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Between and within calibration variation: implications for internal quality control rules.

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Summary
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High calibration variability (CVbetween:CVwithin ratio) increases false rejection rates for common quality control (QC) rules. Laboratories should avoid specific QC rules like 2:2S, 4:1S, and 10X when this ratio is elevated.

Keywords:
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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Quality Control

Background:

  • Calibration variability can exceed within-run variation, impacting measurement accuracy.
  • The ratio of between- to within-calibration variance (CVbetween:CVwithin) is a critical factor in assay performance.

Purpose of the Study:

  • To evaluate the impact of varying CVbetween:CVwithin ratios on the false rejection rate and bias detection probability of common quality control (QC) rules.
  • To assess the performance of Westgard QC rules (2:2S, 4:1S, 10X) under different calibration variability conditions.

Main Methods:

  • Analysis of variance (ANOVA) was used to determine CVbetween:CVwithin ratios from historical QC data for six routine clinical chemistry assays.
  • Simulation modeling examined the false rejection rate and bias detection probability of three Westgard QC rules across a range of CVbetween:CVwithin ratios, bias magnitudes, and QC events per calibration.

Main Results:

  • The CVbetween:CVwithin ratios for the studied assays ranged from 1.1 to 34.5.
  • False rejection rates exceeded 10% when CVbetween:CVwithin ratios were greater than 3.
  • Increasing ratios led to higher false rejection rates for QC rules using more consecutive results, though bias detection remained maximal.

Conclusions:

  • Elevated CVbetween:CVwithin ratios significantly increase false rejection rates for the 2:2S, 4:1S, and 10X QC rules.
  • Laboratories should exercise caution and consider alternative QC strategies for measurement procedures with high calibration variability, especially when numerous QC events are used per calibration.