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Pediatric reference intervals: Challenges and recent initiatives

机译：儿科参考区间：挑战和最近的举措

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摘要

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.
机译：临床实验室通过提供关于特定生物标志物的客观数据在医疗保健递送方面发挥着关键作用，这些数据直接有助于诊断和监测各种临床疾病。实验室分析的可靠性和准确的参考间隔是正确解释临床实验室测试结果的积分，因此，适用于适当的临床决策。理想情况下，应基于健康人口建立参考间隔，并为包括年龄，性别和种族的关键协变者分层。然而，建立参考间隔可能具有挑战性，因为它需要来自健康个体的大量样本。这种挑战进一步增强了儿科，其中由于儿童生长和发展导致动态变化显着影响疾病生物标志物的循环水平。结果，甚至需要更大的参考填充以可靠地计算参考间隔。在这篇综述中，我们概述了特定于建立儿科参考区间的挑战，并突出旨在关闭现有知识中现有差距的最新举措。我们还概述了推荐的参考间隔和详细介绍了几种替代方法的方法。最后，与许多潜在的替代样品类型一起讨论了对小儿疾病的新兴和新型生物标志物的参考间隔。

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