Ichihara, KiyoshiBarth, Julian H.Klee, George2022-03-212022-03-212013-05Özarda, Y. vd. (2013). "Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values". Clinical Chemistry and Laboratory Medicine, 51(5), 1027-1040.1434-66211437-4331https://doi.org/10.1515/cclm-2013-0249https://www.degruyter.com/document/doi/10.1515/cclm-2013-0249/htmlhttp://hdl.handle.net/11452/25237The 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.eninfo:eu-repo/semantics/openAccessMedical laboratory technologyCross-check studyHarmonizationMulticenter studyPanel of seraReference intervalStandardizationApproved recommendation 1987Collected reference valuesReference intervalsStatistical treatmentSerumTubesIndividualsSpecimensProposalBlood specimen collectionCalibrationClinical chemistry testsHealthy volunteersHumansLaboratoriesQuality controlReference valuesArticle0003184959000242-s2.0-848822768011027104051523633469Medical laboratory technologyClinical Chemistry; Thyrotropin; Chemical SpeciesArticleBlood samplingBlood storageEthnicityHealth statusHumanMulticenter study (topic)Normal humanPriority journalQuality controlQuestionnaireReference valueSample size