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Multicentre evaluation of KONE Optima analysis system.

作者信息

Ferrero C, Modenese A, Bonini P A, Ceriotti F, Carobene A, Franzin M, Guder W G, Hofmann W, Puukka M, Laitinen H, Makarovsky V, Gaidukova N

机构信息

Istituto Scientifico HS Raffaele, Laboratorio Analisi, Milano, Italy.

出版信息

Clin Chem Lab Med. 1998 Jun;36(7):475-84. doi: 10.1515/CCLM.1998.080.

Abstract

Optima from KONE Instruments Corporation is a new selective laboratory analyzer for turbidimetric, colorimetric and ion selective electrode measurements. Overall analytical performance of Optima and reagents provided by KONE was evaluated according to ECCLS guidelines, in a multicentre study involving four different laboratories, including substrates (cholesterol, high-density lipoprotein-cholesterol, creatinine), specific proteins (transferrin, IgG), enzyme activities (gamma-glutamyltransferase, alanine aminotransferase) and electrolytes (sodium, potassium, chloride). The results obtained attest good precision of the system for all the analytes tested: the range of within-run CV is 0.5 %-4.3 %, and range of between-day CV % is 0.8 %-7.9 % (median of four laboratories). Except for total cholesterol (5 % overestimation compared to the reference method) accuracy of measurement is adequate. Creatinine and uric acid assays were subjects of interference (defined as deviation > 10 % from target value) by bilirubin and haemoglobin respectively.

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