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Published on: February 2, 2017
Pediatric reference intervals: challenges and recent initiatives
Julie L V Shaw1, Tina Binesh Marvasti, David Colantonio
1Division of Clinical Biochemistry, Department of Paediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Insights
Establishing reliable pediatric reference intervals for clinical laboratory tests is crucial for accurate diagnosis and treatment. This review addresses the challenges in pediatric biomarker analysis and proposes solutions for developing essential reference ranges.
Area of Science:
- Clinical Chemistry
- Pediatric Medicine
- Biomarker Discovery
Background:
- Clinical laboratories provide essential biomarker data for disease diagnosis and monitoring.
- Accurate reference intervals are vital for interpreting laboratory results and guiding clinical decisions.
- Establishing reference intervals requires large, healthy populations, posing challenges, especially in pediatrics due to growth and developmental changes.
Purpose of the Study:
- To review the challenges in establishing pediatric reference intervals for biomarkers.
- To highlight initiatives addressing knowledge gaps in pediatric reference intervals.
- To discuss recommended and alternative approaches for developing reference intervals.
Main Methods:
- Literature review of challenges and initiatives in pediatric reference interval establishment.
- Analysis of recommended and alternative methods for reference interval development.
- Discussion of emerging biomarkers and alternative sample types for pediatric testing.
Main Results:
- Pediatric reference intervals are complex due to dynamic physiological changes.
- Several initiatives are underway to improve pediatric reference interval data.
- Various approaches, including alternative sample types, are being explored for novel biomarkers.
Conclusions:
- Addressing the challenges in pediatric reference interval development is critical for accurate healthcare.
- Continued research and collaboration are needed to establish robust pediatric reference ranges.
- The development of reference intervals for novel pediatric biomarkers and alternative sample types is an evolving area.
Abstract:
The clinical laboratory plays a critical role in healthcare delivery by providing objective data on specific biomarkers that directly aid in the diagnosis and monitoring of a wide range of clinical disorders. Reliable and accurate reference intervals for laboratory analyses are integral for correct interpretation of clinical laboratory test results and, therefore, for appropriate clinical decision-making. Ideally, reference intervals should be established based on a healthy population and stratified for key covariates including age, gender and ethnicity. However, establishing reference intervals can be challenging as it requires the collection of large numbers of samples from healthy individuals. This challenge is further augmented in pediatrics, where dynamic changes due to child growth and development markedly affect circulating levels of disease biomarkers. As a result, even larger reference populations are required to reliably calculate reference intervals. In this review, we outline the challenges specific to establishing pediatric reference intervals and highlight recent initiatives aimed at closing existing gaps in current knowledge. We also outline recommended approaches to the development of reference intervals and detail several alternative approaches. Finally, reference intervals for emerging and novel biomarkers of pediatric disease are discussed along with a number of potential alternative sample types.
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