利用离子淌度谱快速检测呼出气体中的 SARS-CoV-2 感染：一项初步研究。

Rapid point-of-care detection of SARS-CoV-2 infection in exhaled breath using ion mobility spectrometry: a pilot study.

机构信息

Department of Internal Medicine II, University Hospital Rechts Der Isar, School of Medicine, Technical University of Munich, Ismaninger Str. 22, 81675, Munich, Germany.

Institute of Virology, Helmholtz Center Munich, TUM, School of Medicine, Munich, Germany.

出版信息

Eur J Med Res. 2023 Sep 2;28(1):318. doi: 10.1186/s40001-023-01284-3.

DOI:10.1186/s40001-023-01284-3

PMID:37660038

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10474630/

Abstract

BACKGROUND

An effective testing strategy is essential for pandemic control of the novel Coronavirus disease 2019 (COVID-19) caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Breath gas analysis can expand the available toolbox for diagnostic tests by using a rapid, cost-beneficial, high-throughput point-of-care test. We conducted a bi-center clinical pilot study in Germany to evaluate breath gas analysis using multi-capillary column ion mobility spectrometry (MCC-IMS) to detect SARS-CoV-2 infection.

METHODS

Between September 23, 2020, and June 11, 2021, breath gas measurements were performed on 380 patients (SARS-CoV-2 real-time polymerase chain reaction (PCR) positive: 186; PCR negative: 194) presenting to the emergency department (ED) with respiratory symptoms.

RESULTS

Breath gas analysis using MCC-IMS identified 110 peaks; 54 showed statistically significant differences in peak intensity between the SARS-CoV-2 PCR-negative and PCR-positive groups. A decision tree analysis classification resulted in a sensitivity of 83% and specificity of 86%, but limited robustness to dataset changes. Modest values for the sensitivity (74%) and specificity (52%) were obtained using linear discriminant analysis. A systematic search for peaks led to a sensitivity of 77% and specificity of 67%; however, validation by transferability to other data is questionable.

CONCLUSIONS

Despite identifying several peaks by MCC-IMS with significant differences in peak intensity between PCR-negative and PCR-positive samples, finding a classification system that allows reliable differentiation between the two groups proved to be difficult. However, with some modifications to the setup, breath gas analysis using MCC-IMS may be a useful diagnostic toolbox for SARS-CoV-2 infection.

TRIAL REGISTRATION

This study was registered at ClinicalTrials.gov on September 21, 2020 (NCT04556318; Study-ID: HC-N-H-2004).

摘要

背景

有效的检测策略对于控制由严重急性呼吸系统综合征冠状病毒 2 型（SARS-CoV-2）感染引起的新型冠状病毒病 2019（COVID-19）大流行至关重要。呼吸气体分析可以通过使用快速、具有成本效益的高通量即时检测来扩展诊断测试的可用工具包。我们在德国进行了一项双中心临床试点研究，以评估使用多毛细管柱离子迁移谱（MCC-IMS）检测 SARS-CoV-2 感染的呼吸气体分析。

方法

2020 年 9 月 23 日至 2021 年 6 月 11 日，对 380 名因呼吸症状到急诊科就诊的患者（实时聚合酶链反应（PCR）检测 SARS-CoV-2 阳性：186 例；PCR 阴性：194 例）进行了呼吸气体测量。

结果

MCC-IMS 对呼吸气体的分析确定了 110 个峰；54 个峰的峰强度在 SARS-CoV-2 PCR 阴性和 PCR 阳性组之间存在统计学差异。决策树分析分类的敏感性为 83%，特异性为 86%，但对数据集变化的稳健性有限。线性判别分析得到的敏感性（74%）和特异性（52%）值适中。通过系统搜索峰值得到的敏感性为 77%，特异性为 67%；然而，通过转移到其他数据进行验证的可靠性值得怀疑。