Fig. 3. Composition of nine samples according to the values in the linearity validation panel of study design (A) and (B). In study design A, if the low-sample (S9) is not available, the blank sample can replace S9 if all four of the following conditions are satisfied: 1) The absolute value of ADL is less than LLoQ; 2) Numeric values (including negative values) should be provided for the measurement of the blank samples; 3) LLLI is equal to or greater than ADL; 4) S8 is both close to and larger than LLoQ. (Reprinted with permission from Clinical and Laboratory Standards Institute from: CLSI. Evaluation of Linearity of Quantitative Measurement Procedures. 2nd ed. CLSI guideline EP06. Clinical and Laboratory Standards Institute, 2020 [12]).
Abbreviations: LLLI, lower limit of linearity interval; ULLI, upper limit of linearity interval; LLoQ, lower limit of quantitation; ULoQ, upper limit of quantitation; ADL, allowable deviation from linearity.

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