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Portable analyzer for quick SARS-CoV-2 tests

Solution description
"Isotherm" is a project of creating a portable diagnostic device for the detection of SARS-CoV-2. Device is also capable of other virus detection. The project is based on the LAMP (loop-mediated isothermal amplification) method. The project includes an isothermal-PCR test system (reagent kits) of a Medical Biological Union (MBU) company and an analyzer developed by SmartDive Technologies company for MBU.

The PCR (polymerase chain reaction) method for the SARS-Cov-2 diagnosis is used widely in the world due to its effectiveness and availability. The PCR method is focused on detection of a specific sample of DNA or RNA by significantly increasing the number of copies of it. There are a lot of PCR methods developed by the industry, but most of them require experienced technicians and a sophisticated laboratory with specialized measuring equipment. Before setting up the reaction, a laboratory assistant must conduct a long sample preparation (1.5-2 hours). One detection cycle of common PCR methods takes up to 1.5-2 hours. So the total testing time is 3-4 hours.
The test system (reagent kit) of the project is based on LAMP technology and allows:
  • to get the results of each SARS-CoV-2 analysis cycle in 20 minutes (vs. 3-4 hours with other methods);
  • to use express sample preparation (5 minutes) in any field conditions without the need for sophisticated equipment.
The test system (reagent kit) has already been certified in Russia (on April 2th 2020) and moved to the mass production stage. Now the test system can already be used in specialized laboratories for the diagnosis of SARS-CoV-2. Production capacity is ~1 million test kits per month.
The portable analyzer would allow:
  • to simplify the sample preparation procedure and thereby reduce the time required for sample preparation and analysis itself, reduce the likelihood of error;
  • to simplify the requirements for the personnel conducting the test, and for the place of analysis. The device could be operated by non-medical personnel, for example, police officers, airports employees, etc;
  • to make tests in places where fast screening is needed (schools, train stations, airports, ambulance vehicles, etc).
The new analyzer will reduce current bottlenecks in testing.
It is important that "Isotherm" would be connected to the central information system of the hospital / test center, so that all data from the analyzers could be processed centrally for extra analytics. This will improve development not only in the field of diagnostics, but also in treatment and vaccination (for example, it will be possible to obtain information about repeated tests or diseases of one person).

The new method of testing will help to more clearly identify and separate infected people and thereby restrain the spread of the pandemic by more targeted quarantine measures.
SmartDive Technologies has 5 years of experience in designing and manufacturing of similar devices. More than 10 devices in portfolio, incl. 6 medical devices.

There are 20 qualified developers of hardware and software in SmartDive Technologies team.
SmartDive Technologies has a proven supply chain for more than 5 years.
SmartDive Technologies is operating in Portugal, Russia and USA.
There is a test system (kit of reagents) certified by the Ministry of Health of Russia.
The «Isotherm» device is in the final stages of development.
The measuring part of the device is successfully tested.
Several European countries are interested in the new «Isotherm» analyzer.
New «Isotherm» analyzer is very portable (~1kg, 220*200*180 mm), and so enables virus diagnostics at patient homes during ambulance team visits. This enables on-the-spot decision if a specific patient requires immediate hospitalization/quarantine, or can be left at home for softer treatment regime:
  • this gives a significant extra advantage on saving ambulance team time (so they have an option to leave this patient at home and go straight to the next call as opposed to getting this patient to hospital to make a virus test there and wait for the test result;
  • this enables more effective use of hospital beds, so that some patients do not occupy them if not critically justified.
Today there is not enough equipment in the world to make the necessary number of SARS-Cov-2 tests and control real statistics of the pandemic. To cope with pandemic the healthcare system would need to have excess diagnosis capacity, so that all our actions for diagnosis, treatment and vaccination would be done with realistic information about patients number and status.
Prototype of the «Isotherm» measurement unit is ready now
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«Isotherm» can be compared to two kinds of alternative equipment:
Previous lab setups based on PCR (non-LAMP PCR methods with multi-cycle DNA amplification) — see last item in the table about this group.
New LAMP-based test systems are now just coming to market, which are similar to proposed «Isotherm»:
  • Abbott has received emergency use authorization (EUA) from the U.S. FDA for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19) on March 27th 2020 to be used with Abbot ID Now platform;
  • Optigene. Details are in the table below.
While being similar in test technology (LAMP PCR), those new test systems are still remaining relatively expensive: Analyzers est. at $9-12k or more. Those devices (from Abbott and similar) keep relatively complicated bio-sample preparation procedures, which limit their use to professional labs. "Isotherm" enables broader field use, bringing test ability to the closest edge of pandemic fight.
Cartridge with reagents kit ~85*20 mm
0.2 ml tube
Biochemistry backgrounder
LAMP (loop-mediated isothermal amplification) method of PCR (polymerase chain reaction technology) has several features:
LAMP PCR does not require cycled changes of temperature of reagent mix, because synthesis of each copy of targeted DNA segment is done by DNA Polymerase Bst (extracted from Bacillus stearothermophilus), which is capable of splitting target DNA at lower temperatures ~60 C. Regular PCR is using Polymerase Taq (extracted from Thermophilus aquaticus), which is not capable to split target DNA, so cycled heating up to 94 degrees С is needed for the split and then cooling down and then repeated again. Regular (Cycled) PCR is using more complicated lab equipment, than isothermal PCR (LAMP).
The second feature of LAMP is the use of additional pairs of primers (unique sections of the virus genome by which the presence of the virus is determined by the sample). In most cycled PCR methods one pair of primers is used. That limits the beginning and end of the DNA segment under investigation. In the LAMP method additional primers are used. That's why cyclic loop structures are forming during the synthesis of a new DNA chain. It accelerates the reaction time. The detection of the results occurs by adding a fluorescent dye to the cartridge and the analysis results can be seen easily.
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