ORDA - Online Research Data Archive 
    • Login
    View Item 
    •   ORDA Home
    • University Hospitals of Derby and Burton NHS Foundation Trust
    • Division of Cancer, Diagnostics and Clinical Support
    • Pathology
    • View Item
    •   ORDA Home
    • University Hospitals of Derby and Burton NHS Foundation Trust
    • Division of Cancer, Diagnostics and Clinical Support
    • Pathology
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Analytical Performance Verification of the Beckman Coulter AU5800 Clinical Chemistry Analyser Against Recognized Quality Specifications Reveals Relevance of Method Harmonization

    Thumbnail
    Abstract
    Analytical performance of 24 Beckman-Coulter AU 5800 methods was verified against recognized quality goals and manufacturer's expected imprecision and bias.AU5800 method imprecision, bias, agreement with a comparative method, and linearity were studied using CLSI protocols, commercial control material, patient samples, and linearity test kit solutions. Repeat patient testing and IQC were also used for imprecision. Commutability of control material was tested. Total analytical error (TAE) was estimated for each method and between the tested and the comparative method, the Beckman-Coulter Unicel DxC800.CLSI EP15 total imprecision CV (TCV) < 3.2%. Duplicate patient imprecision CV < 2.8%. IQC imprecision CV < 5.1%, except for low level ALP (CV = 7.4%). Sodium and urate IQC imprecision were higher than manufacturer's specifications. TAE for all methods met accepted quality goals. Correlation between methods was > 0.975, except for Cl (0.971), TP (0.964), and Na (0.948). Average bias versus Unicel DxC800 is high for ALP (17.3%), GGT (37%), LD (20%), TBIL (-23%), and TP (8%) and was confirmed in other laboratories. TAE between methods met allowable total error for 21 analytes. For GGT, between method TAE (23 to 51%) was predictable from expected bias and combined method imprecision. For LD and TP several between method differences were outside boundaries describing expected bias. Linearity was excellent with R2 > 0.997 and deviations met accepted goals.The Beckman-Coulter AU 5800 demonstrates good linearity, low imprecision, and good correlation with previous methods. Observed between method differences suggest ALP, GGT, LD, TBIL, and TP harmonization should be considered.
    URI
    https://orda.derbyhospitals.nhs.uk/handle/123456789/1217
    Collections
    • Pathology [52]
    Date
    2016
    Author
    Reynolds, Tim
    Show full item record

    copyright © 2017  Derby Teaching Hospitals NHS Foundation Trust
    Contact Us | Send Feedback
    Powered by KnowledgeArc
     

     

    Browse

    All of ORDACommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsThis CollectionBy Issue DateAuthorsTitlesSubjects

    Researcher Profiles

    Researchers

    My Account

    Login

    copyright © 2017  Derby Teaching Hospitals NHS Foundation Trust
    Contact Us | Send Feedback
    Powered by KnowledgeArc