Method validation ensures the test method produces reliable and accurate results.

Parameters like accuracy, precision, specificity, and sensitivity are evaluated.

Repeatability measures consistency of results under the same conditions.

Specificity measures the ability to detect the analyte without interference.

Calibration ensures instruments provide accurate measurements.

Sensitivity is the lowest amount of analyte that can be accurately detected.

Precision measures the closeness of repeated measurements to each other.

Documentation provides evidence of validation and supports audits.

The method must be reviewed, adjusted or replaced before use.