Multicentre Evaluation of KONE Optima Analysis System

• Published in: Clinical chemistry and laboratory medicine Vol. 36; no. 7; pp. 475 - 484
• Main Authors: Ferrero, Carlo, Modenese, Annalisa, Bonini, Pier Angelo, Ceriotti, Ferruccio, Carobene, Anna, Franzin, Michela, Guder, Walter G., Hofmann, Walter, Puukka, Matti, Laitinen, Harri, Makarovsky, Vladimir, Gaidukova, Natalia, Lampinen, Hannu
• Format: Journal Article
• Language: English
• Published: Germany Walter de Gruyter 01.06.1998
• Subjects: Blood Chemical Analysis - instrumentation; Blood Chemical Analysis - methods; Blood Proteins - analysis; Cholesterol - blood; Colorimetry - methods; Creatinine - blood; Europe; Humans; Ion-Selective Electrodes; Lipoproteins - blood; Multicenter Studies as Topic; Nephelometry and Turbidimetry - methods; Reproducibility of Results; Sensitivity and Specificity; Uric Acid - blood; Europe
• ISSN: 1434-6621
• DOI: 10.1515/CCLM.1998.080

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 (γ-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 withinrun 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.