Test from Rospotrebnadzor
Rospotrebnadzor has developed an innovative high-precision test for rapid diagnosis of COVID-19
The 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 on COVID-19 allows to reduce the amplification time by 5 or more times, and the total testing time by 3-4 times. For clinical samples with high and medium viral load, the sensitivity and specificity indicators were 100%. The total testing time will be 1-1.5 hours, depending on the sample, versus 4-5 hours with conventional PCR.
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 amplification of nucleic acids makes the detection of DNA or RNA of the pathogen in the clinical material faster and simpler than conventional tests based on classical PCR, without any significant losses in effectiveness. The speed, simplicity and low cost of LAMP technology allow it to be used to monitor the spread of the SARS-CoV-2 virus.
The test is fully adapted for use on the basis of the existing laboratory diagnostics infrastructure in the country, while absolutely all components for it are now produced locally on the basis of the Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor. This makes it possible not to depend on supplies from abroad, control production and make testing itself accessible to the population of the country. The diagnostic kit has already been successfully tested in other institutes and meets all modern European requirements. The registration certificate for the AmpliSense SARS-CoV-2-IT kit, form 2, series 20.01.21, RZN number 2021/13357 was received on February 03 of this year.
With the help of the new test, it is possible to identify carriers of the COVID-19 virus at an early stage, promptly limit social contacts and strengthen medical control. Due to the above advantages, rapid analysis can be used as the main test at the point of care (POCT), which is vital for tracking the transmission of the virus.
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