engleski

Applicability of the recommended reference intervals for serum creatinine concentrations

Background. Due to the recent international requirement for accurate and specific diagnostic tests and implementation of calibration traceability to high-order reference measurement procedures and reference materials the aim of this study was to validate the applicability of the recommended “common” reference intervals for serum creatinine concentrations using specific enzymatic method to the Croatian population. Methods. The reference group comprised 120 males and 120 females aged between 18-74 years who were “a priori” selected in accordance with the approach proposed by the CLSI C28 document. Sera were frozen at -80 ºC until analyses. The Creatinine Enzymatic assay (Olympus OSR61204) standardized against IDMS method and Creatinine Jaffe Kinetic method (Olympus OSR6178) were used. Results. Method comparison between Creatinine Enzymatic (X) and Jaffe kinetic method (y) gave the following P/B equation for the whole group (n=240): y=1.00x +17.00 ; r=0.968. The obtained deviation between the specific und unspecific creatinine assays was in accordance with the previous publications. The reference intervals (central 95th percentiles) obtained with Creatinine Enzymatic assay ranged from 54 to 107 µmol/L for males and from 50 to 93 µmol/L for females vs. IFCC recommended reference intervals: 64 - 104 and 49 - 90 µmol/L for males and females, respectively. Conclusions. The comparability of the obtained results confirmed the applicability of the recently recommended “common” reference intervals by the IFCC Committee on Reference Intervals to the Croatian population for all laboratories measuring serum creatinie concentrations by enzymatic method traceable to the high-order reference measurement procedures.

calibration traceability; serum creatinie concentrations; enzymatic method

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