Detection of SARS-CoV-2 infection by exhaled breath spectral analysis: Introducing a ready-to-use point-of-care mass screening method.
Detection of SARS-CoV-2 infection by exhaled breath spectral analysis: Introducing a ready-to-use point-of-care mass screening method.
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DOI：
10.1016/j.eclinm.2022.101308
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发表时间：
2022-03
影响因子：
15.1
通讯作者：
Greenhut AK
中科院分区：
文献类型：
--
作者：
Shlomo IB;Frankenthal H;Laor A;Greenhut AK
目前的SARS-CoV-2大流行迫切需要对大量无症状的个人进行快速的感染筛查。迄今为止，鼻咽拭子聚合酶链式反应(PCR)被认为是“金标准”。然而，这不利于大规模护理点(POC)测试，因为在采样过程中人们感到不适，并且结果周转时间较长。针对疾病特定有机化合物的呼气测试可能提供一种实用、快速、非侵入性的POC解决方案。这项研究将健康呼吸有限公司(BOH)的呼吸分析系统与聚合酶链式反应筛查无症状个体感染SARS-CoV-2的能力进行了比较。BOH系统是移动的，将傅立叶变换红外光谱(FTIR)与人工智能(AI)相结合，在2分钟和15分钟内产生结果，S。与之前的SARS-CoV-2呼气分析研究不同，本研究侧重于通过疾病特异性光谱图谱而不是通过识别疾病特异性分子来诊断SARS-CoV-2。2021年2月至4月期间，在以色列两家主要医院选择了疑似接触SARS-CoV-2病毒的无症状急诊室患者。所有患者均通过鼻咽拭子聚合酶链式反应和呼气分析进行检测。共抽取297例患者(平均年龄57·08 SD18·86，男156例，女139例，未知数2例)。其中，96人(男性44人，女性50人，未知2人)，201人(男性112人，女性89人)。100个样本被用于SARS-CoV-2的人工智能识别、波数模式识别和诊断算法的创建。算法验证在100个概念验证样本(34个聚合酶链式反应阳性，66个聚合酶链式反应阴性)中进行，方法是将聚合酶链式反应与由盲目医学专家确定的基于AI算法的呼气测试结果进行比较。另外100个样本(12个真阳性，85个真阴性，3个混杂的假阳性[不包括在297个总样本中])由两个盲法医学专家进行评估，以进一步验证算法和专家间的关联。BOH系统确定了SARS-CoV-2感染的三个明显波号。在第一阶段，单一专家正确地识别了前100个样品，产生了1：1的FTIR/AI：PCR相关性。两个专家的第二阶段对97个非混杂因素也产生了1：1的FTIR/AI：PCR相关性，而对3个混杂因素的相关性为零。所有结果的专家间相关性均为1：1。总体而言，与PCR相比，FTIR/AI算法对SARS-CoV-2的检测具有100%的敏感性和特异性。SARS-CoV-2呼气分析方法通过FTIR和基于AI的算法显示，在筛查无症状个体方面具有很高的PCR相关性。这是第一个实用、快速的POC呼气分析解决方案，在无症状个体中具有如此高的PCR相关性。如果样本量较大，则需要进一步验证。以色列雷霍沃特的健康呼吸有限公司提供了研究资金。
The current SARS-CoV-2 pandemic created an urgent need for rapid, infection screening applied to large numbers of asymptomatic individuals. To date, nasal/throat swab polymerase chain reaction (PCR) is considered the “gold standard”. However, this is inconducive to mass, point-of-care (POC) testing due to person discomfort during sampling and a prolonged result turnaround. Breath testing for disease specific organic compounds potentially offers a practical, rapid, non-invasive, POC solution. The study compares the Breath of Health, Ltd. (BOH) breath analysis system to PCR's ability to screen asymptomatic individuals for SARS-CoV-2 infection. The BOH system is mobile and combines Fourier-transform infrared (FTIR) spectroscopy with artificial intelligence (AI) to generate results within 2 min and 15 s. In contrast to prior SARS-CoV-2 breath analysis research, this study focuses on diagnosing SARS-CoV-2 via disease specific spectrometric profiles rather than through identifying the disease specific molecules. Asymptomatic emergency room patients with suspected SARS-CoV-2 exposure in two leading Israeli hospitals were selected between February through April 2021. All were tested via nasal/throat-swab PCR and BOH breath analysis. In total, 297 patients were sampled (mean age 57·08 SD 18·86, 156 males, 139 females, 2 unknowns). Of these, 96 were PCR-positive (44 males, 50 females, 2 unknowns), 201 were PCR-negative (112 males, 89 females). One hundred samples were used for AI identification of SARS-CoV-2 distinguishing spectroscopic wave-number patterns and diagnostic algorithm creation. Algorithm validation was tested in 100 proof-of-concept samples (34 PCR-positive, 66 PCR-negative) by comparing PCR with AI algorithm-based breath-test results determined by a blinded medical expert. One hundred additional samples (12 true PCR-positive, 85 true PCR-negative, 3 confounder false PCR-positive [not included in the 297 total samples]) were evaluated by two blinded medical experts for further algorithm validation and inter-expert correlation. The BOH system identified three distinguishing wave numbers for SARS-CoV-2 infection. In the first phase, the single expert identified the first 100 samples correctly, yielding a 1:1 FTIR/AI:PCR correlation. The two-expert second-phase also yielded 1:1 FTIR/AI:PCR correlation for 97 non-confounders and null correlation for the 3 confounders. Inter-expert correlation was 1:1 for all results. In total, the FTIR/AI algorithm demonstrated 100% sensitivity and specificity for SARS-CoV-2 detection when compared with PCR. The SARS-CoV-2 method of breath analysis via FTIR with AI-based algorithm demonstrated high PCR correlation in screening for asymptomatic individuals. This is the first practical, rapid, POC breath analysis solution with such high PCR correlation in asymptomatic individuals. Further validation is required with a larger sample size. Breath of Health Ltd, Rehovot, Israel provided study funding.
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DOI：
10.1016/j.jmoldx.2021.09.005
发表时间：
2021-12
期刊：
The Journal of molecular diagnostics : JMD
影响因子：
--
作者：
Duan C;Buerer L;Wang J;Kaplan S;Sabalewski G;Jay GD;Monaghan SF;Arena AE;Fairbrother WG
通讯作者：
Fairbrother WG
Lumiradx微流体免疫荧光的性能在无症状的成年人和儿童中的现状SARS-COV-2抗原测试。
影响因子：
3.5
作者：
Drain P;Sulaiman R;Hoppers M;Lindner NM;Lawson V;Ellis JE
通讯作者：
Ellis JE
DOI：
10.1007/s42399-020-00341-w
发表时间：
2020-01-01
期刊：
SN comprehensive clinical medicine
影响因子：
--
作者：
Bwire, George M
通讯作者：
Bwire, George M
影响因子：
3.3
作者：
Hjoberg, J;Shore, S;Silverman, ES
通讯作者：
Silverman, ES
影响因子：
3.7
作者：
Arevalo-Rodriguez I;Buitrago-Garcia D;Simancas-Racines D;Zambrano-Achig P;Del Campo R;Ciapponi A;Sued O;Martinez-García L;Rutjes AW;Low N;Bossuyt PM;Perez-Molina JA;Zamora J
通讯作者：
Zamora J