ABSTRACT
Las mediciones confiables, trazables metrológicamente y comparables proporcionan la base racional para la evaluación de la calidad de un resultado y el fortalecimiento de las redes de laboratorios clínicos, lo cual permite mejorar la calidad de atención y la seguridad del paciente. En este documento se revisan los principios básicos que deben seguirse para garantizar la trazabilidad de las mediciones del laboratorio clínico, las ventajas de utilizar métodos trazables, el impacto de no hacerlo, y se discuten las principales limitaciones para relacionar las mediciones con los estándares de medición de referencia apropiados
Reliable, metrologically traceable, and comparable measurements provide the rationale for evaluating the quality of a result and strengthening clinical laboratory networks, thereby improving quality of care and patient safety. This document reviews the basic principles that must be followed to ensure the traceability of clinical laboratory results, the advantages of using traceable methods, the impact of not doing so, and the main limitations in relating measurements to appropriate reference standards
Subject(s)
Data Accuracy , Reagent Kits, Diagnostic , Reference Standards , Calibration , Equipment and Supplies , International System of UnitsABSTRACT
Objective Using the frozen human-pooled serum samples,with values assigned by the enzyme reference procedure in laboratory network to explore the way of quantity value transfer from enzyme reference measurement system to routine ones.Methods The study is about quantity value transfer.The frozen human-pooled serum sample was assigned by the enzyme reference laboratory network including six domestic reference procedure laboratories,namely Beijing Chaoyang Hospital affiliate of Capital University of Medical Sciences,Beijing Aerospace general Hospital,Beijing Shijitan Hospital affiliate of Capital University of Medical Sciences,Peking Union Medical College Hospital,Beijing Leadman Biochemistry Co.,Ltd.and Sichuan Maker Biotechnology Co.,Ltd.,which used the reference measurement procedures of creatine kinase (CK) and lactate dehydrogenase (LDH) from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).First,the assigned serum was used to calibrate or verify trueness of routine measurement systems from the 49 laboratories of tertiary hospitals in Beijing in Feb,2013 by Beijing Centerfor Clinical Laboratories.Second,the assigned serum and two levels of patient samples were tested in duplicate by laboratory 's measurement systems after calibration with manufacturer's calibrator and with assigned serum.During this procedure,all laboratories data were collected.Harmonization of results was observed after calibration with the assigned serum according to the statistics.Results After calibration,the interlaboratory coefficients of variation (CVs) of two patient samples were decreased from 4.67％ and 5.96％ to 1.86％ and 1.47％ for CK and from 5.72％ and 5.04％ to 3.67％ and 3.62％ for LDH.For peer group of A and B instrument,after calibration,both CVs of the assigned serum and two patient samples were less than 2％ for CK,and less than 4％ for LDH ; For C instrument group,which was not calibrated with the assigned serum,the biases were-4.75％ for CK and-13.1％ for LDH,while the biggest CVs were 3.64％ for CK and 7.57％ for LDH.For peer group of reagents,after calibration,the CVs were decreased from 1.60％-4.44％ to 0.23％-1.62％ for CK and from 0.93％-6.07％ to 1.06％-2.72％ for LDH.Conclusions It is one of the feasible ways for quantity value transfer by using the frozen human-pooled serum samples,which were assigned by the enzyme reference laboratory network for calibration or verification.It can effectively solve the problem of trueness and harmonization of enzyme testing results.In addition,for those measurement systems which are not applicable for this calibration.
ABSTRACT
OBJETIVO: Desenvolver um método e um dispositivo para quantificar a visão em candela (cd). Os estudos de medida da visão são importantes para todas as ciências visuais. MÉTODOS: É um estudo teórico e experimental. Foram descritos os detalhes do método psicofísico e da calibração do dispositivo. Foram realizados testes preliminares em voluntários. RESULTADOS: É um teste psicofísico simples e com resultado expresso em unidades do sistema internacional de medidas. Com a descrição técnica será possível reproduzir o experimento em outros centros de pesquisa. CONCLUSÃO: Os resultados aferidos em intensidade luminosa (cd) são uma opção para estudo visual. Esses resultados possibilitarão extrapolar medidas para modelos matemáticos e para simular efeitos individuais com dados aberrométricos.
PURPOSE: To develop a method and a device for vision measurement in candela (cd). Vision measurement studies are important to all visual sciences. METHODS:It is a theoretical and experimental study. The details of psychophysical method and device calibration were described. Preliminary tests were performed on volunteers. RESULTS:It is a simple psychophysical test and results are expressed in International System of Units. With this technical description it will be possible to reproduce the experiment in others research centers. CONCLUSION: The results measured in luminous intensity (cd) are an option for visual studies. These results allow to extrapolate measurements for mathematical models and to simulate data for individual aberrometry effects.
Subject(s)
Humans , International System of Units/instrumentation , Vision Tests/methods , Algorithms , Equipment Design , Models, Theoretical , Pattern Recognition, Visual , Photic Stimulation , Psychophysics , Reproducibility of Results , Vision Tests/instrumentation , Visual Acuity/physiology , Visual Perception/physiologyABSTRACT
This article summarized recent correlative literatures focusing on international standards on glycated hemoglobin.The basic concept,determination of glycated hemoglobin,the present review in laboratory measurement and metrological traceability was introduced.The international community has established reference system and metrological traceability to the International System of Units on HbA1c.Determination in glycated hemoglobin is still in incipient stage in our country.Both clinical laboratorians awareness and clinical determination need to be strengthened.