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不同血样类型对降钙素原定量检测的影响。

The Effects of Different Blood Sample Types on Quantitative Detection of Procalcitonin.

出版信息

Clin Lab. 2022 Feb 1;68(2). doi: 10.7754/Clin.Lab.2021.210530.

Abstract

BACKGROUND

Procalcitonin (PCT) has been recommended and widely used for the prognosis, diagnosis, and monitoring of sepsis. Currently, a majority of PCT detection products are limited to using serum samples, which requires the tedious pre-treatment process, as well as a large sample volume for analysis. Hence, there is an increasing need to replace serum with plasma or whole blood samples. In this work, we evaluated the effects of different blood sample types on PCT quantitative detection by measuring PCT levels in clinically homogenous whole blood, plasma, and serum samples, in hope of extending the application of PCT detection in more sample types.

METHODS

Ninety patients from Tong Ren Hospital of Shanghai Jiao Tong University, School of Medicine with different PCT levels volunteered for this study. Clinically homogenous samples, including EDTA- K2 anticoagulant whole blood, centrifuged serum and procoagulant plasma, were collected and analyzed using i-Reader S automatic immunoanalyzer and its supporting reagent kits. Passing and Bablok regression analysis, Bland-Altman plotting, and Kappa test were used for consistency analysis and the determination of consistency intensity, respectively.

RESULTS

Correlation analysis showed that PCT concentrations measured from EDTA-K2 anticoagulated plasma samples had a good linear regression relationship with PCT from serum samples, with a slope of 0.8741, r = 0.958, p < 0.05. A similar correlation was observed between whole blood and serum, with a slope of 0.9234, r = 0.965, p < 0.05. A good correlation was found from the quantitative results of different sample types obtained from the same patient. In detail, PCT levels in EDTA-K2 anticoagulant whole blood and plasma are well correlated with that in the serum (r = 0.831, p < 0.05; r = 0.814, p < 0.05). There was no significant difference among different sample types (p > 0.05). Variation in PCT quantification induced by different sample types has no statistical influence on positive/negative decision (p > 0.05). Bland-Altman analysis for assessing PCT concentration agreement showed there was no outlier ratio between whole blood and plasma within the range of the detection system, as well as no outlier between serum and plasma. Kappa coefficient of PCT concentration between serum and homologous EDTA-K2 anticoagulated plasma was 0.8942 (p < 0.001), and for serum and homologous whole blood it was 0.6954 (p < 0.001).

CONCLUSIONS

We concluded that quantitative PCT detection can be conducted in different sample types with good correlation and consistency, which means that it is feasible to replace serum samples with whole blood and/or plasma samples for PCT detection in clinical use. These findings reduce the sample volume and turnover time of PCT detection in clinical labs, greatly improving the process of PCT detection and promoting the application of PCT as an important inflammatory biomarker for disease diagnosis.

摘要

背景

降钙素原(PCT)已被推荐并广泛用于脓毒症的预后、诊断和监测。目前,大多数 PCT 检测产品仅限于使用血清样本,这需要繁琐的预处理过程,以及大量的样本量进行分析。因此,越来越需要用血浆或全血样本替代血清。在这项工作中,我们通过测量临床同质的全血、血浆和血清样本中的 PCT 水平,评估了不同血液样本类型对 PCT 定量检测的影响,希望能将 PCT 检测扩展到更多的样本类型。

方法

来自上海交通大学医学院同仁医院的 90 名 PCT 水平不同的患者自愿参加了这项研究。采集并分析了含有 EDTA-K2 抗凝剂的全血、离心血清和促凝血浆等临床同质样本,使用 i-Reader S 自动免疫分析仪及其配套试剂进行分析。采用 Passing-Bablok 回归分析、Bland-Altman 绘图和 Kappa 检验分别进行一致性分析和一致性强度的确定。

结果

相关性分析表明,EDTA-K2 抗凝血浆样本中 PCT 浓度与血清样本中 PCT 浓度具有良好的线性回归关系,斜率为 0.8741,r=0.958,p<0.05。全血与血清之间也观察到类似的相关性,斜率为 0.9234,r=0.965,p<0.05。从同一患者的不同样本类型获得的定量结果之间存在良好的相关性。具体来说,EDTA-K2 抗凝全血和血浆中的 PCT 水平与血清中的 PCT 水平密切相关(r=0.831,p<0.05;r=0.814,p<0.05)。不同样本类型之间无显著差异(p>0.05)。不同样本类型引起的 PCT 定量变化对阳性/阴性判断无统计学影响(p>0.05)。Bland-Altman 分析评估 PCT 浓度的一致性显示,在检测系统的范围内,全血和血浆之间没有离群比值,血清和血浆之间也没有离群值。血清与同源 EDTA-K2 抗凝血浆中 PCT 浓度的 Kappa 系数为 0.8942(p<0.001),血清与同源全血的 Kappa 系数为 0.6954(p<0.001)。

结论

我们得出结论,不同样本类型的定量 PCT 检测具有良好的相关性和一致性,这意味着在临床应用中用全血和/或血浆样本替代血清样本进行 PCT 检测是可行的。这些发现减少了临床实验室中 PCT 检测的样本量和周转时间,极大地改善了 PCT 检测过程,并促进了 PCT 作为疾病诊断的重要炎症生物标志物的应用。

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