Harmonization in the clinical laboratory and the nature of external quality assessment in the near future.

Česká verzia

Authors: B. Friedecký ¹; J. Kratochvíla ²; A. Jabor ³
Authors place of work: ÚKBD FN Hradec Králové ¹; SEKK spol. s r. o., Pardubice ²; OKB, PLM, IKEM Praha ³
Published in the journal: Klin. Biochem. Metab., 30, 2022, No. 2, p. 32-36

Summary

In vitro device diagnostics requirements (IVDR 746), harmonization of results, realized by metrological traceability of calibration are the main fields of next development in laboratory medicine. Corresponding face of external quality assurance programs (EQA) are here briefly described. We deal with problems of commutability of control materials and also with analytical performance specification values (APS). The role of biological variation introduced in EuBIVAS database is also briefly mentioned Problems of using the non-commutable control materials should be solved intensively too. The necessity of stepwise development EQA is clear and leads via commutability control materials and well determined analytical performance values.

Keywords:

harmonization – commutability – IVDR 746 – Metrological traceablity – analytical performance specification – external quality assurance

Zdroje

1. ČSN EN ISO 17511:2020 In vitro diagnostics medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples.

2. ČSN ISO 21151:2021 IVD MD Measurement of quantities in samples of biological origin. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples.

3. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5. April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Official Journal of the European Union 2017; May 5.: L 117/L 176.

4. Myers, G. L., Pierson-Perry, J., Beastell, G. H. The European Union In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR): overview and implications for the future of laboratory medicine. eNews-IFCC, 2019, 1, s. 20-24.

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6. Nilsson, G., Budd, J. R., Greenberg, N., Delatour, V., Rej, R. et al. IFCC working group for assessing commutability. Part 2: Using the Difference in Bias Between a Reference Material and Clinical Samples. Clin. Chem., 2018, 64(3), s. 455-464.

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8. Sandberg, S., Fraser, C. G., Horvath, A. R., Jansen, R., Jones, G. Et al. Defining analytical performance specifications consensus statement from the 1st strategic conference of the European federation of clinical chemistry and laboratory medicine. Clin. Chem. Lab. Med., 2015, 53, s. 833-835.

9. Carobene, A., Aarsand, A. K., Barlett, W. A., Coskun, A., Diaz-Garzon, J. et al. The European biological variation study (EuBIVAS): a summary report. Clin. Cherm. Lab. Med., 2021, https://doi.org/10.1515/cclm- 2021-0370.

10. Badrick, T., Miller, G. W., Panteghini, M., Delatour, V., Berhall, H., MacKenzie, F. et al. Interpreting EQA- -Understandaing Why Commutability of Materials Matter. Clin. Chem., 2022, doi: 10.1093/clinchem/hvac002.

11. Jones, G. R. D., Delatour, V., Badrick, T. Metrological traceability and clinical traceability of laboratory results - the role of commutability in external quaity assurance. Clin. Chem. Lab. Med., 2022, https://doi.org/10.1515/ cclm-2022-0038.

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