title: [Results transferability on RXL, ARX, X-Pand, BN2 (Dade Behring) and modular DP (Roche Diagnostics) analysers: application to component assays of fibrotest and Actitest].
abstract: The follow up of patients with chronic liver diseases and the data from multicentric clinical studies are affected by the variability of assay results for the same parameter between the different laboratories. Today, the main objective in clinical chemistry throughout the world is to harmonise the assay results between the laboratories after the confirmation of their traceability, in relation to defined reference systems. In this context, the purpose of our study was to verify the homogeneity of haptoglobin, apolipoprotein A1, total bilirubin, GGT activity, ALAT activity results, which are combined in Fibrotest and Actitest, between Dimension Analysers RXL, ARX and X-PAND (Dade Behring Society). Moreover, we verified the transferability of Fibrotest and Actitest results between the RXL, and either the BN2 (haptoglobin and apolipoprotein A1) or the Modular DP (total bilirubin, GGT and ALAT activity concentrations). The serum samples from 150 hospitalised patients were analysed on the different analysers. Specific protein assays were calibrated using solutions standardised against reference material on Dimension and BN2 analysers. Total bilirubin assays were performed by a diazoreaction on Dimension and Modular DP analysers. The GGT and ALAT activity measurements on the Dimension analysers were performed in accordance with the reference methods defined by the International Federation of Clinical Chemisty and Laboratory Medicine (IFCC). On the Modular, enzyme activity measurements were performed according to the Szasz method (L-gamma- glutamyl-4-nitroanilide as substrate) modified by Persijn and van der Slik (L-gamma- glutamyl-3-carboxy- 4-nitroanilide as substrat) for GGT and according to the IFCC specifications for ALAT. The methods of enzymatic activity measurement were calibrated on the Modular only. Liver fibrosis and necroinflammatory activity indices were determined using calculation algorithms, after having adjusted each component's result of Fibrotest and Actitest for gender and age. Our study has shown, for each parameter, harmonious results between the Dimension analysers and between RXL and BN2- Modular DP. Disregarding alpha-2 macroglobulin which cannot be assayed on RXL, the results of Fibrotest and Actitest were similar as performed on BN2- Modular DP and RXL.
authors.affiliation: Service de biochimie, Hôpital de la Salpêtrière, Paris. Fimbis@aol.com
authors.forename: F
authors.initials: F
authors.lastname: Imbert-Bismut
authors.forename: D
authors.initials: D
authors.lastname: Messous
authors.forename: A
authors.initials: A
authors.lastname: Raoult
authors.forename: T
authors.initials: T
authors.lastname: Poynard
authors.forename: J J
authors.initials: JJ
authors.lastname: Bertrand
authors.forename: P A
authors.initials: PA
authors.lastname: Marie
authors.forename: V
authors.initials: V
authors.lastname: Louis
authors.forename: C
authors.initials: C
authors.lastname: Audy
authors.forename: J M
authors.initials: JM
authors.lastname: Thouy
authors.forename: B
authors.initials: B
authors.lastname: Hainque
authors.forename: A
authors.initials: A
authors.lastname: Piton
mesh_terms: D001774:Blood Chemical Analysis / Q000379:methods* / Q000592:standards*; D006403:Hematologic Tests / Q000379:methods* / Q000592:standards*; D006801:Humans; D012015:Reference Standards