Legion Diagnostics

Reference Interval

The Reference Interval module verifies that a preestablished reference interval — defined by the manufacturer, a reference laboratory, or a prior large-scale study — is transferable to your laboratory's patient population and test method. A reference interval defines the range of values expected in healthy individuals and serves as the clinical decision boundary for patient results.

Legion Diagnostics currently supports reference interval verification using a small number of reference individuals. Reference interval establishment (de novo validation with ≥ 120 samples) is not yet supported but is planned for a future release.

Verification vs. Validation: Verification confirms that an existing, preestablished reference interval applies to your specific laboratory and population. Validation (establishment) builds a new reference interval from scratch using ≥ 120 reference individuals. This module supports verification only.

When to Use This Module

Reference interval verification is required whenever a laboratory adopts or transfers a preestablished reference interval under new conditions:

  • New method or instrument implementation — When a laboratory introduces a new test method or analyzer for an analyte already in use, the existing reference interval must be verified to confirm it remains applicable to the new method's results.
  • Adopting a manufacturer's reference interval — When a laboratory uses the reference interval provided in the package insert rather than one derived from its own population, verification is required to confirm the manufacturer's interval is suitable for the laboratory's specific patient demographics and specimen handling practices.
  • Adopting an interval from another laboratory — When transferring a reference interval from a comparable laboratory or published literature, the receiving laboratory must verify that its population and preexamination factors are sufficiently similar.
  • Method modification — Changes to antibody, calibrator, or reagent system may shift results enough to invalidate a previously verified interval, necessitating re-verification.
  • Accreditation requirements — CAP and CLIA require laboratories to verify reference intervals as part of method verification records for quantitative tests.