Impact of standardized calibration on the inter-assay variation of 14 automated assays for the measurement of creatinine in human serum.

Abstract:

PURPOSE:The aim of our study was to measure the inter-assay variation and accuracy of serum creatinine assays and to assess the effect of standardized calibration procedures on this variability. METHODS:We analyzed 30 human sera and three reference materials, using 17 creatinine assays (12 colorimetric, 4 enzymatic and 1 HPLC). We compared two standardized calibration procedures, using either a reference material or secondary standards, to that recommended by the manufacturers. RESULTS:For assays calibrated according to the manufacturers' recommendations, the median inter-assay coefficient of variation (CV) was 14.2% for 20 low samples (45-150 microM), and 7.7% for 10 high samples (250-350 microM). The CV was significantly influenced by the calibration procedure, but none of the standardized calibration procedures significantly improved the inter-assay variability. However, a significant decrease in CV was noted within each type of assay method (colorimetric or enzymatic) when the standardized calibration used standards of level(s) close to the concentrations to be measured. Only the compensated Jaffe technique and the amido-hydrolase assay showed bias of less than 10%. CONCLUSIONS:Standardizing calibration procedures is unlikely to decrease the analytical variability of creatinine assays enough to allow uniform and reliable use of the equations for estimation of glomerular filtration rate.

journal_name

Clin Chem Lab Med

authors

Séronie-Vivien S,Galteau MM,Carlier MC,Hadj-Aissa A,Hanser AM,Hym B,Marchal A,Michotey O,Pouteil-Noble C,Sternberg M,Perret-Liaudet A,Creatinine Working Group of the Société Française de Biologie Clinique.

doi

10.1515/CCLM.2005.213

keywords:

subject

Has Abstract

pub_date

2005-01-01 00:00:00

pages

1227-33

issue

11

eissn

1434-6621

issn

1437-4331

journal_volume

43

pub_type

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