Based on CLIA regulation before implementation every method in a clinical laboratory should be validated. Validation process assures that performance characteristics of a laboratory test are good enough to test a patient specimen. Accuracy, precision, analytical sensitivity (limit of detection) analytical specificity, analytical measurement range, linearity correlation with a reference laboratory, carry over, recovery, and specimen’s stability are the studies that are performed to validate a laboratory developed test. The validation services cover both moderate (FDA approved) and high complexity (laboratory developed) methods and includes providing a validation plan and acceptance criteria, validation experiment procedure, data analysis of validation results, preparation of final validation reports, assistance for correlation study, and suggestion for sources of reference materials used for the validation studies.
