Reference intervals for plasma cystatin C and plasma creatinine in adults using methods traceable to international calibrators and reference methods.

Introduction: The aim of this study was to establish reference intervals for plasma cystatin C and creatinine in adults using the Gentians cystatin C method traceable to the international calibrator standard ERM-DA471/IFCC and a creatinine method traceable to the IDMS (Isotope Dilution Mass Spectrometry) creatinine reference method.

Methods: Blood samples were collected from 304 healthy blood donors (152 men and 152 women between 17 and 66 years old) with 30-31 men and 30-31 women in each ten-year interval. Plasma cystatin C was analyzed using the Gentian Cystatin C assay on a Roche cobas c702 analyzer, and plasma creatinine was analyzed using the CREA Plus assay on the Roche Modular P analyzer.

Results: The nonparametric reference intervals for plasma cystatin C were 0.58-1.00 mg/L in women (median 0.78 mg/L, range 0.56-1.06 mg/L) and 0.62-1.04 mg/L in men (median 0.79 mg/L, range 0.61-1.07 mg/L). The Mann-Whitney U test revealed no gender-related difference in plasma cystatin C (P = .21). A common reference interval in women and men was calculated to be 0.61-1.01 mg/L (median 0.79 mg/L, range 0.56-1.07 mg/L). The nonparametric reference interval for plasma creatinine was 52-89 μmol/L in women (median 69 μmol/L, range 52-92 μmol/L) and 61-108 μmol/L in men (median 86 μmol/L, range 56-118 μmol/L). The Mann-Whitney U test revealed a gender-related difference in plasma creatinine (P < .0001).

Conclusion: In conclusion, we have established reference intervals for plasma cystatin C and creatinine in adults using methods traceable to international standards.