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

Yesim Ozarda, Kiyoshi Ichihara, Julian H. Barth, George Klee

Research output: Contribution to journalArticle

51 Scopus citations

Abstract

The reference intervals (RIs) given in laboratory reports have an important role in aiding clinicians in interpreting test results in reference to values of healthy populations. In this report, we present a proposed protocol and standard operating procedures (SOPs) for common use in conducting multicenter RI studies on a national or international scale. The protocols and consensus on their contents were refined through discussions in recent C-RIDL meetings. The protocol describes in detail (1) the scheme and organization of the study, (2) the target population, inclusion/ exclusion criteria, ethnicity, and sample size, (3) health status questionnaire, (4) target analytes, (5) blood collection, (6) sample processing and storage, (7) assays, (8) cross-check testing, (9) ethics, (10) data analyses, and (11) reporting of results. In addition, the protocol proposes the common measurement of a panel of sera when no standard materials exist for harmonization of test results. It also describes the requirements of the central laboratory, including the method of cross-check testing between the central laboratory of each country and local laboratories. This protocol and the SOPs remain largely exploratory and may require a reevaluation from the practical point of view after their implementation in the ongoing worldwide study. The paper is mainly intended to be a basis for discussion in the scientific community.

Original languageEnglish (US)
Pages (from-to)1027-1040
Number of pages14
JournalClinical Chemistry and Laboratory Medicine
Volume51
Issue number5
DOIs
StatePublished - May 2013

Keywords

  • Cross-check study
  • Harmonization
  • Multicenter study
  • Panel of sera
  • Reference interval
  • Standardization

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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