A Russian company, Generium, has received registration for its medical device “ScreenSpot,” an analyzer designed for the automated reading and analysis of tuberculosis test results. This equipment is intended for use in clinical diagnostic laboratories, as reported by the company’s press service.
The device is based on the ELISPOT method (Enzyme-Linked ImmunoSpot), which is utilized for the quantitative determination of cells that secrete specific products (cytokines, immunoglobulins, and other target proteins) in response to a specific activating agent.
The blood test for tuberculosis using the ELISPOT method is independent of immunity levels and prior BCG vaccination, providing proven advantages over other tests for individuals with immunodeficiency diseases and conditions. This methodology underpins the “TigraTest® TB” reagent kit produced by Generium, which is used to detect tuberculosis infection.
Tests based on the ELISPOT method are included in the clinical guidelines of the Russian Ministry of Health. According to Dmitry Kudlay, Vice President of Generium, “This comprehensive project falls into a complex category of medical equipment… The software-hardware complex and reagents are entirely developed in Russia, allowing for the production and use of the ScreenSpot analyzer without foreign dependencies. Utilizing the domestic analyzer alongside the TigraTest reagent kits significantly increases the speed of data processing obtained during diagnostic procedures.”
The device was developed by specialists at the Troitsk Engineering Center with scientific support from Generium. Testing confirmed that the specialized software allows the analyzer to automatically count spots, significantly speeding up data processing and reducing human error. This device can generate digital images of microplates for detailed analysis.
The Troitsk Engineering Center’s production capacity will enable the manufacture of up to 300 units per year. The equipment can also be used for immunological diagnostics related to cytomegalovirus, encephalitis, and borreliosis.
