Which of the following is NOT typically included in method validation criteria?

• A. Accuracy
• B. Specificity
• C. Linearity
• D. Sample throughput

Answer: (D)

In analytical method validation, you focus on how well the method measures the target analyte under defined conditions, using criteria that describe the quality of the measurement itself. Accuracy is about closeness to the true value, specificity is about ensuring the method measures only the analyte in the presence of interferences, and linearity assesses that the response is proportional to concentration across a range. Sample throughput, on the other hand, is about how many samples can be processed in a given time—an operational or efficiency metric, not a property of the measurement accuracy or reliability. Therefore, it is not typically included as a validation criterion.