Today in Russia was 24 test system for the identification of new coronavirus infection COVID-19, and to judge the quality of diagnosis can professionals working directly with the test system. About PCR tests to determine the RNA of the coronavirus SARS-CoV-2 of “Mediplex” tell those who already use them in their daily practice.
The Russian company “Mediplex” in terms of epidemiological turbulence quickly refocused its activities on the development and production of PCR tests for reliable detection of RNA of the coronavirus SARS-CoV-2 in smears from the nasal cavity and the oropharynx. Set is used in government and commercial clinical diagnostic laboratories. Today, the company provides tests for coronavirus infection of the health institution of the Moscow region and other regions of Russia.
We talked with specialists of the Moscow regional public health on how to cope with the test tasks.
Dmitry Yakunin, head of the laboratory of the Moscow regional station of blood transfusion: “we in the suburban laboratories successfully use the data of the PCR tests. Other, the first test systems that appeared in the beginning of the epidemic, due to the lack of sufficient time, was prompt, but “on the knee” and demanded more time to work. In particular – then the next step was reverse transcription. Now with new tests, this process has become much simpler: we do not need to allocate a separate place, where it will undergo this reverse transcription.”
Elena Sineva, head of the laboratory in GBUZ MO “Royal hospital” also shared the experience with PCR-based tests: “We started working with tests “Mediplex” from the 17th of April. At the moment the tests satisfy us completely. These tests are done on the system “all inclusive”: the them reverse transcription is included in the reaction. So the work goes quickly, efficiently, and no complaints from us – neither in the controls nor in the reaction. All stages are perfect. I think that definitely we can say that these tests are not inferior to Western counterparts. The PCR tests that we work with index virus in the third degree. For comparison: before that it was the chemicals that are indexed only in the fifth degree, that is up to five amplificati. Now we test in this way: if there is a virus there, we find him already faster on the third take. Moreover, these tests are more sensitive”.
Over the past month the company “Mediplex” produced over 400,000 tests, half of which are already used for testing of real patients. Until the end of may is planned the release of a million test systems.
“Hypersensitivity is important in the beginning and at the end of the infectious process, when the coronavirus is still little or have little smears, and the person can already transmit the virus to another. According to the results of clinical trials, we achieved a sensitivity of 1-2 copies of RNA to the reaction, this corresponds to hundreds of viral particles in the smear – if only they got under the fence material.
The situation with the pandemic does not seem to me close to completion. After the lifting of restrictive measures – though gradual – we expect new outbreaks. Let them be and not such scale as during the main period of the pandemic, but the problem COVID-19 will accompany us (and all mankind) until the advent of vaccines and mass vaccination coverage – that is, another year and a half at least. The recent outbreak in the North of China – only the first re that await the world in the near future. Fortunately, health care, administration, and we – the producers – now I feel much more confident. For their part say that the problem of lack of tests, apparently, finally solved. For example, we have a good operational margin and within a couple of days to send the right amount in any point of Russia. I think other productions too, everything fell into robust rails. Now you can solve other tasks, to expand the line – in particular, we on the way to own antibody test. I think in the context of determining population immunity it will be in demand” – ends the conversation General Director of “Mediplex”, C.b.N. Viktor Manuilov.
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