Verificación del desempeño analítico del método cuantitativo de glucosa mediante la aplicación de las guías ep10-a2 y ep15-a2 de la clsi, en el centro de investigación translacional y servicio a la comunidad de la Universidad Técnica de Ambato

Abstract

The clinical laboratory must maintain the quality of all the results issued, these will need for the diagnosis and monitoring of the health status of people in the short, medium or long term, so in the following investigation the method for Glucose was verified with which The Research Center of the Technical University of Ambato is working. The importance of this investigation is based on the determination of the value of the pressure, truth and total error allowed of the method and this was compared with the quality requirements of the commercial house, with this verification in the future this process can be incorporated into the laboratory for other types of analytes. An analytical design proposed by the CLSI guides was designed with quality control material ClinChem1 and ClinChem2 of the Roche Diagnostic commercial house, these were reconstituted and preserved at an average temperature of -22 ° C, the aliquots were processed in chemistry equipment Cobas C111, obtaining as a result ClinChem1 a DS 0.79 mg /dL and a CV 0.79% intraday, for ClinChem2 a DS 2.5mg /dL and a CV of 1.06% for accuracy. With the normal control the veracity was calculated being the relative error of 1.66%. Finally, the coefficient of intra individual biological variability 0.30 this is less than reported 0.50, that is, the method is within a desirable range. The total error for the glucose analysis is 10%, the glucose analysis in this test was 7.8%, and it still within the limit. The update of these analysis tools, allows to know the panic and clinical importance values, validating the results with greater efficiency, safety and speed, to then be immediately reported to the clinical doctor, to reduce errors in diagnosis and expedite the taking of medical decisions.