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Problems associated with clinical chemistry quality control materials

C G Fraser, M J Peake

    CRC Critical Reviews in Clinical Laboratory Sciences
    |January 1, 1980
    PubMed
    Summary
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    Quality control materials are essential for clinical chemistry labs, but their use presents challenges. This review highlights issues with material composition, stability, and analyte value assignment for accurate lab performance monitoring.

    Area of Science:

    • Clinical Chemistry
    • Laboratory Medicine
    • Analytical Chemistry

    Background:

    • Quality control (QC) materials are vital for monitoring clinical chemistry laboratory performance and validating analytical methods.
    • A diverse array of liquid and lyophilized QC materials are commercially available or prepared in-house.
    • The effective use of QC materials is frequently hindered by various practical and technical issues.

    Purpose of the Study:

    • To review and assess the challenges and considerations associated with the use of quality control materials in clinical chemistry.
    • To critically evaluate the advantages and disadvantages of different types of QC materials.
    • To emphasize the importance of accurate analyte value assignment in QC materials for assessing laboratory method performance.

    Main Methods:

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    • Comprehensive literature review of publications related to quality control in clinical chemistry.
    • Analysis of common problems encountered with QC materials, including their composition, characteristics, and stability.
    • Discussion of the physical and chemical properties of QC materials in comparison to patient samples.
    • Evaluation of strategies for generating QC materials with elevated analyte levels.
    • Assessment of handling, storage, and reconstitution challenges.

    Main Results:

    • Identified issues include the use of non-human or animal-derived materials, differences between QC materials and patient samples, and difficulties in achieving desired analyte levels.
    • Storage, handling, and stability (both before and after reconstitution) pose significant challenges.
    • Hepatitis transmission risks associated with certain materials are a concern.
    • Assigning accurate analyte values to QC materials is critical for evaluating both imprecision and inaccuracy of laboratory methods.

    Conclusions:

    • Addressing the identified problems in quality control material usage is fundamental to ensuring reliable clinical chemistry laboratory performance.
    • Careful selection and appropriate use of both liquid and lyophilized QC materials are necessary.
    • Accurate value assignment and understanding material characteristics are paramount for effective quality control and method evaluation.