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Multicentre evaluation of KONE Optima analysis system

C Ferrero1, A Modenese, P A Bonini

  • 1Istituto Scientifico HS Raffaele, Laboratorio Analisi, Milano, Italy. ferrero.carlo@hsr.it

Clinical Chemistry and Laboratory Medicine
|September 24, 1998
PubMed
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The KONE Optima analyzer demonstrates good precision for various laboratory tests, including cholesterol and electrolytes. Accuracy is adequate, though some interferences were noted for creatinine and uric acid assays.

Area of Science:

  • Clinical chemistry
  • Laboratory diagnostics
  • Analytical instrumentation

Background:

  • The KONE Optima is a novel selective laboratory analyzer.
  • It performs turbidimetric, colorimetric, and ion-selective electrode measurements.

Purpose of the Study:

  • To evaluate the overall analytical performance of the KONE Optima analyzer and its reagents.
  • Assessment was conducted according to ECCLS guidelines in a multicenter study.

Main Methods:

  • A multicenter study involving four laboratories evaluated the Optima system.
  • Tests included substrates (cholesterol, HDL-cholesterol, creatinine), specific proteins (transferrin, IgG), enzyme activities (GGT, ALT), and electrolytes (Na, K, Cl).

Main Results:

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  • The system demonstrated good precision for all tested analytes, with within-run coefficients of variation (CV) ranging from 0.5% to 4.3% and between-day CVs from 0.8% to 7.9% (median across four labs).
  • Accuracy was generally adequate, with the exception of total cholesterol showing a 5% overestimation compared to the reference method.
  • Creatinine and uric acid assays experienced interference from bilirubin and hemoglobin, respectively (deviation >10%).

    • Conclusions:

    • The KONE Optima analyzer offers precise analytical performance for a range of clinical chemistry assays.
    • While generally accurate, potential interferences for specific analytes should be considered in clinical settings.