UNCERTAINTY OF MEASUREMENT IN LABORATORY MEDICINE

被引:33
作者
Milinkovic, Neda [1 ,2 ]
Ignjatovic, Svetlana [1 ,2 ]
Sumarac, Zorica [1 ]
Majkic-Singh, Nada [3 ]
机构
[1] Clin Ctr Serbia, Ctr Med Biochem, Visegradska 26, Belgrade 11000, Serbia
[2] Univ Belgrade, Sch Pharm, Dept Med Biochem, Belgrade, Serbia
[3] Soc Med Biochemists Serbia, Belgrade, Serbia
关键词
ISO; 15189; laboratory medicine; measurement uncertainty; CLINICAL-CHEMISTRY; TOTAL ERROR; TRACEABILITY;
D O I
10.2478/jomb-2018-0002
中图分类号
Q5 [生物化学]; Q7 [分子生物学];
学科分类号
071010 ; 081704 ;
摘要
An adequate assessment of the measurement uncertainty in a laboratory medicine is one of the most important factors for a reliable interpretation of the results. A large number of standards and guidelines indicate the need for a proper assessment of the uncertainty of measurement results in routine laboratory practice. The available documents gene rally recommend participation in the proficiency schemes/external quality control, as well as the internal quality control, in order to primarily verify the quality performance of the method. Although all documents meet the requirements of the International Standard, ISO 15189, the standard itself does not clearly define the method by which the measurement results need to be assessed and there is no harmonization in practice regarding to this. Also, the uncertainty of measurement results is the data relating to the measured result itself, but all factors that influence the interpretation of the measured value, which is ultimately used for diagnosis and monitoring of the patient's treatment, should be taken into account. So in laboratory medicine, an appropriate assessment of the uncertainty of the measurement results should have the ultimate goal of reducing diagnostic uncertainty. However, good professional laboratory practice and understanding analytical aspects of the test for each individual laboratory is necessary to adequately define the uncertainty of measurement results for specific laboratory tests, which helps to implement good clinical practice. Also, setting diagnoses in medicine is a decision with a certain degree of uncertainty, rather than statistically and mathematically calculated conclusion.
引用
收藏
页码:279 / 288
页数:10
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