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Órgano oficial de difusión de la Federación Mexicana de Patología Clínica, AC y de la Asociación Latinoamericana de Patología Clínica/Medicina de Laboratorio

2016, Number 1

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Rev Mex Patol Clin Med Lab 2016; 63 (1)

Performance evaluation of glucometer GLUCOCARDTM 01

Ramírez-Fernández NA, Pacheco-Cervantes A, Lira-Reyes AR

Language: Spanish
References: 11
Page: 24-29
PDF size: 261.08 Kb.


ABSTRACT

Introduction: Capillary blood glucose is the recommended method for the self monitoring of glucose in order to ensure the right insulin therapy, for that reason is important use a reliable measurement method. Objective: To verify the lineality and precision of the GLUCOCARDTM 01 meter and its correlation with an standard laboratory method. Method: The metodology we used is based in the CENAM/EMA guide and the manufacturer recomendations. For the statistical analysis we calculated correlation for lineality, coeficiente of variation (CV) and % bias. The system accuracy was determined based on ISO 15197:2003 recommendations. Results: For lineality r = 0.9991, precision: CV ‹ 5% in the four samples tested. About comparison between total blood analyzed in glucometer with serum in standard method r=0.9788, for total blood with heparin compared with serum in the standard method r= 0.9775. Referent to accuracy and based on ISO 15197:2003, we observed that more than 95% of the results gotten, fall into the group with a difference smaller or equal to 20% compared to the standard method. Conclusions: GLUCOCARDTM 01 is a lineal, accurate and precise method in accordance with international standars and can be used as a reliable self monitoring blood glucose device.


REFERENCES

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