First PCR test to detect malaria registered in Russia

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The Central Research Institute of Epidemiology of Rospotrebnadzor developed and registered the country’s first PCR test for diagnosing malaria, the supervisory authority said.

“The test has high analytical sensitivity, allowing infection detection even at low infection rates, as well as in the incubation and initial periods of the disease. This method avoids false positive results of microscopic analysis in the case of analysis of blood preparations of poor quality or by a specialist with insufficient qualifications, “the report said.

The AmpliSens set of reagents Plasmodium spp/P. falciparum/P. vivax-FL is designed to diagnose diseases caused by a group of malaria plasmodia (unicellular organisms) by qualitatively determining their DNA by PCR with hybridization-fluorescent detection of amplification products. The sensitivity of the method reaches 1-0.1 kl/μl of blood, which far exceeds the capabilities of current diagnostic methods – light microscopy and rapid tests. They have less sensitivity, as a result of which they can give false negative results.

The CNI Epidemiology kit can be used to screen residents of endemic territories, diagnose acute and chronic stages of disease in imported cases of malaria, as well as an additional method to microscopy in malaria-endemic territories.

The department notes that the registration certificate for the set of reagents was received on March 10, 2021, the number of the registration dossier RD-38593/103748 from 30.12.2020.

In 2020, 57 imported cases of malaria were registered in the Russian Federation, in January-February four imported cases.

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