Evaluation Of Measurement Uncertainty In Clinical Biochemistry And Discussion Its Application Value In Laboratory Medicine

As the quickly development of evidence-based medicine, disease diagnosis decision is now based on the currently available and best evidence, which proposed a higher request for laboratory medicine without any doubt. It is a major task for laboratory workers about how to provide fast and efficient test report to clinical doctors and users.The major task of clinical laboratory is to assign values for specimen characteristics of human body, and the assignment process is according to the actual situation. The accuracy, reliability and dispersion of the value will directly affect the diagnosis, treatment scheme and efficacy of the disease. So, the standard ISO15189-Medical laboratories-Particular requirements for quality and competence, which was published by the International Organization for Standardization(ISO), clearly points out that the uncertainty of test results should be determined when it’s necessary and possible. Measurement uncertainty which is a parameter, is associated with the result of the measurement characterises and the dispersion of the values which could reasonably be attributed to the measure. In order to characterize the dispersion, the measurement uncertainty is expressed by the standard deviation. In clinical biochemical test, the measurement uncertainty can not only improve the accuracy of the test results, but also can effectively reduce the error, and both of them have practical application value. At the same time, a reasonable assessment can identify the major source of measurement uncertainty,and then establish the quality management indicators, and finally continuous improvement of the laboratory will be achieved,with sustained and healthy development of laboratory medicine.Objective:To discuss the application value of measurement uncertainty in clinical biochemical detection. Methods:Roche D2400 biochemical analyzer and its matching reagents, calibration products, etc were used. Within-run repeatability, the IQC results of JSCCL and the EQA results of NCCL were used to calculate the uncertainty components;Within-run analysis(CVw),between-run analysis(CVb) and methods bias(CVbias) were used to calculate synthetic and expanded uncertainty (U%). Results:Because of the biochemical test items in our lab were affected by various and different factors, the results of measurement uncertainty were different from each other. CVb and CVbias were the main contribution of the component for bigger expanded uncertainty. It also demonstrated that the quality of biochemical test items could be further improved. The U% of lower concentration of TBIL, ALT,AST, ALP, CK, DBIL, TG were all more than 10 as well as the higher concentration of TBIL, ALT, ALP, CK, DBIL, which explained that, the fluctuation between the measured results and value was great. Conclusion: Measurement uncertainty could reflect the accuracy and dispersion of clinical biochemistry test results, the quality of clinical biochemistry tests could be provided a basis of appropriate improvement by the contribution of the degree of uncertainty components, it’s very important to clinical application.