What type of samples are used for Method Validation?

Method validation is an essential step in ensuring the reliability and accuracy of laboratory tests. To comprehensively validate a method, it is crucial to include a wide range of sample types that accurately represent the variability in the population that the method will serve.

Using both healthy and diseased samples allows for the assessment of the method's performance across different biological conditions. Healthy control samples provide a baseline for normal physiological levels, while samples from diseased patients reflect the variations and complexities inherent in pathological states. This dual approach helps confirm that the method can accurately differentiate between normal and abnormal values, ensuring it is suitable for clinical or research applications.

Incorporating diverse sample types, including both healthy and diseased individuals, also enhances the robustness of the validation process and provides a more comprehensive understanding of the method’s performance metrics such as sensitivity, specificity, accuracy, and precision. This inclusiveness is vital for establishing confidence in the method across a broad scope of potential real-world applications.