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Related Experiment Videos

Multicentre evaluation of the Bayer DAX system

L Morosini1, M Rossetti, P Berti

  • 1Servizio Chimica e Microscopia Clinica, Stabilimento Ospedaliero di Pordenone.

European Journal of Clinical Chemistry and Clinical Biochemistry : Journal of the Forum of European Clinical Chemistry Societies
|December 1, 1993
PubMed
Summary

The DAX analyser demonstrates excellent analytical performance, meeting stringent clinical chemistry standards for imprecision and inaccuracy. This high-throughput random access analyser is highly suitable for routine use in hospitals.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Analytical Performance Evaluation

Background:

  • The DAX is a high-throughput random access analyser used in clinical laboratories.
  • Evaluating analytical instruments is crucial for ensuring reliable patient results.
  • Multicenter evaluations provide robust data on instrument performance under varied conditions.

Purpose of the Study:

  • To assess the analytical performance of the DAX analyser according to established guidelines.
  • To evaluate the imprecision, inaccuracy, linearity, and interferences of the DAX system.
  • To determine the suitability of the DAX for routine use in clinical laboratories.

Main Methods:

  • A multicenter evaluation involving four laboratories over four months.

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  • Analysis of 12 analytes with over 60,000 data points.
  • Imprecision studies using control sera and patient samples.
  • Method comparison, linearity testing, and interference studies.

    • Main Results:

    • Within-run and between-day imprecision (CV) were consistently low, generally below 3%.
    • Manufacturer claims for linearity were met or exceeded, with good recovery rates (94-106%).
    • Interferences were predictable, except for alpha-amylase affected by bilirubin and hemolysis; overall performance met SFBC, DGKC, and Fraser et al. acceptance limits.

    Conclusions:

    • The DAX analyser exhibits high productivity and reliability.
    • Its analytical performance is well within acceptable limits for routine clinical laboratory use.
    • The DAX is highly suitable for medium to large hospitals due to its performance and ease of use.