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Summary
This summary is machine-generated.

Harmonizing laboratory reference intervals (RIs) ensures consistent patient results across different testing platforms. This approach, supported by various data sources, improves diagnostic accuracy and facilitates inter-laboratory comparisons for better healthcare outcomes.

Keywords:
adultharmonisationpaediatricreference intervalsstandardisationtransference

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Medical Diagnostics

Background:

  • Harmonisation of reference intervals (RIs) aims for consistent RIs across diverse analytical platforms and assays.
  • Optimal harmonisation requires robust calibration, traceability, and evidence of minimal bias between methods.
  • Various data sources inform RI selection, including local studies, literature, surveys, and manufacturer data.

Purpose of the Study:

  • To define and advocate for the harmonisation of laboratory reference intervals.
  • To explore strategies for establishing common reference intervals across different laboratories and regions.
  • To encourage the adoption and local validation of harmonised RIs.

Main Methods:

  • Reviewing existing literature and guidelines on reference interval harmonisation.
  • Assessing pre-analytical factors, partitioning, significant figures, and flagging rates for analytes.
  • Examining international examples of common RI implementation (e.g., Nordic countries, UK, Canada).

Main Results:

  • Several countries and regions have successfully implemented common RIs through direct studies or consensus.
  • Canada is exploring common reference values using CALIPER and CHMS databases.
  • Platform-specific common reference values may be a practical approach for non-standardised analytes.

Conclusions:

  • Harmonisation of reference intervals is achievable and beneficial for consistent diagnostic interpretation.
  • Adopting common RIs, where appropriate, and performing local validation is recommended for laboratories.
  • Platform-specific harmonisation offers a pragmatic solution for many analytes lacking primary standardisation.