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Healthcare watchdog certifies express COVID-19 test developed by Russian scientists

The test system is based on the loop-mediated isothermal amplification technique which helps detect viral RNA and DNA

NOVOSIBIRSK, November 25. /TASS/. A new system for the rapid detection of coronavirus in less time than a PCR test that was developed at the Institute of Chemical Biology and Fundamental Medicine of the Siberian Branch of the Russian Academy of Sciences has been certified by the Federal Service for Surveillance in Healthcare and permitted for use in the Russian Federation, the institute’s press service told TASS on Thursday.

"The institute obtained a registration certificate for a medical product of a set of reagents for a qualitative detection of SARS-CoV-2 coronavirus’ RNA in human nasal or oral swabs," the press service said.

The institute’s commercial partner is OOO SLT (Modern Laboratory Technologies) located in the Koltsovo science city. "The key components used in production are made in Russia. It is planned to implement the kit in clinical practice with a view for export abroad," the press service said.

The test system is based on the loop-mediated isothermal amplification (LAMP) technique which helps detect viral RNA and DNA. While rather high sensitivity is preserved, the performance of the test takes about 30 minutes which is significantly less than the traditional PCR analysis. As result, the number of tests performed by laboratories increases.

No expensive equipment used by stationary laboratories is needed to conduct these tests. In the future, this method can be used for express diagnostics outside of specialized laboratories, for example, right at an airport terminal. Such testing will make it possible both to detect patients at an early stage of the infection for subsequent therapy and to disrupt the chains of infection, decreasing the rate of spread of SARS-CoV-2.

The Institute of Chemical Biology and Fundamental Medicine of the Siberian Branch of the Russian Academy of Sciences, previously the Novosibirsk Institute of Bioorganic Chemistry of the Siberian Branch of the Russian Academy of Sciences was founded on April 1, 1984, on the basis of the Department of Biochemistry of the Novosibirsk Institute of Organic Chemistry of the Siberian Branch of the Russian Academy of Sciences. The institute carries out intensive research into the metabolic enzymes of nucleic acids.