The impact of metrological traceability on the validity of creatinine measurement as an index of renal function

When the calibration of a routine measurement procedure is traced back to metrological higher order, a significant discrepancy can occur between the analytical conditions of the routine measurement and the analytical conditions that were used in the clinical studies upon which the decision-making criteria are based. This can lead to serious interpretation errors with possible dramatic consequences for patients. The calibration of the creatinine Jaffé method is an excellent example of the importance of medical traceability. The compensated Jaffé method correlated accurately with the reference method and the compensated Jaffé creatinine clearance (CrCl), Cockroft and Gault and MDRD with the ⁵¹Cr EDTA clearance. The Schwartz estimate based upon the compensated Jaffé and enzymatic method overestimated, while uncompensated Jaffé slightly underestimated glomerular filtration rate (GFR). The situation in children is complex since serum creatinine concentrations are much lower in infants, rendering tubular secretion relatively more important. Low-molecular weight proteins have been suggested to replace serum creatinine as a marker for GFR. -trace protein, cystatin C, and ₂-microglobulin showed good correlation with GFR. However, care should be taken in patients presenting with some malignant tumors, since significant increases of cystatin C in patients with metastatic melanoma or colorectal cancer has been reported.Presented at the 9th Conference on Quality in the Spotlight, 18-19 March 2004, Antwerp, Belgium