Department of Pulmonary Disease and Tuberculosis, The Third People's Hospital of Shenzhen, No. 29, Bulan Road, Longgang District, Shenzhen 518112, Guangdong, People's Republic of China.
Breax Laboratory, PCAB Research Center of Breath and Metabolism, Beijing, People's Republic of China.
J Breath Res. 2022 Sep 12;16(4). doi: 10.1088/1752-7163/ac8ea1.
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a tremendous threat to global health. polymerase chain reaction (PCR) and antigen testing have played a prominent role in the detection of SARS-CoV-2-infected individuals and disease control. An efficient, reliable detection tool is still urgently needed to halt the global COVID-19 pandemic. Recently, the food and drug administration (FDA) emergency approved volatile organic component (VOC) as an alternative test for COVID-19 detection. In this case-control study, we prospectively and consecutively recruited 95 confirmed COVID-19 patients and 106 healthy controls in the designated hospital for treatment of COVID-19 patients in Shenzhen, China. Exhaled breath samples were collected and stored in customized bags and then detected by high-pressure photon ionization time-of-flight mass spectrometry for VOCs. Machine learning algorithms were employed for COVID-19 detection model construction. Participants were randomly assigned in a 5:2:3 ratio to the training, validation, and blinded test sets. The sensitivity (SEN), specificity (SPE), and other general metrics were employed for the VOCs based COVID-19 detection model performance evaluation. The VOCs based COVID-19 detection model achieved good performance, with a SEN of 92.2% (95% CI: 83.8%, 95.6%), a SPE of 86.1% (95% CI: 74.8%, 97.4%) on blinded test set. Five potential VOC ions related to COVID-19 infection were discovered, which are significantly different between COVID-19 infected patients and controls. This study evaluated a simple, fast, non-invasive VOCs-based COVID-19 detection method and demonstrated that it has good sensitivity and specificity in distinguishing COVID-19 infected patients from controls. It has great potential for fast and accurate COVID-19 detection.
严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)对全球健康造成了巨大威胁。聚合酶链反应(PCR)和抗原检测在检测 SARS-CoV-2 感染个体和疾病控制方面发挥了重要作用。目前仍迫切需要一种高效、可靠的检测工具来阻止全球 COVID-19 大流行。最近,食品和药物管理局(FDA)紧急批准挥发性有机成分(VOC)作为 COVID-19 检测的替代方法。在这项病例对照研究中,我们前瞻性地连续招募了 95 名确诊的 COVID-19 患者和 106 名健康对照者,这些患者在深圳市指定的 COVID-19 治疗医院接受治疗。采集呼出的呼吸样本并储存在定制的袋子中,然后通过高压光子电离时间飞行质谱法检测 VOC。采用机器学习算法构建 COVID-19 检测模型。参与者被随机分配到训练集、验证集和盲测集,比例为 5:2:3。采用敏感性(SEN)、特异性(SPE)和其他一般指标评估基于 VOC 的 COVID-19 检测模型性能。基于 VOC 的 COVID-19 检测模型表现良好,在盲测集上的 SEN 为 92.2%(95%CI:83.8%,95.6%),SPE 为 86.1%(95%CI:74.8%,97.4%)。发现了 5 种与 COVID-19 感染相关的潜在 VOC 离子,它们在 COVID-19 感染患者和对照组之间存在显著差异。本研究评估了一种简单、快速、非侵入性的基于 VOC 的 COVID-19 检测方法,证明其在区分 COVID-19 感染患者和对照组方面具有良好的敏感性和特异性。它在快速、准确检测 COVID-19 方面具有巨大潜力。