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基于生物学变异的个性化参考区间应用中的观点与思考:对一名再次感染SARS-CoV-2的女性的四个月观察

Perspective and consideration in the application of personalized reference intervals based on biological variation: a four-month observation of a woman with SARS-CoV-2 reinfection.

作者信息

Hu Gaofeng, Xu Lei, Guo Kai, Li Chenbin

机构信息

National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, PR China.

Department of Clinical Laboratory, Peking University First Hospital, Beijing, PR China.

出版信息

Biochem Med (Zagreb). 2025 Oct 15;35(3):030901. doi: 10.11613/BM.2025.030901. Epub 2025 Aug 15.

Abstract

This study aimed to investigate potential benefit of personalized reference intervals (prRIs) by conducting a four-month observation of a woman with SARS-CoV-2 reinfection. Two types of prRIs were calculated: one derived from the population biological variation (BV) data provided by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) biological variation database (prRIs_), and the other derived from individual variation data (prRIs_). These were subsequently compared. A total of 110 test results encompassing complete blood count (CBC) and leukocyte differential counts from the case were assessed according to the limits of prRIs_, reference change values (RCVs_) and the population-based reference intervals (popRIs). In instances where limited historical health data are available (N ≤ 3), the application of prRIs_ was recommended over prRIs_. The prRIs_ and RCVs_ identified a greater number of potential clinical pathological change compared to popRIs (the ratio of potential abnormal values to total test values: prRIs_ 22/110, RCVs_ 25/110, popRIs 2/110, respectively). The findings suggest that the use of prRIs can be advantageous in clinical settings and is worthy of broader adoption. However, it is essential to choose an appropriate calculation method tailored to the specific clinical context.

摘要

本研究旨在通过对一名新冠病毒再次感染女性进行为期四个月的观察,探讨个性化参考区间(prRIs)的潜在益处。计算了两种类型的prRIs:一种来自欧洲临床化学和检验医学联合会(EFLM)生物变异数据库提供的人群生物变异(BV)数据(prRIs_),另一种来自个体变异数据(prRIs_)。随后对二者进行了比较。根据prRIs_的限值、参考变化值(RCVs_)和基于人群的参考区间(popRIs),对该病例的110份包括全血细胞计数(CBC)和白细胞分类计数的检测结果进行了评估。在可获得的历史健康数据有限(N≤3)的情况下,建议应用prRIs_而非prRIs_。与popRIs相比,prRIs_和RCVs_识别出了更多潜在的临床病理变化(潜在异常值与总检测值的比例分别为:prRIs_ 22/110、RCVs_ 25/110、popRIs 2/110)。研究结果表明,在临床环境中使用prRIs可能具有优势,值得更广泛地采用。然而,必须选择适合特定临床背景的适当计算方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e0e/12334944/20e523c3db14/bm-35-3-030901-f1.jpg

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