Verification and Validation of Reference Intervals in Clinical Laboratories
Why is validation and Verification of Clinical Lab Reference Interval Required? Introduction Understanding Reference Intervals: Reference intervals are the normal ranges for laboratory test results in a healthy population. They are essential for interpreting test results and determining if a patient's values are within or outside the expected range. Verification and validation of reference intervals are crucial processes in clinical laboratories, each serving distinct purposes in ensuring the accuracy and reliability of laboratory test results. Verification of Reference Intervals: Verification refers to the process of confirming that a pre-established reference interval is applicable to a specific laboratory's population and testing methods. This is typically done when a laboratory adopts reference intervals from external sources, such as manufacturers or other laboratories. The verification process can be accomplished using a smaller sample size, often as few as 20 ...