可溶性P-选择素作为COVID-19疾病的潜在诊断和预后生物标志物:一项病例对照研究

Soluble P-selectin as a potential diagnostic and prognostic biomarker for COVID-19 disease: A case-control study.

作者信息Emre Karsli, Ramazan Sabirli, Emel Altintas, Omer Canacik, Gizem Tukenmez Sabirli, Buse Kaymaz, Özgür Kurt, Aylin Koseler
PMID34015287
期刊Life Sci
发布时间2021-07-15
DOI10.1016/j.lfs.2021.119634

实验完整度

包含病例对照研究、ELISA检测、ROC分析等明确实验方法,但缺乏功能验证或机制验证,且未提供细胞或动物模型。

主要模型

COVID-19肺炎患者(轻至中度组、重度组) 非症状健康对照志愿者

重点核对

病例和对照组样本量分别为80例患者和60例健康志愿者 按临床指南分为轻至中度肺炎和重度肺炎 使用ELISA检测血清sP-Selectin水平 ROC分析确定诊断最佳截止值为4.125 ng/ml 以CURB-65评分≥3作为预测ICU需求的分组依据

摘要

INTRODUCTION: To our knowledge, the diagnostic value of the sP-Selectin level in the diagnosis of COVID-19 disease has not yet been investigated. In this study, we aimed to assess this by evaluating the relationship between sP-Selectin level and the clinical severity of COVID-19 infections.METHODS: A total of 80 patients (50 with mild to moderate and 30 with severe COVID-19 pneumonia), and 60 non-symptomatic healthy volunteers participated in the study. Following serum isolation, sP-Selectin levels were assessed by Enzyme-Linked Immunosorbent Assay (ELISA) method.RESULTS: The serum sP-Selectin level was 1.7 ng/ml in the control group (1-3.78); 6.24 ng/ml (5.14-7.23) in mild-to-moderate pneumonia group; and 6.72 ng/ml (5.36-8.03) in the severe pneumonia group. Serum sP-Selectin levels in both mild-to-moderate pneumonia and severe pneumonia groups were found to be higher than the control group, with statistical significance (p = 0.0001 and p = 0.0001, respectively). Receiver operating characteristic analysis (ROC) showed greater area under the curve (AUC) for the serum sP-Selectin levels of the COVID-19 patients (AUC = 0.913, 95% CI = 0.857-0.969; p = 0.0001). The serum sP-Selectin level was found to be 97.5% sensitive and 80% specific at 4.125 ng/ml level for diagnosis (p = 0.0001). The serum sP-Selectin level was found to be 76.9% sensitive and 51.9% specific at the level of 6.12 ng/ml (p = 0.005) to predict the need for intensive care treatment.CONCLUSION: This study showed that sP-Selectin can be used as a valuable biomarker in both diagnosing and predicting the need for intensive care treatment of COVID-19 infection.

实验结论

提炼研究问题、关键发现与证据,快速把握文章的核心贡献。

研究问题
血清sP-Selectin水平是否可作为COVID-19的诊断和预后生物标志物,尤其用于预测重症监护需求。
核心机制
COVID-19感染导致内皮细胞损伤和血小板活化,引起sP-Selectin释放增加,反映血栓形成倾向。
主要证据
病例对照研究显示,患者血清sP-Selectin水平显著高于对照,ROC分析显示诊断AUC为0.913,预测ICU需求AUC为0.696。
研究意义
sP-Selectin可作为COVID-19诊断和预测重症监护需求的有价值生物标志物。

研究路径

按研究推进顺序梳理实验设计、验证步骤与关键观察。

1

研究设计与样本采集

验证sP-Selectin水平在COVID-19患者与健康对照中的差异。

纳入80例COVID-19肺炎患者和60例健康对照,采集血液样本分离血清。

2

临床评估与分组

根据临床严重程度对患者进行分组,以评估sP-Selectin与病情的关系。

按卫生部指南将患者分为轻至中度肺炎和重度肺炎,使用CURB-65评分划分ICU需求。

3

血清sP-Selectin水平检测

测定各组血清sP-Selectin浓度并进行比较。

采用ELISA法检测血清sP-Selectin水平,并进行统计学比较。

4

统计分析与诊断价值评估

评估sP-Selectin对COVID-19诊断和预测ICU需求的价值。

使用ROC曲线分析确定最佳截止值,并计算敏感性、特异性。

研究方法

按研究目的归类文中使用的方法,便于定位所需技术。

产品清单

实验环节名称品牌货号
P-选择素 ELISA试剂盒ElabscienceE-EL-H0917

关键环节

汇总复现实验时建议重点确认的条件及原文阅读提示。

环节核对要点
研究对象
患者确诊标准、肺炎严重程度分级标准、健康对照组纳入标准
阅读提示:Methods 2.2, 2.3, 2.4
样本采集与处理
采血量、离心速度和时间
阅读提示:Methods 2.7
sP-Selectin检测
ELISA试剂盒品牌及货号
阅读提示:Methods 2.7
诊断评估
ROC分析的最佳截止值、敏感性和特异性
阅读提示:Results, Fig. 2A
预后评估
预测ICU需求的截止值、敏感性和特异性
阅读提示:Results, Fig. 2B