"SCREENSPOT©" - a microplate analyzer for reading test results based on the ELISPOT immunoassay method.
ELISPOT (Enzyme-Linked ImmunoSpot) is a method for the quantitative determination of cells that secrete specific products (cytokines, immunoglobulins, and other target proteins) in response to a specific activating agent. The results of blood tests for tuberculosis using the ELISPOT method are not dependent on the level of immunity or the presence of BCG vaccination, which gives it proven advantages over other tests in individuals with immunodeficiency diseases and conditions. This methodology is the basis for the "TigraTest© TB" reagent kit produced by GENERIUM, which is used for the detection of tuberculosis infection. Tests based on the ELISPOT method are included in clinical guidelines.
"This full-cycle project belongs to the complex category of medical equipment and serves as a prime example of effective collaboration between highly skilled teams of different specialties: biotechnologists from GENERIUM and engineers from the Troitsk Engineering Center. The software-hardware complex and reagents are entirely a Russian development, which allows for the production and use of the 'SCREENSPOT' analyzer without considering foreign factors. The use of a domestic analyzer in conjunction with the 'TigraTest TB' reagent kits significantly increases the speed of data processing obtained during diagnostic procedures," said Dmitry Kudlai, Vice President of GENERIUM and Corresponding Member of the Russian Academy of Sciences.
The device was developed by specialists from the Troitsk Engineering Center with scientific support from experts at GENERIUM. Clinical laboratory tests of the equipment were conducted on a large number of archived samples containing immunoenzymatic spots obtained using the IGRA ELISPOT method (diagnostic test 'TigraTest TB'). The results of the tests confirmed that with the help of specialized software, the analyzer automatically counts the number of spots, significantly accelerating the data processing process and reducing the likelihood of errors related to human factors. This device allows for digital imaging of microplates and subsequently enables detailed analysis.
"The production facilities of the Troitsk Engineering Center are fully prepared for the serial production of devices at a volume of up to 300 units per year, which will significantly improve the accuracy of research, reduce the invasiveness of the traditional method, and increase the scale of immunological diagnostics for tuberculosis infection in medical institutions across the country. The developed equipment can also be used for immunological diagnostics of cytomegalovirus, encephalitis, and borreliosis," said Evgeny Gorsky, Ph.D., CEO of LLC "TIC."
The equipment can be used by specialists with various levels of training, including clinical laboratory diagnostics physicians, medical laboratory technicians, and paramedics-laboratory assistants. The implementation of "SCREENSPOT" in medical practice will be an important step towards improving tuberculosis diagnostics, a socially significant disease that is widespread worldwide.