在美国人口中验证CALIPER儿科参考间隔,使用回顾性门诊数据和RefineR
Jillian Kodger1, Thomas J S Durant2, Nalan Yurtsever1
1Department of Laboratory Medicine, Yale School of Medicine, New Haven, CT, USA.
Clinica chimica acta; international journal of clinical chemistry
|January 21, 2026
概括
RefineR方法与加拿大实验室儿童参考间隔倡议 (CALIPER) 相比,对儿科实验室结果的CLSI指南更符合. 这种方法对于美国多样化的儿科门诊患者群体来说更准确.
科学领域:
- 临床实验室医学 临床实验室医学
- 儿科参考间隔 发育发展
- 生物统计在医疗保健中的应用
背景情况:
- 准确的儿科参考间隔 (RI) 对于解释实验室结果至关重要,但面临着诸如生理变异和有限的样本大小等挑战.
- 本研究评估了加拿大儿科参考间隔实验室倡议 (CALIPER) RIs在多样化的美国儿科门诊环境中的适用性.
- 两种方法,RefineR反向建模和临床和实验室标准研究所 (CLSI) EP28-A3c,用于评估.
研究的目的:
- 评估现有的加拿大实验室儿科参考间隔倡议 (CALIPER) 对美国儿科门诊患者群体的适用性.
- 为了比较RefineR反向建模方法与CLSI EP28-A3c推方法用于推导儿科参考间隔的性能.
- 评估RefineR的准确性和实用性,以制定特定人群的儿科参考间隔.
主要方法:
- 在2023年1月至2024年12月期间,收集了来自51,863名儿科患者 (19岁以下) 的门诊实验室数据.
- 通过使用RefineR和CLSI指导方针与引导重新抽样,为九种常见化学分析物推导了参考间隔 (RIs).
- 通过使用基于95%置信区间和允许总误差 (TAE) 的标记系统,与CALIPER RIs进行比较.
主要成果:
- 在88个特定年龄和性别的分析组中,RefineR衍生的RI与CALIPERRI在86个组中保持一致.
- 来自CLSI的RI在88个组中有77个组显示一致,这表明一致性较低.
- 针对特定分析物 (例如ALT,AST,ALP,BUN) 发现了差异,这些差异受样本类型,BMI和水分状态等因素的影响.
结论:
- 在美国儿科门诊患者队列中,RefineR与CLSI指南相比,与CALIPER RIs的结合性更好.
- RefineR是一种强大而实用的方法,用于推导特定人群的儿科参考间隔,有效地处理混合数据和倾斜分布.
- 该RefineR方法有助于验证外部RI的实施,如CALIPER,在不同的儿科群体.
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