Measurement uncertainty and error in medical laboratories


Authors: B. Friedecký 1;  J. Kratochvíla 2
Authors‘ workplace: Ústav klinické biochemie a diagnostiky Fakultní nemocnice Hradec Králové 1;  SEKK Pardubice 2
Published in: Klin. Biochem. Metab., 27, 2019, No. 1, p. 25-31

Overview

In our presentation we deal with some recent points of view on the problems of uncertainty measurement in clinical laboratories. Our presentation discusses questions about the differences between uncertainties and total error of measurements. We introduce crucial links among uncertainty and, analytical performance specification of EQAS, biological variation, reference change values and reference intervals. We also introduce relations of uncertainty to metrological traceability and harmonization processes and problems uncertainty calculation in methods with the lack of standardization and harmonization. Also, performance of calculation measurement uncertainty from internal quality and external assessment data are presented.

Keywords:

Measurement uncertainty – EQAS – IQC – total error – RCV – reference interval – bias


Sources

1. TNI 01 0115:2009: Mezinárodní metrologický slovník - Základní a všeobecné pojmy a přidružené termíny (VIM 3, UNMZ 2009).

2. ČSN EN ISO/IEC 17025:2018 Všeobecné požadavky na kompetenci zkušebních a kalibračních laboratoří. ČAS 2018.

3. ČSN EN ISO 15189 ed. 2: 2013. Zdravotnické laboratoře - Požadavky na kvalitu a způsobilost. ČAS 2013.

4. Guide to the Expression of Uncertainty in Measurement (GUM). ISO, Geneva 1995, ISBN 92-67-10188-9, v roce 2008 znovu vydán s nepodstatnými změnami jako ISO/IEC Guide 98-3:2008, český překlad TNI 01 4109-3:2011 Nejistoty měření – Část 3: Pokyn pro vyjádření nejistoty měření (GUM:1995).

5. Farrance, I., Badrick, T., Frenkel, R.: Uncertainty in measurement and total error: different roads to the same quality destination? Clin. Chem. Lab. Med., 2018, 56/12, 2010-2014.

6. Westgard, J. O., Westgard, S. A.: Measuring analytical quality. Total analytical error versus measurement uncertainty. Clin. Lab. Med., 2017, 37, 1-13.

7. Oosterhuijs, W. P., Bayat, H., Ambruster, D., Coskun, A., Freeman, K. P., Kallner, A. The use of error and uncertainty methods in medical laboratory. Clin. Chem. Lab. Med., 2018, 56/2, 209-219.

8. The EurA1c Trial Group: EurA1c: the European HbA1c Trial to Investigate the Performance of HbA1c Assays in 2166 Laboratories across 17 Countries and 24 Manufacturers by Use of the IFCC Model for Quality Targets. Clin Chem 2018, 64/8:1183-1192.

9. Weykamp, C., Secchiero, S., Plebani, M., Thelen, M., Cobbaert, C., Thomas, A. Analytical performance of 17 general chemistry analytes across countries and across manufacturers with INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain. Clin. Chem. Lab. Med., 2016, 55, 203-211.

10. Farrance, I., Badrick, T., Frenkel, R. Uncertainty in measurement: A review of the procedures for determining uncertainty in measurement and its use in deriving the biological variation of the estimated glomerular filtration rate. Pract. Lab. Med., 2018, 12, e00097.

11. Kalkulátor nejistot pro zdravotnické laboratoře. Dostupné na: www.sekk.cz/infoservis/2014_nejistoty_doporuceni.pdf

12. Synek, V. How to encompass an uncorrected bias into the expanded uncertainty with a fixed coverage probabi-lity: calculation procedures. Accred. Qual. Assur., 2017, 2/4, 179-186.

13. Synek, V., Plzák, Z. Odhad nejistoty chemických měření se započtením vychýlení. Metodický list 16. Eurachem ČR 2017. Dostupné na www.eurachem.cz

14. Magnusson, B., Ellison, S. L. R. Treatment of uncorrected bias in uncertainty estimation for chemical measurements. Anal. Bioanal. Chem., 2008, 390, 201 – 213.

15. Infusino, I., Panteghini, M. Measurement uncertainty: friend or foe? Clin. Biochem., 2018, 57, 3-6.

16. Braga, F., Infusino, I., Panteghini, M. Performance criteria for combined uncertainty budget in the implementation of metrological traceability.Clin. Chem. Lab. Med., 2015, 53, 905-912.

17. Braga, F., Panteghini, M. Defining permissible limits for the combined uncertainty budget in the implementation of metrological traceability. Clin. Biochem., 2018, 57, 7-11.

18. ISO FDIS 17511:2019. In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. ISO Geneve (TC 212).

19. Padoan, A., Sciacoveli, L., Aika, A., Antonelli, G., Plebani, M. Measurement uncertainty in laboratory reports: A tool for improving the interpretation of test results. Clin. Biochem., 2018, 57, 41-47.

20. Aarsand, A. K., Diaz-Garzón, J., Fernandéz-Calle, P., Guerra, E., Locatelli, M. The EuBIVAS: within and between-subject biological variation data for electrolytes, lipids, urea, uric acid, total protein, total bilirubin, direct bilirubin and glucose. Clin. Chem., 2018, 64/9, 1380-1393.

21. Carobene, A., Roraas, T., Solvik, U., Sylte, M. S., Sandberg, S., Guerra, E. Biological variation estimates obtained from 91 healthy study participants for 9 enzymes in serum. Clin. Chem., 2017, 63, 1141-1150.

22. Carobene, A., Marino, I., Coskum, A., Serteser, M., Unsal, I., Guerra, E. The EuBivas project within- and between- subject biological variation data for serum creatinine using enzymatic and alkaline picrate methods and implications for monitoring. Clin. Chem., 2017, 63/9, 1527-1536.

23. Sandberg, S., Fraser, C. G., Horvath, A. R., Jansen, R., Jones, G., Oosterhuis, W. Defining analytical performance specification: Consensus statement from the 1st strategic conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin. Chem. Lab. Med., 2015, 53, 833-836.

24. Qin, Y., Zhou, R., Wang, W., Yin, H., Yang, Y., Yue, Y. Uncertainty evaluation in clinical chemistry, immunoassay, hematology and coagulation analytes using only external quality assessment data. Clin. Chem. Lab. Med., 2018, 56/9, 1447-1457.

25. Beck, S. C., Lock, R. J. Uncertainty of measurement: an immunology laboratory perspective. Ann. Clin. Biochem., 2015, 52, 7-17.

Labels
Clinical biochemistry Nuclear medicine Nutritive therapist
Login
Forgotten password

Don‘t have an account?  Create new account

Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account