A comparison between ALP catalytic concentrations determined by the routine ALP measurement (Roche Diagnostics) and those obtained by the alkaline phosphatase approach (BLW Diagnostics

Česká verze

Authors: H. Dobrovolná ¹; V. Soška ^1,2,3
Authors place of work: Oddělení klinické biochemie, Fakultní nemocnice u sv. Anny v Brně ¹; ICRC - oddělení kardiovaskulárních chorob, Fakultní nemocnice u sv. Anny v Brně ²; Katedra laboratorních metod, Lékařská fakulta MU Brno ³
Published in the journal: Klin. Biochem. Metab., 24, 2016, No. 4, p. 173-178

Summary

Objective:
The aim of the study was to compare the results of ALP catalytic concentration in serum and plasma determined by the routine ALP method (Roche Diagnostics), with the results of those determined by the alkaline phosphatase approach (BLW Diagnostics), after the IFCC reference method 2011. Assessment was made of the influence of standardization for ALP determination on results in patient samples.

Setting:
Department of Clinical Biochemistry, St. Anne’s University Hospital (FNUSA), Brno.

Material and Methods:
Single samples were taken from a set of 135 patients examined in FNUSA. The ALP catalytic concentration was determined by the routine ALP method (Roche Diagnostics) on a Modular P analyzer and by the Alkaline phosphatase method (BLW Diagnostics) on a Cobas c311 analyzer. The null hypothesis was that the mean difference between the ALP results compared would not be significantly different from zero in statistical terms. The ALP results were evaluated by paired samples t-test, by Wilcoxon test and by variance ratio test (F-test).

Results:
In a group of 135 men and women the mean difference between ALP values determined was statistically significantly different between the results of Roche and BLW methods. The mean difference between ALP_BLW and ALP_Roche was 0.58 μkat/l. The mean value of ALP_Roche was 3.036 µkat/l, 95%CI (2.165 –⁠ 3.906 µkat/l). The mean value of ALP_BLW was 3.615 µkat/l, 95%CI (2.563 –⁠ 4.666 µkat/l). Results that were significantly different in terms of exceeding the upper reference limits in ALP_Roche and ALP_BLW appeared in 12% of the female part of the group and 17% in the male part.

Conclusion:
ALP results determined by the Roche and BLW methods may be different, judged in terms of exceeding upper reference limits for ALP.

Keywords:
Alkaline phosphatase, reference method, routine method, reference interval.

Zdroje

1. Sedlák, P., Fridecký, B., Kratochvíla, J., Budina, M. Stav standardizace stanovení katalytické koncentrace alkalické fosfatázy z pohledu různých programů externích hodnocení kvality. Názor na situaci a její řešení. Klin. Biochem. Metab., 2015, roč. 23(44), č. 1, s. 21-26.

2. Dostupné na webové adrese: http://www.sekk.cz/ ke dni 4. 3. 2016.

3. Tietz, N. W., Burtis, C. A., Duncan, P., Ervin, K., Petitclerc, C. J., Rinker, A. D. at al. A reference method for measurement of alkaline phosphatase aktivity in human serum. Clin. Chem., 1983, 29, 751 -⁠ 761.

4. Schumann, G., Klauke, R., Canalias, 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 ºC. Part 9: Reference procedure for the measurement of catalytic concentration of alkaline phosphatase. Clin. Chem. Lab. Med., 2011, 49, s. 1439-1446.

5. Abicht, K., El-Samalouti, V., Junge, W. et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 ºC reference intervals. Clin. Chem. Lab. Med., 2001, 39, Special supplement pp S346.

6. Chromý, V., Zahradníček, L., Vozníček, J. Use of N-methyl-D-glucamine as Buffer in the Determination of Serum Alkaline Phosphatase Activity. Clin. Chem., 1981, 27, 1729 -⁠ 1732.

7. http://www.bipm.org/en/committees/jc/jctlm/

8. Příbalová informace DG-CAL CALIBRATOR, REF DGQ06.1, BLW Diagnostics, 2015-08-15.

9. Příbalová informace Kalibrátor alkalická fosfatáza_2 (ALP_2), REF 10916060, Siemens, 2015-06

10. Han, L., Wang, J., Li, Y., Zhang, Q., Zheng, S., Lin, H. et al. Application of New Reference Procedure for ALP Measurement in the Clinical Laboratory. Clin. Lab., 2015, 61, s. 445-452.

11. Han, L., Wang, J., Li, Y., Zhang, Q., Ke, P., Wu, X. et al. Development of reference intervals for serum alkaline phosphatase among adults in Southern China traced to the new IFCC reference measurement procedure. Clin. Chem. Lab. Med., 2015, aop cclm-2015-0732.

12. Fridecký, B., Kratochvíla, J. Aktuální stav standardizace měření katalytických koncentrací enzymů a srovnatelnosti výsledků. Minireview. Klin. Biochem. Metab., 2015, roč. 23(44), č. 4, s. 165-170.

13. Sedlák, P., Fridecký, B., Kratochvíla, J. Experimenty s referenční metodou ALP IFCC 2011. Fons, 2015, č. 1, s. 17-19.