Calculation of measurement uncertainty of 20 Clinical Chemistry Analytes according to the practical ISO approach

Authors : Abdülkadir ÇAT, Kamil Taha UÇAR

Pages : 1-9

Doi:10.31067/acusaglik.1174521

View : 37 | Download : 19

Publication Date : 2023-01-01

Article Type : Research Paper

Abstract :Purpose: Measurement Uncertainty insert ignore into journalissuearticles values(MU); is a valuable tool for evaluating analytical performance and interpreting results in clinical laboratories. The International Organization for Standardization insert ignore into journalissuearticles values(ISO); has proposed a practical approach for MU calculation in its ISO/TS 20914:2019 guide. This study aimed to calculate the MU values of 20 clinical chemistry analyses per the ISO guideline and compare them with the Maximum expanded allowable measurement uncertainty insert ignore into journalissuearticles values(MAU); values. Methods: The study was performed using 6-month internal quality control insert ignore into journalissuearticles values(IQC); values insert ignore into journalissuearticles values(uRw); and calibrator uncertainty insert ignore into journalissuearticles values(ucal); in line with the recommendations of the ISO/TS 20914:2019 guideline. The common MU value was calculated for 20 clinical chemistry tests on two identical devices, Roche Cobas 6000 c501 insert ignore into journalissuearticles values(Roche Diagnostics, Mannheim, Germany); analyzers. The calculated MU values for the tests were compared with the current MAU values in the European Federation of Clinical Chemistry and Laboratory Medicine insert ignore into journalissuearticles values(EFLM); Biological Variation database insert ignore into journalissuearticles values(the current Clinical Laboratory Improvement Amendments/CLIA recommendation for Ethanol has been selected);. Results: MU values for Alanine aminotransferase, C-reactive Protein, Iron, Ethanol, Total Bilirubin, Triglyceride, and Blood urea nitrogen remained within the MAU limits. The MU values of the other 13 tests insert ignore into journalissuearticles values(excluding Aspartate aminotransferase, Glucose, and Potassium Level 2 IQC); exceeded the MAU values. Conclusion: It was observed that the uRw value affected the MU value the most. Close monitoring and evaluation of uRw and thus IQC and implementation of corrective and preventive actions may reduce MU.
Keywords : Measurement uncertainty, internal quality control, quality management, laboratory medicine, clinical chemistry