Unification and validation of reference intervals – pilot study

Czech version

Authors: L. Šprongl ¹; H. Pláňková ¹; D. Stejskal ^2,3
Authors‘ workplace: Centrální laboratoř, Šumperská nemocnice a. s. ¹; Vědecko výzkumný institut Agel, pobočka Prostějov, Oddělení laboratorní medicíny Středomoravská nemocniční a. s. ²; Ústav lékařské chemie a biochemie, Lékařská fakulta, Univerzita Palackého Olomouc ³
Published in: Klin. Biochem. Metab., 22 (43), 2014, No. 3, p. 132-137

Overview

Objective:
To verify usefulness of reference intervals from the foreign study for their using in the laboratory network.

Material and Methods:
We used the data from NORIP study for the verification. We collected samples from the blood donors for our study, 100 males and 100 females. The analysis were provided in two hours after the collection with the standardized conditions (the same calibration and operator). We tested the following parametres: ALS, AST, ALP, GGT, Total bilirubin, Albumin, Urea, Uric acid, Creatinine, Potassium, Sodium and Calcium.

Results:
We verified for the tested measurands usefulness NORIP reference intervals in our laboratory network. The differences between or results and NORIP data were only in the percents.

Conclusion:
We recommend to use for the above mentioned parameters the reference intervals from the NORIP study.

Keywords:
reference intervals, decision limits, biological variability, reference population.

Sources

1. Rustad, P. et al. The Nordic Reference Interval Project 2000: recommended reference intervals for 25 common biochemical properties. Scand. J. Clin. Lab. Invest., 2004, 64, p. 271-84

2. Wootton, I., King, E., Smith, J. The quantitative approach to hospital biochemistry. Br. Med. Bull., 1951, 7, p. 307-11

3. Wootton, I. Individual variation. Proc. Nutr. Soc., 1962, 21, p. 129-35

4. Belk, W., Sunderman, F. A survey of chemical analyses in clinical laboratories by William P. Belk and F. William Sunderman, Arch. Pathol. Lab. Med., 1988, 112(4), p. 320-6

5. Hofman, R. Statistics in the practice of medicine, JAMA 1963, 185, p. 864-73

6. Murphy, E., Abbey, H. The normal range: A common misuse, J. Chronic. Dis. 1967, 20, p. 79-88

7. Sunderman, F. J. Current concepts of „normal values“, „reference values“ and „discrimination values in clinical chemistry, Clin. Chem., 1975, 25 (8), p. 1873-7

8. Grasbeck, R. et al. Provisional recomendation on theory of reference values. Part1. The concept of reference values. Clin. Chem., 1979, 25 (8), p. 1506-8

9. PetitClerc, C., Solberg, H. E. International Federation of Clinical Chemistry. Approved recomandation on theo-ry of reference values. J. Clin. Chem. Biochem., 1987, 25, p. 639-644

10. CLSI. How to Define and Determine Reference Intervals in the Clinical Laboratory. Approved Guideline – Se-cond Edition. CLSI documnet C28-A2. Wayne PA: CLSI, 2000

11. Ceriotti, F. Prerequisites for use of common reference intervals, Clin. Biochem. Rev., 2007, 28, p. 115-121

12. Ichihara, K., Boyd, J. C. An appraisal of statistical procedures used in derivation of reference intervals. Clin. Chem. Lab. Med., 2010, 48 (11), p. 1537-1551

13. Westgard, J. O. Basic Method Validation, Westgard QC, 2008, p. 177-186

14. Müller M. M. Implementation of reference systém in laboratory medicine. Clin. Chem. 2000, 46, s. 1907-9

15. Panteghini, M. Traceability, Reference Systems and Result Comparability. Clin. Biochem. Rev., 2007, 28, p. 97-104

16. www.bipm.org/jctlm/

17. Petersen, P. H., Jensen E. A., Branslund I. Analytical performance, reference values and decision limits. A need to differentiate between reference intervals and decision limits and to define analytical quality specifications. Clin. Chem. Lab. Med., 2012, 50 (5), p. 819-831

18. Hawkins, R. C., Badrick, T. Reference interval studies: what is the maximum number of samples recommen-ded? Clin. Chem. Lab. Med., 2013, 51 (11), p. 2161-2165

19. Henny, J. Multicenter reference interval studies: a pro-mising perspective for the future? Clin. Chem. Lab. Med., 2013, 51 (7), p. 1335-1338

20. Katayev, A., Balzica, C., Seccombe, D. W. Establishing reference intervals for clinical laboratory test results: is there a better way? Am. J. Clin. Pathol., 2010, 133 (2), p. 180-186

21. Panteghini, M., Ceriotti, F. Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is strategy? Clin. Chem. Lab. Med., 2012, 50 (5), p. 813-817

22. Siest, G., Henny, J., Gräsbeck, R. et al. The theory of reference values: an unfinished symphony. Clin. Chem. Lab. Med., 2013, 51 (1), p. 47-64

23. Plebani, M., Lippi, G. Reference values and the journal: why the past is now present. Clin. Chem. Lab. Med., 2012, 50 (5), p. 761-763

24. Yamamoto, I., Hosogaya, S., Osawa, S. et al. Nationwide multicenter study aimed to establishment of common reference intervals for standardized clinical laboratory tests in Japan. Clin. Chem. Lab. Med., 2013, 51 (8), p. 1663-1672

25. Ichihara, K., Ceriotti, F., Tam, T. H. Tha Asian project for collaborative derivation of reference intervals: strategy and major results of standardized analytes. Clin. Chem. Lab. Med., 2013, 51 (7), p. 1429-1442

26. Pineda-Tenor, D., Laserna-Mendieta, E. J., Timón-Zapata, J. et al. Biological variation and reference change values of common clinical chemistry and haematologic laboratory analytes in the elderly population. Clin. Chem. Lab. Med., 2013, 51 (4), p. 851-862

27. Hilsted, L., Rustad, P., Aksglaede, L., Sørensen, K., Juul A. Recommended Nordic paediatric reference intervals for 21 common biochemical properties. Scand. J. Clin. Lab. Invest., 2013, 73 (1), p. 1-9

28. Daly, Ch., Liu, X., Grey, V. K. L., Hamid, J. S. A systematic review of statistical methods used in constructing pediatric reference intervals. Clin. Biochem., 2013, 46 (13-14), p. 1220-1227

29. Shaw, J. L., Binesh-Marvasti, T., Colantiano, D., Adeli, K. Pediatric reference intervals: challenges and recent initiatives. Crit. Rev. Clin. Lab. Sci., 2013, 50 (2), p. 37-50

30. Friedecký, B., Šprongl, L., Kratochvíla, J., Plzák, Z. Doporučení k provádění validace a verifikace analy-tických metod v klinických laboratořích. Klin. Biochem. Metab., 2011, 19 (1), p. 36- 44

31. www.westgard.com

32. Burtis, C. A., Ashwood, E. R., Bruns, E.D. Tietz Textbook of Clinical Chemistry and Molecular Diagnostic, 2006, Elsevier Inc., St. Louis, ISBN 0-7216-0189-8

33. Soldin, J. S., Wong, E. C., Brugnara, C., Soldin, P.O. Pediatric Reference Intervals, 7th Edition, 2011, AACC Press, ISBN 9871594251017

34. Faulkner, R. W., Meites, S. Geriatric Clinical Chemistry, 1993, AACC Press, ISBN 9780915274659 Müller, M. M. Implementation of reference systém in laboratory medicine. Clin. Chem., 2000, 46, p. 1907-9

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Article was published in

Clinical Biochemistry and Metabolism

2014 Issue 3