Évaluation analytique et clinique des marqueurs tumoraux Vitros ECi™

Abstract

Tumor marker multicenter analytical and clinical evaluation with Vitros Eci. The Vitros ECi system and CEA, AFP, CA 15-3, CA 19-9 and CA 125II reagents have been evaluated in four different laboratories between february and november 2000. Within day precision is outstanding, within reagent lot, between reagent lot and even between laboratories precision are good, accuracy is very satisfying. Observed detection limits are much better than those quoted in the reagent pack leaflets and we have not observed any cross contamination or hook effect. Nine automatic dilution factors are offered by the system, the performance of which has been checked for all parameters. A normal patient population has been studied and reference values for Vitros ECi reagents have been redefined. The overall correlation versus Kryptor method was very satisfying for the five parameters. It is worth noting that CEA results and high CA 19-9 (> 100 kU · L −1) are significantly higher with Vitros ECi, and conversely very high CA 15-3 (> 1 000 kU · L −1) are significantly lower. Comparative kinetics are superimposable or parallel for the five parameters and numerical differences, that are sometimes important, do not disturb clinical interpretation. However, these differences might affect kinetic parameter (half time and doubling time) calculations. In addition to reliability, it is worth pointing out the convenience of the system, the easy use, and the excellent quality control management. According of all these properties, the Vitros ECi system is fully adapted and validated for these tumor marker assays.