The Federal Service for Surveillance on Consumer Rights Protection and Human Welfare (Rospotrebnadzor) has developed an innovative high-precision test for express diagnostics of COVID-19, the press service of the department reports.
“FBSI Central Research Institute of Epidemiology of Rospotrebnadzor has developed a new test for the rapid detection of nucleic acids SARS-CoV-2, the causative agent of a new coronavirus infection. A new set of reagents for rapid analysis for COVID-19 can reduce the amplification time by five or more times, and the total testing time by three to four times. For clinical samples with high and medium viral loads, the sensitivity and specificity indicators were 100%. The total testing time will be 1-1.5 hours, depending on the sample, versus four to five hours with conventional PCR,”the report says.
As explained, the test is based on the technology of loop isothermal amplification (LAMP, from the English "Loop mediated isothermal AMPlification"), amplification of nucleic acids occurs at a constant temperature, without changing temperature cycles. This method of amplifying nucleic acids makes the detection of DNA or RNA of the pathogen in clinical material faster and easier than conventional tests based on classical PCR, without any significant loss in efficiency. The speed, simplicity and low cost of LAMP technology make it possible to use it to monitor the spread of the coronavirus.
“The test is fully adapted for use on the basis of the infrastructure of laboratory diagnostics existing in the country, while absolutely all components for it are now produced locally on the basis of the Federal Budgetary Scientific Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor. This allows you not to depend on supplies from abroad, control production and make testing itself available to the population of the country. The diagnostic kit has already been successfully tested in other institutes and meets all modern European requirements. Registration certificate for AmpliSens SARS-CoV-2-IT set, form two, series 20.01.21, number RZN 2021/13357, was received on February 3 of this year,”the article says.
At the same time, with the help of a new test, it is possible to identify carriers of the COVID-19 virus at an early stage, promptly limit social contacts and strengthen medical supervision.
“Due to the aforementioned advantages, the rapid analysis can be used as the main point of care test (POCT), which is vital for tracking the transmission of the virus,” the press service concluded.