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Closing the gaps in paediatric reference intervals: the CALIPER initiative
Kareena Schnabl1, Man Khun Chan, Yanping Gong
1Clinical Biochemistry Division, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Insights
Accurate paediatric reference intervals are crucial for diagnosing childhood diseases. A new Canadian initiative, CALIPER, aims to create an updated database for paediatric laboratory tests, addressing critical data gaps.
Area of Science:
- Clinical Biochemistry
- Paediatric Laboratory Medicine
- Biomarker Discovery
Background:
- Accurate interpretation of paediatric disease biomarkers requires reliable reference intervals.
- Existing paediatric reference intervals are outdated, often based on old technology, leading to potential misdiagnosis.
- Gaps in paediatric reference intervals hinder effective screening, diagnosis, and monitoring of childhood diseases.
Purpose of the Study:
- To highlight the critical need for updated paediatric reference intervals.
- To identify challenges in establishing paediatric reference intervals.
- To introduce the CALIPER initiative for creating a comprehensive paediatric reference interval database.
Main Methods:
- Review of current approaches to establishing laboratory reference intervals.
- Identification of data gaps in paediatric populations.
- Overview of the CALIPER initiative's methodology and goals.
Main Results:
- Significant deficiencies exist in current paediatric laboratory reference intervals.
- Challenges include paediatric specimen collection, method harmonization, and population differences.
- The CALIPER initiative is developing a harmonized database for paediatric reference intervals.
Conclusions:
- Urgent need for a comprehensive and accurate paediatric reference interval database.
- Addressing challenges in data collection and standardization is key.
- The CALIPER initiative offers a promising solution for improving paediatric diagnostic accuracy.
Abstract:
Screening, diagnosis and monitoring of paediatric diseases relies on the measurement of a spectrum of disease biomarkers in clinical laboratories to guide important clinical decisions. Physicians rely on the availability of suitable and reliable reference intervals to accurately interpret laboratory test results with data collected during medical history and physical examination. However, critical gaps currently exist in accurate and up-to-date reference intervals (normal values) for accurate interpretation of laboratory tests performed in children and adolescents. These gaps in the available paediatric laboratory reference intervals have the clear potential of contributing to erroneous diagnosis or misdiagnosis of many diseases of childhood and adolescence. Most of the available reference intervals for laboratory tests were determined over two decades ago on older instruments and technologies, and are no longer relevant considering the current testing technology used by clinical laboratories. It is thus critical and of utmost urgency that a more acceptable and comprehensive database be established. There are however many challenges when attempting to establish paediatric reference intervals. Paediatric specimen collection is a major concern for health care providers as it is frequently difficult to obtain sufficient volumes of blood or urine from paediatric patients. Common reference intervals have not been widely implemented due to lack of harmonisation of methods and differences in patient populations. Consequently, clinical laboratory accreditation organisations and licensing agencies require that each laboratory verify or establish reference intervals for each method. To provide such reference intervals requires selection criteria for suitable reference individuals, defined conditions for specimen collection and analysis, method selection to determine reference limits and validation of the reference interval. The current review will provide a brief introduction to the current approach to establishment of reference intervals, will highlight the current gaps in data available in paediatric populations, and review a recent Canadian initiative, CALIPER (Canadian Laboratory Initiative on Paediatric Reference Intervals), to establish a comprehensive database for both traditional and emerging biomarkers of paediatric disease.
