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Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
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Published on: November 30, 2022

Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values.

Yesim Ozarda1, Kiyoshi Ichihara, Julian H Barth

  • 1Department of Biochemistry and Clinical Biochemistry, Uludag University Medical School of Medicine, Bursa, Turkey.

Clinical Chemistry and Laboratory Medicine
|May 2, 2013
PubMed
Summary
This summary is machine-generated.

This report proposes a standardized protocol for multicenter reference interval (RI) studies. It aims to harmonize laboratory testing and improve clinical interpretation of results by defining common procedures for global studies.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Biostatistics

Background:

  • Reference intervals (RIs) are crucial for interpreting laboratory test results.
  • Current multicenter RI studies lack standardized protocols, hindering comparability.

Purpose of the Study:

  • To present a proposed protocol and standard operating procedures (SOPs) for conducting multicenter reference interval studies.
  • To facilitate harmonization of laboratory testing across national and international scales.

Main Methods:

  • Detailed protocol covering study design, population, questionnaires, analytes, sample handling, assays, and data analysis.
  • Proposal for common measurement of serum panels for harmonization.
  • Requirements for central laboratories and cross-check testing procedures.

Main Results:

  • A comprehensive protocol and SOPs for multicenter RI studies are presented.
  • The protocol addresses key aspects from participant selection to result reporting.
  • A method for harmonizing results using common serum panels is proposed.

Conclusions:

  • The proposed protocol and SOPs provide a framework for standardized multicenter RI studies.
  • Implementation in ongoing studies will allow for practical reevaluation.
  • This work serves as a basis for scientific community discussion on RI standardization.