Skolkovo coronavirus test
A new rapid test for COVID-19 from a Skolkovo resident is registered in the Russian Federation
Rapid Bio, a resident of the biomedical technologies cluster of the Skolkovo Foundation, has received a registration certificate from Roszdravnadzor for an express test to detect antibodies to the SARS-CoV-2 coronavirus. The time of the analysis by a drop of blood is 10-15 minutes, and the diagnostic sensitivity is 96%.
With the help of an express test, a drop of blood can be used at home to determine the response of the immune system to the penetration of the virus into the body.
Rapid Bio started developing a test for SARS-CoV-2 in February. "Even then we had an understanding that the situation was threatening to escalate into an extraordinary one," he said later in an interview Sk.ru the general director of the company is Anjey Zhimbiev. – Probably, we could have moved faster, but, unfortunately, at that time the reagents that have now appeared on sale were not available. I wrote letters to the Ministry of Health, Rospotrebnadzor and Roszdravnadzor, informed them that we were planning such a development, and asked for support in accessing the biomaterial. At the same time, we began to actively study analytics on coronavirus."
To buy expensive reagents, a fundraising campaign was launched on a crowdfunding platform. The necessary 2 million rubles were collected in less than a week.
In turn, the Skolkovo Foundation undertook 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 accelerate the registration of an express test as a medical device.
"This project has become a big challenge for our young team of biotechnologists," continues Anjey Zhimbiev. – We worked in our laboratory at the Skolkovo Technopark 24 hours, 7 days a week for 3 months, completing the development of the test system and its tests in record time. We thank the Technopark and the Skolkovo Foundation for their assistance in conducting clinical trials, logistics and customs clearance of reagents in the extreme conditions of the pandemic, 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 high-tech production. There is even more work ahead of us – the direct launch of production and the continuation of developments in the field of express diagnostics."
The test system is based on the detection of IgM and IgG antibodies by immunochromatographic analysis of biomaterial taken from a patient, explains Natalia Polushkina, Vice President of the Foundation, Executive Director of the biomedical technologies cluster. To perform the test, capillary blood can be used, i.e., as they say, blood from a finger, which in turn allows the study to be carried out both at the patient's bedside in the clinic and at home. At the same time, the analysis time is 10-15 minutes, and the diagnostic sensitivity is 96%.
"The appearance of a new test on the Russian market, which is the result of the synergistic work of the Skolkovo Foundation and Rapid Bio, will allow us to fight the spread of infection faster and more effectively, providing healthcare structures and ordinary citizens with the necessary volume of test systems during a pandemic," Natalia Polushkina believes.
The production of rapid tests for the detection of antibodies to the SARS-CoV-2 coronavirus will be deployed on the basis of the resident of the Skolkovo Foundation of the company "DRD".
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