their purchase.^[1]

Registration with Roszdravnadzor

Rapid Bio, a resident of the Skolkovo Foundation Biomedical Technology Cluster, received a Roszdravnadzor registration certificate for an express test to detect antibodies to coronavirus SARS-CoV-2. This was announced by the Skolkovo Foundation on June 19, 2020.

With the help of an express blood drop test, even at home, you can determine the response of the immune system to the penetration of the virus into the body.

Rapid Bio began developing a test for SARS-CoV-2 in February 2020. To buy expensive reagents, fundraising was launched on a crowdfunding platform. The necessary 2 million rubles were collected in less than a week.

In turn, the Skolkovo Foundation took over customs support for the delivery of reagents from China, the USA and Europe, ensuring access of Rapid Bio specialists to blood samples of patients with a confirmed diagnosis, as well as communication with government authorities to speed up the registration of the express test as a medical product.

This project has become a big challenge for our young team of biotechnologists. We worked in our laboratory at the Skolkovo Technopark for 24 hours, 7 days a week for 3 months, having completed the development of the test system and its tests in a short time. We thank Technopark and the Skolkovo Foundation for their assistance in conducting clinical trials, logistics and customs clearance of reagents in extreme pandemic conditions, as well as for information support. We are also grateful to the Innovation Promotion Fund and the Industrial Development Fund of the Republic of Buryatia for financial support for the organization of production. There is even more work ahead of us - directly launching production and continuing development in the field of express diagnostics.

Thanks to the synergistic work of the Skolkovo Foundation and Rapid Bio, an express test for the diagnosis of COVID-19 was registered. Test system is based on detection of antibodies of classes IgM and IgG by immunochromatographic analysis of biomaterial taken from patient. Capillary blood ('blood from the finger') can be used to perform the test, which in turn allows for examination, both at the patient's bed and at home. The analysis time is 10-15 minutes and the diagnostic sensitivity is 96%. The emergence of this test in the Russian market will allow a faster and more effective fight against the spread of infection, providing the structures of health care and ordinary citizens with the necessary volume of test systems during the pandemic.

The production of rapid tests to detect antibodies to coronavirus SARS-CoV-2 will be launched on the basis of the DRD company, which is also a resident of the Skolkovo Foundation.

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