title: Multicentre evaluation of KONE Optima analysis system.
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.
authors.affiliation: Istituto Scientifico HS Raffaele, Laboratorio Analisi, Milano, Italy. ferrero.carlo@hsr.it
authors.forename: C
authors.initials: C
authors.lastname: Ferrero
authors.forename: A
authors.initials: A
authors.lastname: Modenese
authors.forename: P A
authors.initials: PA
authors.lastname: Bonini
authors.forename: F
authors.initials: F
authors.lastname: Ceriotti
authors.forename: A
authors.initials: A
authors.lastname: Carobene
authors.forename: M
authors.initials: M
authors.lastname: Franzin
authors.forename: W G
authors.initials: WG
authors.lastname: Guder
authors.forename: W
authors.initials: W
authors.lastname: Hofmann
authors.forename: M
authors.initials: M
authors.lastname: Puukka
authors.forename: H
authors.initials: H
authors.lastname: Laitinen
authors.forename: V
authors.initials: V
authors.lastname: Makarovsky
authors.forename: N
authors.initials: N
authors.lastname: Gaidukova
mesh_terms: D001774:Blood Chemical Analysis / Q000295:instrumentation / Q000379:methods*; D001798:Blood Proteins / Q000032:analysis; D002784:Cholesterol / Q000097:blood; D003124:Colorimetry / Q000379:methods; D003404:Creatinine / Q000097:blood; D005060:Europe; D006801:Humans; D017736:Ion-Selective Electrodes; D008074:Lipoproteins / Q000097:blood; D015337:Multicenter Studies as Topic; D009391:Nephelometry and Turbidimetry / Q000379:methods; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014527:Uric Acid / Q000097:blood
chemical_list: D001798:Blood Proteins; D008074:Lipoproteins; D014527:Uric Acid; D002784:Cholesterol; D003404:Creatinine