The LSLF-20 analyzer is designed for sensitive reading of results and interpretation of IVD tests of the company LOMINA SUPERBIO a.s. working on the principle of detection of nano-fluorescent spheres in an immuno-chromatographic reaction. The analyzer is used with POC test cartridges and reagents manufactured by LOMINA SUPERBIO a.s.
The analyzer is widely used in central laboratories, medical facilities, patients, emergency laboratories, clinical departments and other medical services (such as community clinics and general clinics), physiological examination centers, retirement homes, as well as sports facilities and corporate health services. The test kit with fluoro-luminescence immuno-chromatography can also be used for primary patient screening or medical examinations.
The analyzer was developed for a wide range of immuno-chromatographic fluorescence assays. Before use, the device must be set with a magnetic card to calibrate the device for a specific IVD test. In the case of quantitative tests, the calibration must be performed continuously. For qualitative tests, it is sufficient to calibrate the device only before the first use of the tested lot (LOT).
The LSLC-20 model is a new generation device specially modified in response to the spread of SARS-CoV-2 in 2019.
Tests to demonstrate performance were performed mainly on the Immuno-fluoro-luminescence IVD SARS-CoV-2 N-Protein Antigen Rapid Test (REF: LA-CoV-Ag).
The test is developed and tested for the general public for the use of blood samples taken from a finger.
The accuracy and repeatability of the in vitro diagnostic medical device FLUORESCENCE IMMUNOASSAY CHROMATOGRAPHY ANALYZER meets the set requirements.
Efficiency compared to reading with a UV lamp on POC test cartridges: 101%.
Based on the results, it can be said that the in vitro diagnostic medical device FLUORESCENCE IMMUNOASSAY CHROMATOGRAPHY ANALYZER has a higher sensitivity of POC test cartridges than the use of a UV lamp.
The analyzer meets the standards: EN 61010-2-101: 2002 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements
requirements for in vitro diagnostic medical devices (IVD) and EN 61326-2-6: 2006 Electrical measuring, control and laboratory equipment – EMC requirements – Part 2-6: Specific requirements – In vitro diagnostic medical devices (IVD) ( IEC 61326-2-6: 2020).