Abstract

Worldwide there appear to be two main approaches to addressing the gap in paediatric biochemistry reference intervals: (1) large scale, government-funded reference interval studies based on recruiting healthy children, and (2) ‘harmonisation' to achieve common reference intervals (CRI). The first are national paediatric-focused reference interval studies, including CALIPER study (Canadian Laboratory Initiative on Pediatric Reference Intervals,), KiGGS (The German Health Interview and Examination Survey for Children and Adolescents), NORICHILD (Scandinavian Initiative for the Establishment of Pediatric Reference Intervals) and CHILDx (Children's Health Improvement through Laboratory Diagnostics) by ARUP Laboratories and the University of Utah, NIH. The second approach is a national or regional group undertaking the task of defining common reference intervals using a multicentre study design. The RIs are determined via collaboration of laboratories from different regions that use analytical methods traceable to a reference method. UK Harmony, ARQAG (Auckland Regional Quality Assurance Group) and SIQAG (South Island Quality Assurance Group) have taken this approach for adult and paediatric biochemistry RIs. This is also the approach recommended by the Australian Association of Clinical Biochemists (AACB) Paediatric Special Interest Group. Unfortunately there is no perfect solution; both approaches have obstacles that hinder the implementation by laboratories. Recent data from CALIPER suggest transference of RIs to all major instrument platforms may be possible based on their population studies

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