Test systems developed by the innovative biotechnological company Sistema-Biotech, which is part of the AFK Sistema group, are capable of detecting mutant strains of coronavirus, including the British strain and strains with other common mutations. This is stated in a study conducted by the company.
The first test system for detecting coronavirus is a set of reagents for detecting the RNA of the causative agent of coronavirus infection by the polymerase chain reaction (PCR) method in real time.
The company also developed two express tests based on the principle of loop isothermal amplification, which can reduce the reaction time to less than half an hour. One of these tests is intended for use in a standard diagnostic laboratory, and the other is colorimetric, or color, and allows you to determine the presence of the virus with the naked eye, by changing the color of the liquid in a test tube, for example, right at the patient's bedside.
Computer analysis of the SARS-CoV-2 genome showed that the 3CL proteinase gene is one of the genes most rarely affected by mutations. Based on this data and information that was collected on SARS-CoV-2 by March 2020, the researchers of Sistema-Biotech, even during the development of their first test system, focused on the 3CL gene as a target for detecting the virus and selected for this the corresponding primers.
In the British strain, the 3CL proteinase gene is also unchanged, although this strain accumulated 23 mutations in other genes. Thus, PCR tests of the Sistema-Biotech company make it possible to effectively and accurately detect coronavirus infection, despite British mutations.
Also, British mutations do not affect the operation of the other two – isothermal express tests produced by Sistema-Biotech.
“By choosing the 3CL proteinase gene for the selection of primers, our developers initially incorporated a large margin of safety into the test system. Having studied in advance the mutational landscape of related viruses, including the 2003 SARS virus, our researchers came to the conclusion that mutations in this gene, as a rule, are incompatible with life for the virus, therefore it remains unchanged, and the test system aimed at it will benefit from a prolonged pandemic. Indeed, none of the 23 British mutations hit the 3CL gene, ”said Natalya Pozdnyakova, Science Director of Sistema-Biotech.
