The first and so far the most accurate
How Ulyanovsk created the simplest and most accurate COVID test back in April
Nikolai Maslov, iPhones.ru
The coronavirus turned the world upside down: for the first time in this century, humanity temporarily forgot about the "stars" and switched focus to true heroes – scientists and doctors.
Never before have ordinary people and the media paid so much attention to the activities of medical institutions.
But most news articles about the achievements of scientists still cover the activities of foreign scientific centers. But even Russian scientists are capable of important discoveries.
Moreover, not all breakthrough technologies are created in Moscow. Take the same "crown": the first serial high-precision complex for testing was created not in the capital, but in my native Ulyanovsk.
Why the test system development center appeared in Ulyanovsk
Ulyanovsk turned out to be a hostage of technological progress. At first, a small provincial town, due to the evacuation of a number of enterprises in the western part of Russia, began to produce cartridges and cars.
On the basis of the evacuated factories, large industrial enterprises arose, the development of which required the development of a research and engineering base.
Composites, unique electronic and technical solutions, the first Soviet computers, naval defense systems and the largest production aircraft in the world were created in my city.
After perestroika in Ulyanovsk has preserved squares, machines and personnel; scientific schools and technical dynasties.
At the beginning of 2010, this base became in demand by the Ulyanovsk free economic zone, for which unique residents were immediately found: neighbors prefer to trade and build, and Ulyanovsk – to develop and patent.
For their effective activity, the Ulyanovsk nanocenter ULNANOTECH was formed with the participation of the Government of the Ulyanovsk region, RUSNANO and local universities.
Many high-tech startups have gathered here, many of which have been working for almost 10 years. Today I will tell you about the loudest and most relevant, in view of the information agenda around COVID.
How are medical startups created in the "outback"?
One of the first residents of the Ulyanovsk nanocenter ULNANOTECH of the investment network of the FIOP of the RUSNANO Group was a startup for the production of genetic tests "TestGen", the winner of the "Start" program and the "Development-NTI" competition of the Innovation Promotion Fund.
The history of the laboratory dates back to 2011, when the director of TestGen, Andrey Toropovsky, created Gen-Technology LLC in Samara to develop an innovative genetic method for determining the Rh conflict of a mother and an unborn child.
In 2012, the company moved to Dimitrovgrad, where the Dimitrovgrad Nuclear Innovation Cluster was created on the basis of the Nuclear Medicine Center.
This is where the modern "TestGen" appeared in a minimal composition with its own methodology. And already at the end of 2013, the first part of the company moved to the Ulyanovsk nanocenter.
ULNANOTECH financed the developments – not only the current ones, but also the subsequent ones, which the TestGen team began to implement already on the Ulyanovsk land, where the creators of the company from Samara and Moscow have found a number of additional specialists.
Under the banner of the nanocenter, the team has created several startups, expanding the scope of work and increasing the number of employees.
"TestGen" became a production "site", GENEXT took over the development of methods, some of the ideas were implemented under the signs of LLC "Jinext" and LLC "NucleoGen".
"TestGen has assembled one of the strongest teams in the country in the field of molecular genetics," said Anatoly Chubais, Chairman of the Management Board of RUSNANO Management Company.
TestGen: genetic tests
The main work of Andrey Toropovsky's teams focused on the development of genetic systems to identify traces of marker genes that speak of certain human diseases.
Today it is one of the most advanced and modern technologies, since a number of inventions use discoveries made only 5-10 years ago.
So, with the participation of specialists of the companies, test systems for diagnostics were developed:
- hereditary deafness;
- retinopathy and acquired blindness in diabetes;
- cervical cancer;
- the sex of the child by the blood of a pregnant woman;
- the Rh factor of the fetus;
- prostate cancer.
The developments have no analogues and, at the moment, except in Ulyanovsk, are not produced anywhere else.
A number of these genetic tests do not even require blood sampling or punctures – unlike many analogues, smears are enough to determine pathology.
Another distinctive feature of the systems was the possibility of early diagnosis using genetic tests: for example, test systems for the diagnosis of cancer are applicable at the earliest stages of the disease.
When the disease is detected at this stage, no serious surgical interventions are required, therefore, test systems will allow treatment without consequences for a person, and make the diagnosis simple and mass.
"TestGen" against COVID-19
The company was not only able to develop a unique product in Russian conditions, but also to launch its mass production on Russian territory.
It is not surprising that the company's developers at the time of the pandemic were the first teams to decide to use the proven technology to detect foreign microorganisms.
The patent application was filed on April 15, on May 15, 2020, the corresponding test system was approved for use by the Ministry of Health of Russia, and on May 18, mass production of test systems began.
The first delivery to Ulyanovsk hospitals was carried out the next day, May 19.
And already on May 21, after receiving the appropriate certificate, the test became ready for delivery to the European market.
The Ulyanovsk company produces fully ready-to-use kits. They include:
- RNA isolation kit,
- ready buffer for single-stage reverse transcription and polymerase chain reaction (RT-PCR) in real time,
- a multiplex mixture of primers and probes to detect a specific (FDA-recommended) section of the genome of a new type of coronavirus,
- control samples (positive and negative),
- an internal control sample (based on RNA) to determine false-negative results.
The kit is designed for simultaneous testing of 94 samples, that is, doctors can simultaneously conduct 94 analyses.
How does the Ulyanovsk COVID test work?
The development of the CoV-2-Test is based on the method of polymerase chain reaction in real time with reverse transcription, which determines the genetic material of the virus.
A sample for analysis is a biomaterial taken from the mucous membrane of the nose or mouth of a potential patient, or sputum from the lungs.
Testing takes about 2 hours:
1. The collected biomaterial is transferred to laboratory assistants or taken to the laboratory.
2. The laboratory assistant opens the package "CoV-2-Test" and conducts PCR testing according to the standard procedure.
3. The results are additionally checked using one of the components of the test set.
4. After 2 hours of test work using "CoV-2-Test", the laboratory assistant will become clear whether the patient is infected or not.
The polymerase chain reaction can be described very conditionally as follows (you can read more here):
1. A sample containing nucleic acids is placed in a special medium.
2. In it, under the influence of temperatures and enzymes, the splitting of DNA / RNA chains occurs.
3. Special marker chains are attached to the desired chains from the sample.
4. The resulting chains are compared with test matrices.
All this happens in several iterations, allowing you to find specific pieces of DNA/RNA with great accuracy.
Even if the nucleic acid of the virus (a new type of coronavirus contains RNA) is completely mixed with the nucleotides of standard human satellites or pathogens, it will be given out by certain areas specific exclusively to a particular "species".
Promotional samples of "CoV-2-Test".
As stated in the FDA recommendations, PCR is the method on which the tests of the Ulyanovsk company are based, today the most accurate and reliable method for diagnosing a viral infection: it allows you to recognize RNA chains in the collected biomaterial and find viral ones among them.
There are suitable clinical laboratories all over Russia. The PCR technique is quite common, so you can implement the Ulyanovsk COVID test anywhere without deploying additional infrastructure.
Specialists of the relevant laboratories or research centers only need to do everything according to the instructions out of the box, using a robot or manually.
Such robots can conduct from 800 tests per day each.
The test system allows you to analyze 1 sample in 2 minutes in an automated mode using standard robotic laboratory stations. The result will be in 2 hours.
Or 800 tests per day at one workplace. With manual work per shift, one laboratory assistant can qualitatively isolate the RNA of the virus from about 100 samples.
It is important that the infrastructure and the work of the staff cost almost 70% of the total price of the analysis: the test system takes only 30%. This means that already equipped laboratories will be able to reduce the cost of testing multiple times.
According to Denis Viktorov, Candidate of Biological Sciences, head of the laboratory of scientific and Technical development of the TestGen company, the test determines even single inclusions of the virus RNA of exactly the right type in human biological material. By the way, the system can be upgraded as the virus evolves.
This helps to detect the disease in the incubation period and at the earliest stages. During the development of the test system, the recommendations of the FDA were also taken into account.
The results of testing the test system were clinically tested at the Federal State Medical Institution "Head Center of Hygiene and Epidemiology of the FMBA of Russia" (Moscow), showing an accuracy of 96-100% with proper analysis at all its stages.
To determine infection, a concentration of 500 copies of the virus in 1 ml of biomaterial is required – this corresponds to the incubation period of the disease and even the moment of infection.
Now "TestGen" It produces 50 thousand tests per day, but if necessary, the production capacity can be increased to 2 million per month.
Prospects of "TestGen" and are there any competitors?
At the moment, TestGen test systems are massively used in determining the SARS-CoV-2 coronavirus in the Ulyanovsk region, there is data on deliveries throughout Russia.
The easily executable methodology and the presence of many suitable laboratories around the world, as well as the participation of TestGen in the RUSNANO Group, suggest that in the very near future the system will become one of the main ones in Russia.
With a certain luck – and all over the world. According to the CEO of TestGen, in June, requests for the purchase of tests were received from Ireland, Sweden, Germany, the Czech Republic, and the Netherlands.
The competition of the Ulyanovsk company will be made up of the Trinity Engineering Center from the TechnoSpark Group with the Federal Scientific and Clinical Center of Physico-Chemical Medicine (FNCC FHM) of the FMBA.
Their association has developed an analyzer device "Indicator-BIO", capable of detecting dangerous viruses in 15 minutes - at the moment, the system has already been adapted to detect SARS–CoV-2.
In addition, there is a Russian company "Evogen", which, in cooperation with the Japanese K.K. Mirai Genomics, creates devices for mobile diagnostics of the coronavirus "Evotek-Mirai Genomics".
Nevertheless, Ulyanovsk biostartapers count not only on active sales of the current development, but also on a serious improvement of the system in the future.
One of the next steps should be a ready-made device for instant high-precision mobile diagnostics, suitable even for use at home.
P.S. "TestGen" can be helped in the fight against coronavirus right now – the company is actively looking for new employees all over Russia. According to rumors, they offer good conditions and prospects.
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