Analytical quality goals derived from the total deviation from patients' homeostatic set points, with a margin for analytical errors

Abstract

The deviation of test results from patients' homeostatic set points in steady‐state conditions may complicate interpretation of the results and the comparison of results with clinical decision limits. In this study the total deviation from the homeostatic set point is defined as the maximum absolute deviation for 95% of measurements, and we present analytical quality requirements that prevent analytical error from increasing this deviation to more than about 12% above the value caused by biology alone. These quality requirements are: 1) The stable systematic error should be ≈0, and 2) a systematic error that will be detected by the control program with 90% probability, should not be larger than half the value of the combined analytical and intra‐individual standard deviation. As a result, when the most common control rules are used, the analytical standard deviation may be up to 0.15 times the intra‐individual standard deviation. Analytical improvements beyond these requirements have little impact on the interpretability of measurement results.

• Clinical chemistry tests
• clinical laboratory techniques
• quality control