Verificación del desempeño analítico de la precisión y veracidad de varios analitos de química clínica en el Laboratorio Clínico e Histopatológico Sucre de la ciudad de Riobamba.

Abstract

The research deals with the verification of the analytical performance of the accuracy and veracity of various analytes of Clinical Chemistry at Laboratorio Clínico e Histopatologico “Sucre” of Riobamba. According to ISO 16189:2012 test procedures used whitout modification should be subject to verification by an independent laboratory before traducing as routine method. In order to verify throuhg the provision of objetive evidence that the method is according to the signs of the manufacturer to the analytes: urea, glucose, cratinine, urci acid, total colesterol, HDL colesterol, LDL colesterol, Triglycerides, total bilirubin, direct bilirubin, alkaline phosphatase, SGTO, SGTP, GGT, totak protein, Albumin, to thereby meet the needs of the patient did have a reliabe result. It was performed the process proposed by the Instituto de Normas Clínicas y de Laboratorio(CLSI). Document EP15-A2, 2005, constituting this one of the most accepted guides at international level with a wide variety of resources and a process rigorous enought to provide statistically valid conclusions for verification Studies. With the data in the lab a SDr and SDi was obtained for each analyte that was less tan or equal to the check value obtained with the manufacturer´s specifications and for studing veracity reference material was used which was analyzed after performing the corresponding Statistical analysis verification is accepted. We conclude that the results issued by the Laboratorio Clínico e Histopatológico “Sucre” are precise, accurate and method performance meets the manufacturer´s specifications for Clinical Chemistry analytes, providing confidence to riobambeña population. It is recommended –in general terms- the implementation and monitoring of internal and external control Quality in clinical laboratory.