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基于常规实验室检测的急诊 COVID-19 预警评分的开发和验证:一项多中心病例对照研究。

Development and validation of an early warning score to identify COVID-19 in the emergency department based on routine laboratory tests: a multicentre case-control study.

机构信息

Department of Laboratory Medicine, Catharina Hospital, Eindhoven, The Netherlands.

Department of Laboratory Medicine, Catharina Hospital, Eindhoven, The Netherlands

出版信息

BMJ Open. 2022 Aug 3;12(8):e059111. doi: 10.1136/bmjopen-2021-059111.

Abstract

OBJECTIVES

Identifying patients with a possible SARS-CoV-2 infection in the emergency department (ED) is challenging. Symptoms differ, incidence rates vary and test capacity may be limited. As PCR-testing all ED patients is neither feasible nor effective in most centres, a rapid, objective, low-cost early warning score to triage ED patients for a possible infection is developed.

DESIGN

Case-control study.

SETTING

Secondary and tertiary hospitals in the Netherlands.

PARTICIPANTS

The study included patients presenting to the ED with venous blood sampling from July 2019 to July 2020 (n=10 417, 279 SARS-CoV-2-positive). The temporal validation cohort covered the period from July 2020 to October 2021 (n=14 080, 1093 SARS-CoV-2-positive). The external validation cohort consisted of patients presenting to the ED of three hospitals in the Netherlands (n=12 061, 652 SARS-CoV-2-positive).

PRIMARY OUTCOME MEASURES

The primary outcome was one or more positive SARS-CoV-2 PCR test results within 1 day prior to or 1 week after ED presentation.

RESULTS

The resulting 'CoLab-score' consists of 10 routine laboratory measurements and age. The score showed good discriminative ability (AUC: 0.930, 95% CI 0.909 to 0.945). The lowest CoLab-score had high sensitivity for COVID-19 (0.984, 95% CI 0.970 to 0.991; specificity: 0.411, 95% CI 0.285 to 0.520). Conversely, the highest score had high specificity (0.978, 95% CI 0.973 to 0.983; sensitivity: 0.608, 95% CI 0.522 to 0.685). The results were confirmed in temporal and external validation.

CONCLUSIONS

The CoLab-score is based on routine laboratory measurements and is available within 1 hour after presentation. Depending on the prevalence, COVID-19 may be safely ruled out in over one-third of ED presentations. Highly suspect cases can be identified regardless of presenting symptoms. The CoLab-score is continuous, in contrast to the binary outcome of lateral flow testing, and can guide PCR testing and triage ED patients.

摘要

目的

在急诊科(ED)识别可能感染 SARS-CoV-2 的患者具有挑战性。症状不同,发病率不同,检测能力可能有限。由于在大多数中心对所有 ED 患者进行 PCR 检测既不可行也不有效,因此开发了一种快速、客观、低成本的早期预警评分,对 ED 患者进行分诊,以确定是否可能感染。

设计

病例对照研究。

地点

荷兰的二级和三级医院。

参与者

该研究纳入了 2019 年 7 月至 2020 年 7 月期间因静脉采血就诊 ED 的患者(n=10417,279 例 SARS-CoV-2 阳性)。时间验证队列涵盖了 2020 年 7 月至 2021 年 10 月期间的患者(n=14080,1093 例 SARS-CoV-2 阳性)。外部验证队列由荷兰三家医院就诊 ED 的患者组成(n=12061,652 例 SARS-CoV-2 阳性)。

主要结局指标

主要结局是在 ED 就诊前 1 天内或就诊后 1 周内出现 1 次或多次 SARS-CoV-2 PCR 检测结果阳性。

结果

由此产生的“CoLab 评分”由 10 项常规实验室测量和年龄组成。该评分具有良好的鉴别能力(AUC:0.930,95%CI 0.909 至 0.945)。最低 CoLab 评分对 COVID-19 具有高灵敏度(0.984,95%CI 0.970 至 0.991;特异性:0.411,95%CI 0.285 至 0.520)。相反,最高评分具有高特异性(0.978,95%CI 0.973 至 0.983;敏感性:0.608,95%CI 0.522 至 0.685)。这些结果在时间和外部验证中得到了证实。

结论

CoLab 评分基于常规实验室测量,可在就诊后 1 小时内获得。根据流行情况,超过三分之一的 ED 就诊可能安全排除 COVID-19。无论症状如何,都可以识别高度可疑的病例。CoLab 评分是连续的,与侧向流动检测的二分结果不同,可指导 PCR 检测并对 ED 患者进行分诊。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1352/9352566/3a637ebbe7e4/bmjopen-2021-059111f01.jpg

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