Table. 1.
Comparison of EP06-A [11] and EP06-A2 [12] guidelines for evaluating linearity
| Variable | EP06-A (2003) | EP06-ED2 (2020) |
|---|---|---|
| Validation and verification | Not clearly separated | Clearly separated |
| Requirements for validation | 7–11 samples and 2–4 replicates | 9 samples (recommended) and at least 4 replicates |
| Requirements for verification | 5–7 samples and duplicates | At least 5 samples and at least 2 replicates |
| Concentration ranges of samples | Not specified | Validation: relatively specified according to LI and AMI Verification: differentiated according to the %CV |
| How to prepare linearity panels | Mixing the low and high-level samples by considering the ratio | Equal volume mixing, proportional mixing, or serial dilution |
| Method for analyzing the linearity |
Best-fit polynomial regression |
Weighted first-order (linear) regression |
| Acceptance criteria | |%bias|≤%target (or, absolute bias ≤absolute target in the low level) |
Validation: |%deviation|≤%ADL (%deviation: between measured mean value and predicted value after applying the weight) Verification: if any of the upper and lower limits of 90% CIs of the %deviation overlaps with ADL |
*The images were modified from the Laboratory Medicine, 6th ed. (Korean Society for Laboratory Medicine, 2021 [15]).
Abbreviations: LI, linearity interval; ADL, allowable deviation from linearity; AMI, analytical measuring interval; CV, coefficient of variation; CI, confidence interval.
Lab Med Online 2024;14:163~175 https://doi.org/10.47429/lmo.2024.14.3.163
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