背景:在常规蛋白质测量中,血浆和血清之间存在可观察到的定量差异,通常不反映在标准参考间隔中。在这项研究中,我们描述了一种估计组合参考区间(RI)的间接方法(即,血清和血浆),对于通常订购的蛋白质被测量物:总蛋白质,白蛋白,和球蛋白。
方法:我们使用2018年7月至2024年2月的数据,对血清和血浆中的蛋白质测量应用了间接参考区间估计。根据COVID-19大流行期间血浆分离器管短缺的一段时间,数据分为三个时期。使用引导重采样来计算每个月的RI和相应的95%置信区间。
结果:我们的结果表明,总蛋白的RI限值发生了显著变化,白蛋白,和球蛋白在历代之间,反映样本矩阵变化的影响。使用来自20个健康个体的血浆和血清样品以及使用新的和历史的RI对我们的门诊人群的标记率进行回顾性分析,确定了所有成分的组合RI,并进行了验证。
结论:该研究表明,总蛋白的RIs存在显着差异,白蛋白,和球蛋白当容器类型变化。此外,结果证明了大数据分析在推导RI方面的有效性,并强调了根据患者群体和可接受的样本类型进行持续RI评估和调整的必要性.
BACKGROUND: Observable quantitative variations exist between plasma and serum in routine protein measurements, often not reflected in standard reference intervals. In this study, we describe an indirect approach for estimating a combined reference interval (RI) (i.e., serum and plasma), for commonly ordered protein measurands: total protein, albumin, and globulin.
METHODS: We applied an indirect reference interval estimation for protein measurements in serum and plasma using data from July 2018 to February 2024. The data were divided into three Epochs based on a period of plasma separator tube shortage during the COVID-19 pandemic. Bootstrap resampling was used to calculate RIs and corresponding 95% confidence intervals for each month.
RESULTS: Our results demonstrate notable changes in RI limits for total protein, albumin, and globulin between Epochs, reflecting the influence of changing sample matrix. A combined RI was identified for all components and verified using plasma and serum samples from 20 healthy individuals and retrospective analysis of flagging rates on our outpatient population using new and historical RIs.
CONCLUSIONS: The study demonstrates notable differences in the RIs for total protein, albumin, and globulin when container type changes. In addition, the results demonstrate the effectiveness of big data analytics in deriving RIs and highlights the necessity of continuous RI assessment and adjustment based on the patient population and acceptable specimen types.