FMBA presents 2 test systems for identification of coronavirus, antibodies
MOSCOW. April 10 (Interfax) - Russia's Federal Medical and Biological Agency (FMBA) has said that it has presented a test system based on chips for diagnosing the novel coronavirus infection.
"This kind of testing is based on the technique of isothermal amplification, i. e. identification of the virus's RNA [ribonucleic acid]. Unlike the method of polymerase chain reaction (PCR), the RNA amplification takes place under a constant temperature of the reaction mixture and involves use of more productive kinds of ferments. Thanks to this, time needed for testing is reduced to 15-20 minutes compared to 90 minutes as is the case of classical PCR diagnostics," the FMBA press service said in a statement on Friday.
The FMBA has its own pilot-scale production of a microfluidic chip system. "Manufacture of the chips consists of three stages: formation of chips for isothermal testing on a laser machine, processing of those in plasma, and assembly on an ultrasonic machine. Methods of production, treatment and coagulation are adapted to the requirements of isothermal amplification. The pilot production has a capacity of more than 50 chips per day," the FMBA said.
The second test system that the FMBA demonstrated is "a 96-well plate with an optical registration of results," it said. "The [system] allows carrying out tests for the presence of SARS-CoV-2 [novel coronavirus infection] antibodies in a biological material. It is important to note that a detection of SARS-CoV-2 antibodies in a patient's serum allows tracing seroconversion, i.e. the period of time in which antibodies are formed in a human body, and consequently, resolution of the disease," the FMBA said in the statement.
The system that envisages an identification of antibodies in a biological material is to be submitted for state registration early next week, it said
"In view of the proven strong visual antiviral effect on a culture of infected cells, the FMBA of Russia is planning to check the anti-coronavirus effect in in-vivo models involving animals. Studying of clinical effects is carried out as part of the comparative study that has begun in three centers of the FMBA of Russia," the agency said.