Opinion Paper: Deriving Harmonised Reference Intervals - Global Activities.
Harmonisation of reference intervals (RIs) refers to use of the same or common RI across different platforms and /or assays for a specified analyte. It occurs optimally for those analytes where there is sound calibration and traceability in place and evidence from a between-method comparison shows that bias would not prevent the use of a common RI. The selection of the RI will depend on various sources of information including local formal RI studies, published studies from the literature, laboratory surveys, manufacturer's product information, relevant guidelines, and mining of databases. Pre-analytical and partitioning issues, significant figures and flagging rates, are assessed for each analyte. Several countries and regions including the Nordic countries, United Kingdom, Japan, Turkey, and Australasia are using common RIs that have been determined either by direct studies or by a consensus process. In Canada, the Canadian Society of Clinical Chemists Taskforce is assessing the feasibility of establishing common reference values using the CALIPER (Canadian Laboratory Initiative on Pediatric Reference Intervals) and CHMS (The Canadian Health Measures Survey) databases as the basis. Development of platform-specific common reference values for each of the major analytical systems may be a more practical approach especially for the majority of analytes that are not standardised against a primary reference method and are not traceable to a primary or secondary reference material. We encourage laboratories to consider adopting reference intervals consistent with those used by other laboratories in your region where it is possible and appropriate for your local population. Local validation of the adopted reference interval is also recommended as per CLSI guidelines.
Pathology Queensland, Royal Brisbane and Women's Hospital , Brisbane, QLD, Australia.
Jillian R
JR
Tate
NSW Health Pathology , Chatswood, NSW, Australia.
Gus
G
Koerbin
Clinical Biochemistry, The Hospital for Sick Children, University of Toronto , ON, Canada.
Khosrow
K
Adeli
adult; harmonisation; paediatric; reference intervals; standardisation; transference
Clin Biochem Rev. 2004 May;25(2):99-104
18458709
Clin Biochem Rev. 2014 Feb;35(1):3-14
24659833
Clin Chem. 2012 May;58(5):854-68
22371482
Clin Chem Lab Med. 2015 Sep 1;53(10):e239-43
25883205
Clin Chem. 2015 Aug;61(8):1012-5
26089382
Clin Chem Lab Med. 2014 Dec;52(12):1823-33
25153598
Clin Biochem. 2014 Feb;47(3):166-72
24316101
Clin Biochem Rev. 2014 Nov;35(4):213-35
25678727
Clin Chim Acta. 2014 May 15;432:99-107
24183842
Clin Biochem. 2015 Jan;48(1-2):93-6
25445233
Clin Biochem Rev. 2012 Nov;33(4):133-9
23267245
Ann Clin Biochem. 2011 May;48(Pt 3):195-7
21555538
Clin Chim Acta. 2014 May 15;432:119-21
24144864
Clin Biochem. 2013 Sep;46(13-14):1197-219
23578738
Clin Chem Lab Med. 2013 Aug;51(8):1663-72
23612542
Clin Biochem. 2006 Jun;39(6):588-94
16762334
Clin Chem. 2008 Feb;54(2):356-65
18089659
Clin Chem Lab Med. 1999 Nov-Dec;37(11-12):1131-3
10726823
Scand J Clin Lab Invest. 2004;64(4):271-84
15223694
Clin Biochem. 2006 Jun;39(6):600-5
16430880
Clin Biochem. 2014 Jun;47(9):812-5
24726493
Clin Chem. 2014 Dec;60(12):1532-42
25261558
Clin Chem Lab Med. 2011 Dec 20;50(5):813-7
22628318
Clin Biochem. 2006 Jun;39(6):569-87
16624272
Clin Chem. 2015 Aug;61(8):1009-11
26078442
Clin Chim Acta. 2014 May 15;432:22-6
24183840
Pathology. 2015 Feb;47(2):138-44
25551303
Clin Biochem Rev. 2008 Aug;29 Suppl 1:S93-7
18852866
Clin Chem. 2015 Aug;61(8):1063-74
26044507
Clin Biochem Rev. 2014 Nov;35(4):243-50
25678729
Clin Chem. 2015 Aug;61(8):1075-86
26044509
Clin Biochem Rev. 2014 Nov;35(4):203-11
25678726
Clin Biochem. 2013 May;46(7-8):642-51
23337690
Clin Chem. 2013 Aug;59(8):1215-27
23637248
Clin Biochem. 2011 May;44(7):480-482
22036336
Clin Chem. 2014 Mar;60(3):518-29
24366727
Clin Chem. 2015 Aug;61(8):1049-62
26044506
Clin Biochem. 2015 Sep;48(13-14):828-36
25977068
Kidney Int. 2013 Sep;84(3):622-3
23989362
Clin Biochem. 2016 Jan;49(1-2):139-49
26297116
Scand J Clin Lab Invest. 2013 Feb;73(1):1-9
23013046
Clin Chem. 2013 Sep;59(9):1393-405
23637247
Clin Biochem. 2015 Nov;48(16-17):1151-9
25979809
Clin Biochem. 2006 Jun;39(6):595-9
16595129
Clin Biochem. 2015 Sep;48(13-14):870-80
26070714