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Prerequisites for use of common reference intervals.

Ferruccio Ceriotti1

  • 1Diagnostica e Ricerca San Raffaele SpA, Milano, Italy. ceriotti.ferruccio@hsr.it

The Clinical Biochemist. Reviews
|October 3, 2007
PubMed
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Establishing common reference intervals in clinical laboratories is crucial. Multicenter studies, using standardized methods and traceable results, overcome challenges in creating reliable reference values for diverse populations.

Area of Science:

  • Clinical Laboratory Science
  • Biostatistics
  • Analytical Chemistry

Background:

  • The theory of reference values, established over 30 years ago, has incomplete application in clinical laboratories.
  • Key challenges include lack of analytical method standardization (leading to method-dependent values) and difficulties in recruiting sufficient reference subjects.
  • Recent advances in method standardization and multicenter collaborative studies offer solutions.

Purpose of the Study:

  • To outline the prerequisites and procedures for establishing common reference intervals through multicenter studies.
  • To address the challenges of method-dependent values and subject recruitment in reference interval determination.
  • To guide clinical laboratories in adopting and validating common reference intervals.

Main Methods:

Related Experiment Videos

  • Utilizing a reference measurement system for the analyte.
  • Employing field methods with results traceable to the reference system.
  • Conducting carefully planned multicenter reference interval studies with controlled pre-analytical conditions.

Main Results:

  • Multicenter studies produce traceable results from a large number of subjects under controlled conditions.
  • These studies enhance understanding of population variability and inform decisions on reference interval partitioning or limitations.
  • Established common reference intervals can be adopted by laboratories meeting specific criteria.

Conclusions:

  • Multicenter studies are effective for establishing common reference intervals, overcoming previous limitations.
  • Adoption of common reference intervals requires similar patient populations, traceable methods, and defined analytical quality.
  • Validation using local reference individuals is advisable for successful implementation.