17 October, 2023
Expert Laboratory Technologies (ELTECH) and the analytical company Marketing Logic have developed a specialized complex «IGRA-TB», which includes software that allows detecting the immune response to tuberculosis with high accuracy and automatically interpreting obtained results.
The «IGRA-TB» complex consists of vacuum tubes for taking patients' blood and stimulating the lymphocytes in it with specially designed antigens, a set of reagents for determining the lymphocytic response and a software unit.
Data on the level of cytokines produced by lymphocytes in response to their presentation of mycobacterial antigens are loaded into the «IGRA-TB» software module. The program calculates the value of the lymphocytic response using algebraic algorithms and compares it with reference values corresponding to the presence or absence of tuberculosis infection in the patient's organism. After all, the program automatically uploads a table with the results and prints a conclusion. The conducted clinical trials have shown 100% accuracy of calculations and correct interpretation of the study results in comparison with Western tests.
“If a person is infected with mycobacteria, then T-lymphocytes specific to M. tuberculosis antigens circulate in his blood. We take a milliliter of blood from a person and add artificially synthesized fragments of such mycobacterial proteins to it. If the sample contains antigen-specific lymphocytes, they recognize our stimulator and react to it by producing cytokines, mainly gamma interferon, which is immunochemically determined in our kit. Then we compare the interferon gamma level after stimulation with what is found normally in the same patient, without the addition of any stimulants. If it is elevated, then it means that there are lymphocytes in the person’s blood that are “familiar” with the mycobacterium and, therefore, the person is infected. This method is known as interferon-gamma release assay (IGRA-test), which is why our complex is called IGRA-TB,” says Candidate of Biological Sciences, General Director of ELTECH Viktor Manuilov.
“5-10% of Russian population (depending on the region) are carriers of M. tuberculosis. Such carriage does not always lead to the disease, but does mean an increased risk of developing tuberculosis in the future. In particular, this is why all children under 17, by the way, this is 30 million people in Russia - are annually screened for tuberculosis infection. In most cases, skin tests are used for this - the well-known Mantoux reaction or the more modern «Diaskintest». They are cheap, require a subjective interpretation of the result (the doctor evaluates the reaction visually) and require a repeat visit to the diagnostic room. In addition, skin testing may cause a severe allergic reaction or other side effects. Therefore, the emergence of tests where the patient does not come into contact with mycobacterial proteins, in which the analysis is carried out on the blood within 24 hours, and the interpretation is carried out automatically, of course, means a more reliable and safer result for the patient. Similar tests are widely used in developed countries, but IGRA-TB represents the first such domestic development,”says leading researcher at the National Medical Research Center for Physiopulmanology and Infectious Diseases of the Russian Ministry of Health, Candidate of Biological Sciences Artyom Tkachuk.
Marketing Logic together with ELTECH have developed and tested an intuitive interface for the program that preserves all the elements of familiar office applications. The multi-data processing function is available, and both template-based and manual adjustment of analysis processing modes are also provided. The program is a desktop application and can work offline. From the point of view of architecture, the software can be configured for any tests with adaptation to the necessary calculations.
"The Marketing Logic team ensured the direct development of the software part and its compliance with the specified requirements. It was important for us to create algorithms that would cope as accurately as possible with their task of interpreting the results and generating reports-conclusions. Plus, ensuring maximum efficiency of algorithms and their accuracy, we tried not to overload laboratory systems, so the program copes with its tasks with minimal requirements for the operating system, processor and RAM. This is not our first biological project, so we try to take into account all the factors that correspond to reality, because this is the only way the solution will be as useful as possible, relieve specialists and help patients," says Dmitry Galkin, CEO of Marketing Logic.
The IGRA-TB reagent kit has completed clinical and laboratory tests in the manner prescribed by Russian legislation, and is currently undergoing registration as a medical product. Production facilities have been prepared in Dubna, and the launch of mass production is planned for the end of 2023.