Padawer Dan, Qadan Abed, Karameh Mutaz, Darawshy Fares, Laor Arie, Banker Sinora, Fridlender Zvi G
Institute of Pulmonary Medicine, Hadassah Medical Center, Jerusalem, Israel.
Department of Internal Medicine D, Hadassah Medical Center, Jerusalem, Israel.
Infect Dis (Lond). 2024 May;56(5):376-383. doi: 10.1080/23744235.2024.2313020. Epub 2024 Feb 29.
Nucleic acid amplification tests (NAAT) are considered the gold standard for COVID-19 diagnosis. These tests require professional manpower and equipment, long processing and swab sampling which is unpleasant to the patients. Several volatile organic compounds (VOCs) have been identified in the breath of COVID-19 patients. Detection of these VOCs using a breath test could help rapidly identify COVID-19 patients.
Assess the accuracy of 'Breath of Health' (BOH) COVID-19 Fourier-transform infra-red (FTIR) Spectroscopy-based breath test.
Breath samples from patients with or without symptoms suggestive for COVID-19 who had NAAT results were collected using Tedlar bags and were blindly analysed using BOH FTIR spectroscopy. BOH Measures several VOCs simultaneously and differentiating positive and negative results. BOH results were compared to NAAT results as gold standard.
Breath samples from 531 patients were analysed. The sensitivity of BOH breath test was found to be 79.5% and specificity was 87.2%. Positive predictive value (PPV) was 74.7% and negative predictive value (NPV) 90.0%. Calculated accuracy rate was 84.8% and area under the curve 0.834. Subgroup analysis revealed that the NPV of patients without respiratory symptoms was superior over the NPV of symptomatic patients (94.7% vs 80.7%, -value < 0.0001) and PPV of patients with respiratory symptoms outranks the PPV of individuals without symptoms (85.3% vs 69.2%, -value 0.0196).
We found BOH COVID-19 breath test to be a patient-friendly, rapid, non-invasive diagnostic test with high accuracy rate and NPV that could efficiently rule out COVID-19 especially among individuals with low pre-test probability.
核酸扩增检测（NAAT）被认为是新冠病毒疾病（COVID-19）诊断的金标准。这些检测需要专业人员和设备，检测过程长，且咽拭子采样会让患者感到不适。在COVID-19患者的呼吸中已鉴定出几种挥发性有机化合物（VOC）。使用呼气测试检测这些VOC有助于快速识别COVID-19患者。
评估基于“健康呼吸”（BOH）COVID-19傅里叶变换红外（FTIR）光谱的呼气测试的准确性。
使用泰德拉袋收集有或无COVID-19症状提示且有NAAT检测结果的患者的呼气样本，并使用BOH FTIR光谱进行盲法分析。BOH可同时测量多种VOC并区分阳性和阴性结果。将BOH结果与作为金标准的NAAT结果进行比较。
分析了531名患者的呼气样本。发现BOH呼气测试的敏感性为79.5%，特异性为87.2%。阳性预测值（PPV）为74.7%，阴性预测值（NPV）为90.0%。计算得出的准确率为84.8%，曲线下面积为0.834。亚组分析显示，无呼吸道症状患者的NPV优于有症状患者的NPV（94.7%对80.7%，P值<0.0001），有呼吸道症状患者的PPV高于无症状个体的PPV（85.3%对69.2%，P值0.0196）。
我们发现BOH COVID-19呼气测试是一种对患者友好、快速、非侵入性的诊断测试，具有高准确率和NPV，可有效排除COVID-19，尤其是在检测前概率较低的个体中。
