[The multi-central clinical laboratory study of precision of the portative glucometer "Satellite Plus"]

The analysis of 482 blood samples of patients with diabetes mellitus type I and II and healthy persons was made using the portative glucometer "Satellite Plus". The comparison with reference analyzer was made. The results of clinical laboratory tests demonstrated that this glucometer meets the precision requirements of inter-national standard ISO 15197:2003 (97.5% of results are in the limits of standard deviation). The evaluation of results using the technique of analysis of errors array for patients with diabetes mellitus type 1 demonstrated that 99.4% (479 out of 482) were in zone A i.e. are clinically accurate results. The measurement results capable to negatively impact the clinical course of disease, to represent significant medical risk and to result in dangerous outcomes were not registered. So, the portative glucometer "Satellite Plus" can be recommended to detect the concentration of glucose in capillary blood for self-control of the glycaemia level in patients with diabetes mellitus. The device can be applied too for express-diagnostics in conditions of emergency medical care rendering by medical personnel.