In method validation, calibrators should cover which range?

In method validation, calibrators should cover which range?

• A. The expected concentration range of patient samples.
• B. Only zero concentration.
• C. A random range not related to patient samples.
• D. Only the highest concentration.

Answer: (A)

In method validation for quantitative assays, calibrators define the relationship between instrument response and concentration, so they must cover the concentrations you expect in patient samples. This ensures you can accurately interpolate results across the whole range you’ll encounter, not just at one point. Covering the expected range lets you validate linearity, accuracy, and precision throughout the measurement window and confirms that the lower and upper ends (like LLOQ and ULOQ) are reliable. If calibrators only included zero, or only the highest value, or a random unrelated range, you’d end up with results that are not verifiable across the concentrations you actually measure, risking extrapolation beyond validated limits. So the calibrators should bracket the expected sample concentrations to ensure measurements are accurate and trustworthy within that range.

In method validation for quantitative assays, calibrators define the relationship between instrument response and concentration, so they must cover the concentrations you expect in patient samples. This ensures you can accurately interpolate results across the whole range you’ll encounter, not just at one point.

Covering the expected range lets you validate linearity, accuracy, and precision throughout the measurement window and confirms that the lower and upper ends (like LLOQ and ULOQ) are reliable. If calibrators only included zero, or only the highest value, or a random unrelated range, you’d end up with results that are not verifiable across the concentrations you actually measure, risking extrapolation beyond validated limits.

So the calibrators should bracket the expected sample concentrations to ensure measurements are accurate and trustworthy within that range.