Reference range

A reference range is an interval of test results observed in a defined reference population. It helps interpret an individual measurement but does not by itself determine whether someone is healthy or ill.

Reference interval: An interval covering a specified proportion of results from a defined reference population under stated conditions. This is the formal laboratory term for the interval and makes its population basis explicit.
Clinical decision limit: A threshold linked to clinical outcomes or decisions rather than derived solely from a reference population. Some tests use outcome-based thresholds instead of population reference limits.
Personal reference interval: An individual’s usual measurement interval estimated from repeated results over time. A person’s stable baseline can be more informative than a population interval.
Pre-analytical variability: Variation introduced before analysis by factors such as collection, handling, or preparation of a specimen. Reference samples and patient samples need comparable collection conditions.
Reference interval transferability: The extent to which a reference interval established in one setting applies to another population or laboratory. Different populations and methods can make a published interval unsuitable for local use.
Reference population: A group selected to represent people whose measurements establish a reference interval. The chosen group determines which results the range describes.
Laboratory test: An analysis of a biological specimen used to provide information about health or disease. Reference ranges are commonly reported alongside laboratory measurements.
Biological variation: Natural variation in measurements within one person and between people. Within-person variation helps explain why a population range may miss meaningful changes.
Analytical variability: Variation in measured results caused by the analytical method and its performance. Measurement imprecision can affect estimated limits and comparisons with them.
Reference interval verification: A laboratory process for checking whether an established interval is appropriate for its own method and population. Local verification helps establish whether an adopted range fits the testing setting.

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