Reference intervals: the way forward

Ann Clin Biochem 2009;46:8-17
doi:10.1258/acb.2008.008170
© 2009 Association for Clinical Biochemistry

 

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What’s this?

Review Article


Ferruccio Ceriotti1,
Rolf Hinzmann2 and
Mauro Panteghini3


1 Diagnostica e Ricerca San Raffaele S.p.A, Milan, Italy;
2 Sysmex Europe GmbH, Norderstedt, Germany;
3 Department of Clinical Sciences ‘Luigi Sacco’, University of Milan, Milan, Italy


Corresponding author: Ferruccio Ceriotti. Email: ceriotti.ferruccio{at}hsr.it

New facts have recently enhanced interest in the topic of reference intervals. In particular, the International Organization for Standardization standard 15189, requesting that ‘biological reference intervals shall be periodically reviewed’, and the directive of the European Union on in vitro diagnostic medicaldevices asking manufacturers to provide detailed informationon reference intervals, have renewed interest in the subject.This review presents an update on the topic, discussing thetheoretical aspects and the most critical issues. The basicapproach to the definition of reference intervals proposed inthe original International Federation of Clinical Chemistrydocuments still remain valid. The use of data mining to obtainreference data from existing databases has severe limitations.New statistical approaches to discard outliers and to computereference limits have been recommended. On the other hand, perspectivesopened by the improvement in standardization through the implementationof the concept of traceability suggest new models to define‘common’ reference intervals that can be transferredand adopted by different clinical laboratories in order to decreasethe proliferation of different reference intervals not alwaysjustified by differences in population characteristics or inanalytical methodology.


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