A European Quality Control Programme as a cooperative tool between users and a diagnostic company

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Immunochemistry

Background:

• Precision is a critical quality metric in clinical laboratories, particularly for specialized assays like immunochemistry.
• Immunochemical methods present unique challenges for accuracy assessment due to the absence of universal reference methods.
• Key sources of variation in immunochemical assays include methodology, lot-to-lot differences, and assay performance (technician skill, instrument function).

Purpose of the Study:

• To compare the precision of a European Quality Control Programme for automated immunoassay analyzers with an Italian Quality Control Programme using diverse immunometric techniques.
• To evaluate the impact of quality control programs on the analytical performance of clinical laboratory assays.

Main Methods:

• Comparison of precision (percentage coefficient of variation, %CV) between two distinct quality control programs.
• Assessment of the proportion of results falling within half of the biological variation for serum components.
• Analysis of data from a European Quality Control Programme and an Italian Quality Control Programme.

Main Results:

• Quality control programs effectively highlight areas for improvement in assay performance.
• Feedback loops between users and manufacturers contribute to enhanced analytical precision.
• A significant improvement in analysis performance was observed, with most values falling within acceptable biological variation limits.

Conclusions:

• National and international quality control programs are essential for assessing the intrinsic quality of clinical laboratory measurements.
• Collaborative quality control efforts lead to improved precision and reliability in specialized laboratory testing.
• Continuous quality improvement in immunochemistry is achievable through structured control programs and user-manufacturer collaboration.