Rebecca S. Steinberg MD , Tzu-Chun Chu MPH , Denny Shin MD , Binh Ha PhD , He-Ying Sun PhD , Samadhan J. Jadhao DVM , David N. Ku MD , Blaine R. Roberts PhD , Evan J. Anderson MD , Laila Hussaini MPH , Larry J. Anderson MD , Blake Anderson MD
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The current preferred method of detection is nasopharyngeal swab, which reflects sampling of the upper respiratory tract alone.</div></div><div><h3>Research Question</h3><div>Can we noninvasively assess detection of SARS-CoV-2 RNA and biomarkers in patients’ cough droplets captured with the PneumoniaCheck device?</div></div><div><h3>Study Design and Methods</h3><div>We enrolled adult patients with a recent nasopharyngeal swab that was positive for COVID-19 by polymerase chain reaction (PCR) who were receiving monoclonal antibody infusion therapy. After consent and instruction, patients coughed 5 sets of 10 coughs into the PneumoniaCheck device. Material captured on the device filter was eluted and tested for biomarkers (interferon gamma, tumor necrosis factor alpha [TNF-α], IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, and IL-13) and amylase by an enzyme activity assay, and SARS-CoV-2 RNA by PCR (3 different primer sets).</div></div><div><h3>Results</h3><div>A total of 44 case patients out of 50 cases and 17 control patients with adequate specimen and accompanying clinical data were included in the analysis. Thirty case patient cough specimens (68%) tested PCR positive for SARS-CoV-2 RNA, 10 (23%) tested negative, and 4 (9%) tested indeterminate. IL-13 and TNF-α levels were significantly higher, whereas IL-2 levels were significantly lower in case specimens than in control cough specimens. In the multivariable analysis of biomarkers and reported symptoms, higher IL-10 levels were associated with reduced fatigue (OR, 0.41; 95% CI, 0.15-0.87; <em>P</em> = .039), whereas higher IL-12p70 (OR, 2.74; 95% CI, 1.15-8.51; <em>P</em> = .043), IL-4 (OR, 3.56; 95% CI, 1.56-11.20; <em>P</em> = .008), and TNF-α (OR, 4.36; 95% CI, 1.79-14.60; <em>P</em> = .004) levels were associated with fever.</div></div><div><h3>Interpretation</h3><div>Our results show that the PneumoniaCheck device is a noninvasive method for successfully detecting SARS-CoV-2 and inflammatory cytokines in specimens from the lower respiratory tract in patients with COVID-19 and likely in patients with other lung diseases.</div></div>","PeriodicalId":94286,"journal":{"name":"CHEST pulmonary","volume":"3 3","pages":"Article 100137"},"PeriodicalIF":0.0000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Detection of SARS-CoV-2 RNA and Biomarkers in Device-Captured Droplets From the Lung\",\"authors\":\"Rebecca S. 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引用次数: 0
摘要
自2019年发现sars - cov -2以来，它仍然是一个全球性的健康问题，需要长期的非侵入性临床检测方法。目前首选的检测方法是鼻咽拭子，它反映了上呼吸道的单独采样。研究问题：我们是否可以无创性地评估使用PneumoniaCheck设备捕获的患者咳嗽飞沫中SARS-CoV-2 RNA和生物标志物的检测？研究设计和方法我们招募了近期鼻咽拭子经聚合酶链反应（PCR）检测为COVID-19阳性的成年患者，这些患者正在接受单克隆抗体输注治疗。经同意和指导后，患者咳嗽5组（每组10次）进入PneumoniaCheck装置。在设备过滤器上捕获的材料被洗脱并检测生物标志物（干扰素γ、肿瘤坏死因子α [TNF-α]、IL-1β、IL-2、IL-4、IL-6、IL-8、IL-10、IL-12p70和IL-13）和淀粉酶（酶活性测定），以及SARS-CoV-2 RNA（3种不同的引物组）。结果50例患者中44例纳入分析，17例对照患者标本齐全，临床资料齐全。30例患者咳嗽标本（68%）PCR检测为SARS-CoV-2 RNA阳性，10例（23%）检测为阴性，4例（9%）检测不确定。病例标本中IL-13和TNF-α水平显著高于对照组，IL-2水平显著低于对照组。在生物标志物和报告症状的多变量分析中，较高的IL-10水平与疲劳减轻相关（OR, 0.41; 95% CI, 0.15-0.87; P = 0.039），而较高的IL-12p70 （OR, 2.74; 95% CI, 1.15-8.51; P = 0.043）、IL-4 （OR, 3.56; 95% CI, 1.56-11.20; P = 0.008）和TNF-α (OR, 4.36; 95% CI, 1.79-14.60; P = 0.004)水平与发烧相关。我们的研究结果表明，PneumoniaCheck装置是一种无创方法，可以成功检测COVID-19患者和其他肺部疾病患者下呼吸道标本中的SARS-CoV-2和炎症细胞因子。
Detection of SARS-CoV-2 RNA and Biomarkers in Device-Captured Droplets From the Lung
Background
SARS-CoV-2 remains a global health issue since its discovery in 2019, and long-term noninvasive clinical testing methods are required. The current preferred method of detection is nasopharyngeal swab, which reflects sampling of the upper respiratory tract alone.
Research Question
Can we noninvasively assess detection of SARS-CoV-2 RNA and biomarkers in patients’ cough droplets captured with the PneumoniaCheck device?
Study Design and Methods
We enrolled adult patients with a recent nasopharyngeal swab that was positive for COVID-19 by polymerase chain reaction (PCR) who were receiving monoclonal antibody infusion therapy. After consent and instruction, patients coughed 5 sets of 10 coughs into the PneumoniaCheck device. Material captured on the device filter was eluted and tested for biomarkers (interferon gamma, tumor necrosis factor alpha [TNF-α], IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, and IL-13) and amylase by an enzyme activity assay, and SARS-CoV-2 RNA by PCR (3 different primer sets).
Results
A total of 44 case patients out of 50 cases and 17 control patients with adequate specimen and accompanying clinical data were included in the analysis. Thirty case patient cough specimens (68%) tested PCR positive for SARS-CoV-2 RNA, 10 (23%) tested negative, and 4 (9%) tested indeterminate. IL-13 and TNF-α levels were significantly higher, whereas IL-2 levels were significantly lower in case specimens than in control cough specimens. In the multivariable analysis of biomarkers and reported symptoms, higher IL-10 levels were associated with reduced fatigue (OR, 0.41; 95% CI, 0.15-0.87; P = .039), whereas higher IL-12p70 (OR, 2.74; 95% CI, 1.15-8.51; P = .043), IL-4 (OR, 3.56; 95% CI, 1.56-11.20; P = .008), and TNF-α (OR, 4.36; 95% CI, 1.79-14.60; P = .004) levels were associated with fever.
Interpretation
Our results show that the PneumoniaCheck device is a noninvasive method for successfully detecting SARS-CoV-2 and inflammatory cytokines in specimens from the lower respiratory tract in patients with COVID-19 and likely in patients with other lung diseases.
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