All Times EDT
Keywords: Reference intervals, reference database, medical tests
Clinical laboratory tests often require a reference interval for quantitative tests and the construction of such intervals are common for laboratory tests. Reference Intervals are used to determine unusual or extreme measurements in laboratory medicine. The reference interval is the central interval bounded by the reference limits. In vivo diagnostic devices in ophthalmology and neurology often compare an individual patient’s medical device output/test result against a database of output/test results from subjects deemed to be in good health, for clinical management of the individual patient. The device output/test results from the subjects in good health constitute a reference database (also commonly known as normative database). Establishment of reference limits or reference intervals involves intricate study design and statistical issues, including how to select individuals for a reference population and how to report results from a reference database. This presentation will discuss challenges in study design and statistical analysis methods for medical tests with reference limits or reference intervals.