One stroke
Flu and COVID will be diagnosed at the same time
Ekaterina Yasakova, Izvestia
The first test system has been registered in Russia, which allows you to find out if a person is sick with COVID-19 or the flu, or is a carrier of both viruses at once. Its developer is already preparing to deliver the first batches to the laboratory. About 10 more Russian companies are waiting for the registration of such tests. One of them is engaged in the creation of a system that also identifies various types of SARS. A separate test for each pathogen will always be more accurate than for their totality, scientists believe. However, according to experts, the development should be considered a real revolution in the diagnostics market.
Four in one
In Russia, tests have appeared that allow one biomaterial to find out whether a person is sick with the flu or coronavirus, Izvestia found out. According to NextBio, on December 3, 2020, they were the first to receive a registration certificate for the corresponding system (the document is at the disposal of Izvestia).
– We have registered a kit that combines the diagnosis of a new type of coronavirus, influenza A, influenza B and subtype H1pdm09 (pandemic "swine flu" of 2009). The demand for our development in Russia is very high now, so we plan to sell all products on the domestic market first, then in the CIS and only then abroad. In Europe, they are already interested in the novelty," Oleg Lavinyukov, the company's director, told Izvestia.
Such test systems will be used in laboratory conditions. A swab is taken from a person, as is the case with conventional covid tests, then the RNA of the virus is isolated in order to conduct PCR. Using one test tube with a mixture of reagents, in about two hours you can find out which of the viruses the patient has.
– We have been engaged in this development since April 2020. In two weeks, the first batches will go to the laboratories. Distributors will decide which organizations will receive the test systems first. Most likely, they are from Moscow," said Alexander Gushchin, Director of Science at NextBio.
In a couple of months, the company will be able to produce a million tests per month, Oleg Lavinyukov added.
Roszdravnadzor confirmed to Izvestia the registration and admission to circulation of a set of reagents for the detection of coronavirus RNA and influenza A, B viruses, subtype H1pdm09 (pandemic) influenza A by RT-PCR in real time, created by NextBio.
Currently, the state registration procedure is being carried out with reagent kits for detecting SARS-CoV-2 coronavirus RNA and influenza viruses by polymerase chain reaction of the companies NPF Litech and DNA Technology TS, the ministry said.
Izvestia sent requests to the Ministry of Health and Rospotrebnadzor in order to find out which government agencies are developing similar systems.
Let's go to Europe
A similar test system was registered by DNA-Technology TS in Europe at the end of 2020.
– Such a kit is already sold abroad for laboratory diagnostics, but it is not yet available in Russia. One sample costs a little more than the usual coronavirus test. In our case – by 10-20%, – the company's CEO Vladimir Kolin told Izvestia.
In January-February, complex test systems of other companies can also be registered, according to Alexey Naumov, director of NPF Litech. According to him, there are no more than 10 players in Russia who are currently engaged in such technology.
Soon it will be possible to carry out simultaneous diagnostics, including for various types of acute respiratory viral infections, the Novosibirsk company "Vector-Best" noted.
– We have completed the development of test systems for the diagnosis of acute respiratory infections, including kits for differential diagnosis of various coronaviruses, influenza, rhinovirus, etc. We conducted all the necessary tests. The kits showed high sensitivity and specificity. We hope to successfully pass the state registration procedure in the spring of this year," said Alexander Kravtsov, Deputy General Director for Development of the company.
The right course
A combined test system for coronavirus and influenza created in the USA is known, Stanislav Markushin, head of the Laboratory of Genetics of RNA-containing Viruses at the I.I. Mechnikov Research Institute of Vaccines and Serums, explained to Izvestia.
– The American test system is called CDC Influenza SARS -CoV-2 (Flu SC2) Multiplex Assay. It is produced in the Centers for Disease Control and Prevention. We don't have exact data on this system yet, and it's still difficult to judge its effectiveness," Stanislav Markushin said.
Such developments in Russia deserve approval, in turn, said Professor Alexander Butenko, head of the Department of the N.F. Gamalei Research Institute of Epidemiology and Microbiology.
– The creation of test systems requires a lot of money, it is necessary to conduct a lot of research confirming the effectiveness of their use. Therefore, work in this direction should only be welcomed," the expert is sure.
At the same time, there are disadvantages in such diagnostics. A separate test for each individual pathogen will always be more accurate than for their totality, said Pavel Volchkov, head of the MIPT Genomic Engineering Laboratory.
– Combining the coronavirus with the influenza A and B virus in the test is still only the beginning of a long journey. People are sick not only with the flu and coronavirus, the number of infections is huge. It is very correct to have a test system that will show that a person is sick with, say, rhinovirus. This will enable pharmaceutical companies to produce drugs against a specific pathogen. That is, now there is a real revolution in this direction," Pavel Volchkov noted.
The scientist did not rule out the possibility of mistakes and shortcomings in the first stages of this revolution. At the same time, according to him, after a while people will already use express tests against a variety of infections and order the right drug through an online application.
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