Establishment of Biological Reference Interval

According to the International Organization for Standardization ISO 15189/5.5.5, the biological reference interval should be reviewed periodically. If the laboratory has reason to believe that a particular reference interval is no longer applicable to the reference population, it should investigate and, if necessary, take corrective measures. When the laboratory changes the test procedure or the pre-test procedure, the biological reference interval should also be re-evaluated if applicable. Therefore, in actual clinical applications, in addition to determining the reference range for new test methods and test items, it is necessary to periodically review the test methods and items that have been applied to the clinic or verify them with appropriate procedures. If not applicable, it must be re-established. Therefore, the establishment of a reliable biological reference interval for upcoming and ongoing testing projects is one of the essential tasks that need to be accomplished in pre-clinical and clinical applications.