Harmonization, standardization, metrologic, succession in 2014. Principles, importance and data.
Authors:
B. Friedecký 1,2; J. Kratochvíla 1
Authors‘ workplace:
SEKK spol. s r o. Pardubice
1; ÚKBD, Fakultní nemocnice, Hradec Králové
2
Published in:
Klin. Biochem. Metab., 22 (43), 2014, No. 4, p. 177-183
Overview
Harmonization of laboratory results is necessary for approaching the clinical and economical effectiveness in laboratory examinations and also to reduction of patients risk in diagnostic and therapeutic processess due to measurement errors. Harmonization of results in clinical laboratories is based on the standardization of measurement methods and standardization is realized by traceability chains from reference procedures and certified reference materials to calibration of routine methods. The main goal of harmonization is establishment of commonly valid values of reference intervals and/or diagnostic decision limit, values independent on the used measurement nethods and location of laboratories. Communication introduces describing data on the harmonization, produced namely by IFCC, JCTLM, NIST, IRMM-EU. We also deal with Stockholm quality declaration, with the narrow spectrum of harmonized methods, and with the lack of suitable level of working documentation provided by producers of diagnostics.
Keywords:
Standardization, traceability, standardization, reference procedures, reference materials, producers of diagnostics.
Sources
1. Beastall, G. H. Adding value to laboratory medicine: a professional responsibility. Clin. Chem. Lab. Med., 2013, 51, p. 221-227.
2. Wible, B., Mervis, J., Wigginton, N. S. Rethinking the global supply chains. Science, June 2014, p. 1000-1003.
3. Gillery, P., Young, I. S. Progress towards standardization: an IFCC Scientific Division Perspective. Clin. Chem. Lab. Med., 2013, 51/5, p. 915-917.
4. Miller, W. G., Tate, J. R., Barth, J. H., Jones, G. R. D. Harmonization: the sample, the measurement, and the report. Ann. Lab. Med., 2014, 34, p. 187-197.
5. Braga, F., Panteghini, M. Verification of in vitro medical diagnostics (IVD) metrological traceability: Responsibilities and strategies. Clin. Chim. Acta, 2014, 432, p. 55-61.
6. Sikaris, K. Application of the Stockholm Hierarchy to Defining the Quality of Reference Intervals and Clinical Decision Limits. Clin. Biochem. Rev., 2012, 33, p. 141-148.
7. Lieske, J. C., Bondar, O., Miller, G. W., Bachmann, L. M., Narva, A. S., Itoh, Y. et al. A reference system for urinary albumin: current status. Clin. Chem. Lab. Med., 2013, 51, p. 981-990.
8. Bais, R., Armbruster, D., Jansen, R. T. P., Klee, G., Panteghini, M. et al. Defining acceptable limits for the metrological traceability of specific measurands. Clin. Chem. Lab. Med., 2013, 51, p. 973-979.
9. Siekmann, L. Metrological traceability. A concept for standardization in laboratory medicine. Clin. Chem. Lab. Med., 2013, 51, p. 953-957.
10. Tirimacco, R., Koumantakis, G., Erasmus, R., Mosca, A., Sandberg, S., Watson, I. D. et al. Glucose meters - fit for clinical purpose. Clin. Chem. Lab. Med., 2013, 51, p. 943-952.
11. Hanas, R., John, W. G. 2013 update on the worldwide standardization of the hemoglobin A1c measurement. Clin. Chem. Lab. Med., 2013, 51, p. 1041-1043.
12. Sturgeon, C. M., Sprangue, S. H., Metcalfe, W. Variation in parathyroid hormone immunoassays results - a clinical governance issue in the management of chronic kidney disease. Nephrol. Dial. Transplant., 2011, 26, p. 3440-3445.
13. Couchman, L., Taylor, D. R., Krastins, B., Lopez, M. F., Monitz, C. F. et al. LC-MS candidate reference methods for the harmonization of parathyroid hormone (PTH) measurement: a rewiew of recent developments and future considerations. Clin. Chem. Lab. Med., 2014. DOI:101515/cclm-2014-0150.
14. Lehmann, S., Hoofnagle, A., Hochstrasser, D., Brede, C., Glueckmann, M. et al. Quantitative Clinical Chemistry Proteomics (qCCP) using mass spectrometry: general characteristics and application. Clin. Chem. Lab. Med., 2013, 51, p. 919-935.
15. Kessler, A., Siekmann, L., Weykamp, C., Geilenkeuser, W. J., Dreazen, O., Middle, J., Schumann, G. External Quality Assessment Scheme for reference Laboratories - rewiews of 8 years experience. Clin. Chem. Lab. Med., 2013, 51, p. 997-1005.
16. Ozarda, Y., Ichihara, K., Barth, J. H., Klee, G. Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values. Clin. Chem. Lab. Med., 2013, 51, p. 1027-1040.
17. Grubb, A., Blirup-Jensen, S., Lindstroem, V., Schmidt, C., Althaus, H., Zegers, I. First certified reference material for cystatin C in human serum ERM-DA471/IFCC. Clin. Chem. Lab. Med., 2010, 48, p. 1619-1621.
18. Grubb, A., Horio, M., Hansson, L. O., Bjoerk, J., Nyman, U., Flandin, M. et al. Generation of a new cystatin C-based estimating equation for glomerular filtration rate by use of 7 assays standardized to the international calibrator. Clin. Chem., 2014. E pub ahead print.
19. Jeppsson, J. O., Kobolt, U., Barr, J., Finke, A., Hoelzel, W., Hoshino, T. et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin. Chem. Lab. Med., 2002, 40/1, p. 78-89.
20. Hanas, R., John, G. 2010 consensus statement on the worldwide standardization of the hemoglobin A1c measurement. Diabetes Care, 2010, 33, p. 1903-1904.
21. Tietz, N. W., Burtis, C. A., Duncan, P., Ervin, K., Petitclerc, C. J., Rinker, A. D. et al. A reference method for measurement of alkaline phosphatase activity in human serum. Clin. Chem., 1983, 29, p. 751-761.
22. Schumann, G., Klauke, R., Canallias, F., Bossert-Reuther, S., Franck, P. F. H., Gella, F. J. et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37˚C. Part 9: Reference procedure for the measurement of catalytic concentration of alkaline phosphatase. Clin. Chem. Lab. Med., 2011, 49, p. 1439-1446.
23. Schumann, G., Aoki, R., Ferrero, C. A., Ehlers, G., Férard, G., Gella, F. J. et al. IFCC primary reference procedures for the measurement of catalytic concentrations of enzymes at 37 degrees C. Part 8. Reference procedure for the measurement of catalytic concentration of α-amylase. Clin. Chem. Lab. Med., 2006, 44, p. 1146-1155.
24. Canalias, F., Garcia, E., Sanchez, M. Metrological traceability of values for alpha-amylase catalytic concentration assigned to a commutable calibrator materials. Clin. Chim. Acta, 2010, 411, p. 7-12.
25. Greenberg, N., Roberts, W. L., Bachmann, L. M., Whight, E. C., Dalton, R. N. et al. Specificity characteristics of 7 cpommercial creatinine measurement procedures by enzymatic and Jaffe method principles. Clin. Chem., 2012, 58, p. 391-401
26. Hermida, F. J., Lorenzo, M. J., Perez, A., Fernandez, M., Sogastiora, O., Magadan, C. Comparison between ADVIA enzymatic creatinine method and ADVIA creatinine kinetic Jaffe method for determining creatinine. Scand. J Clin. Lab. Invest, 2014 DOI 103109/00365513. 2014. 928943.
27. Cerriotti, F., Hinzmann, R., Panteghini, M. Reference intervals: the way forward. Ann. Clin. Biochem., 2009, 46, p. 8-17.
28. Rustad, P., Felding, P., Franzson, L., Kairisto, A., Lahti, A., Martenson, A. et al. The nordic reference interval project 2000: recommmended reference intervals for 25 common biochemical properties. Scand. J Clin. Lab. Invest, 2004, 64, p. 271-284.
29. Ichihara, K., Cerriotti, F., Tam, T. H., Suyehoshi, S., Poon, P. M. K., Thong, M. L. et al. The Asian pro-ject for collaboratove derivation of reference intervals: (1) strategy and major results of standardized analytes. Clin. Chem. Lab. Med., 2013, 51, p. 1429-1442.
30. Yamamoto, Y., Hosogaya, S., Osawa, S., Ichihara, K., Onuma, T., Saito, A. et al. Nationalwide multicenter study aimed at the establishment of common reference intervals for standardized clinical laboratory tests in Japan. Clin. Chem. Lab. Med., 2013. 51, p. 1663-1672.
31. Stepman, H. C. M., Stöckl, D., Ademe, R., Sesini, S., Mazziotta, D., Thienpont, L. M. Status of serum calcium and albumin measurement in Argentina assessed in 300 representative laboratories with 20 fresh frozen single donation sera. Clin. Chem. Lab. Med., 2011, 49, p. 1829-1836.
32. Myers, G. L. Standardization of creatinine: finally achieved? 7th CIRME International Scientific Meeting 2013, Stresa Italy.
Labels
Clinical biochemistry Nuclear medicine Nutritive therapistArticle was published in
Clinical Biochemistry and Metabolism
2014 Issue 4
Most read in this issue
- Refeeding syndrome – pathobiochemistry, electrolyte dysbalances and their correction
- Role of oxidative stress in Alzheimer´s disease and related consequences
- Liver Iron and Copper Assessment in Bioptic Material from Patients with Different Hepatic Pathology – Diagnostic Significance and Relationship to Serum Iron and Copper Parameters
- Harmonization, standardization, metrologic, succession in 2014. Principles, importance and data.