How to define reference intervals to rule in healthy individuals for clinical trials?

Wendy P.J. den Elzen 1 , Joop van Gerven 2 , Paul W. Schenk 1 , Anna Uit Den Boogaard 2 , Ria Kroon 2 , Erica Klaassen 2 , Bart E.P.B. Ballieux 1  and Christa M. Cobbaert 1
  • 1 Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands
  • 2 Centre for Human Drug Research, Leiden, The Netherlands
Wendy P.J. den Elzen, Joop van Gerven, Paul W. Schenk, Anna Uit Den Boogaard, Ria Kroon, Erica Klaassen, Bart E.P.B. Ballieux and Christa M. Cobbaert

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    Horowitz GL, Altaie S, Boyd JC, Ceriotti F, Garg U, Horn P, et al. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline – 3rd ed., volume 28, number 30 (CLSI document C28-A3c).

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    Ozarda Y, Ichihara K, Barth JH, Klee G; Committee on Reference Intervals and Decision Limits (C-RIDL), International Federation for Clinical Chemistry and Laboratory Medicine. Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values (IFCC C-RIDL). Clin Chem Lab Med 2013;51:1027–40.

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    Cobbaert C, Weykamp C, Franck P, de Jonge R, Kuypers A, Steigstra H, et al. Systematic monitoring of standardization and harmonization status with commutable EQA-samples – Five year experience from the Netherlands. Clin Chim Acta 2012;414:234–40.

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    Horn PS, Pesce AJ. Reference intervals: an update. Clin Chim Acta 2003;334:5–23.

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Clinical Chemistry and Laboratory Medicine ( CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor of over three. CCLM is the official journal of nine national clinical societies and associated with EFLM.