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Clinical trial and detection of SARS-CoV-2 by a commercial breath analysis test based on Terahertz technology.

ABSTRACT: Public health threats such as the current COVID-19 pandemics have required prompt action by the local, national, and international authorities. Rapid and noninvasive diagnostic methods may provide on-site detection and immediate social isolation, used as tools to rapidly control virus spreading. Accordingly, the aim of the present study was to evaluate a commercial breath analysis test (TERA.Bio®) and deterministic algorithm for detecting the SARS-CoV-2 spectral signature of Volatile Organic Compounds present in exhaled air samples of suspicious persons from southern Brazil. A casuistic total of 70 infected and 500 non-infected patients were sampled, tested, and results later compared to RT-qPCR as gold standard. Overall, the test showed 92.6% sensitivity and 96.0% specificity. No statistical correlation was observed between SARS-CoV-2 positivity and infection by other respiratory diseases. Further studies should focus on infection monitoring among asymptomatic persons. In conclusion, the breath analysis test herein may be used as a fast, on-site, and easy-to-apply screening method for diagnosing COVID-19.

SUBMITTER: De Almeida MB

PROVIDER: S-EPMC9488804 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Clinical trial and detection of SARS-CoV-2 by a commercial breath analysis test based on Terahertz technology.

De Almeida Meila Bastos MB Aharonov-Nadborny Regina R Gabbai Eran E Palka Ana Paula AP Schiavo Leticia L Esmanhoto Elis E Riediger Irina I Rocha Jaime J Margulis Ariel A Loureiro Marcelo M Pettan-Brewer Christina C Kmetiuk Louise Bach LB De Barros-Filho Ivan Roque IR Biondo Alexander Welker AW

PloS one 20220920 9

Public health threats such as the current COVID-19 pandemics have required prompt action by the local, national, and international authorities. Rapid and noninvasive diagnostic methods may provide on-site detection and immediate social isolation, used as tools to rapidly control virus spreading. Accordingly, the aim of the present study was to evaluate a commercial breath analysis test (TERA.Bio®) and deterministic algorithm for detecting the SARS-CoV-2 spectral signature of Volatile Organic Com ...[more]

PMID: 36126048

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Project description:Effective and efficient management of human betacoronavirus severe acute respiratory syndrome (SARS)-CoV-2 virus infection i.e., COVID-19 pandemic, required sensitive and selective sensors with short sample-to-result durations for performing desired diagnostics. In this direction, one appropriate alternative approach to detect SARS-CoV-2 virus protein at low level i.e., femtomolar (fM) is exploring plasmonic metasensor technology for COVID-19 diagnostics, which offers exquisite opportunities in advanced healthcare programs, and modern clinical diagnostics. The intrinsic merits of plasmonic metasensors stem from their capability to squeeze electromagnetic fields, simultaneously in frequency, time, and space. However, the detection of low-molecular weight biomolecules at low densities is a typical drawback of conventional metasensors that has recently been addressed using toroidal metasurface technology. This research is focused on the fabrication of a miniaturized plasmonic immunosensor based on toroidal electrodynamics concept that can sustain robustly confined plasmonic modes with ultranarrow lineshapes in the terahertz (THz) frequencies. By exciting toroidal dipole mode using our quasi-infinite metasurface and a judiciously optimized protocol based on functionalized gold nanoparticles (AuNPs) conjugated with the specific monoclonal antibody specific to spike protein (S1) of SARS-CoV-2 virus onto the metasurface, the resonance shifts for diverse concentrations of the spike protein are monitored. Possessing molecular weight around ~76 kDa allowed to detect the presence of SARS-CoV-2 virus protein with significantly low as limit of detection (LoD) was achieved as ~4.2 fM. We envisage that outcomes of this research will pave the way toward the use of toroidal metasensors as practical technologies for rapid and precise screening of SARS-CoV-2 virus carriers, symptomatic or asymptomatic, and spike proteins in hospitals, clinics, laboratories, and site of infection.

Project description:BackgroundFrom a public health perspective, the identification of individuals with mild respiratory symptoms due to SARS-CoV-2 infection is important to contain the spread of the disease. The objective of this study was to identify volatile organic compounds (VOCs) in exhaled breath common to infection with different variants of the SARS-CoV-2 virus to inform the development of a point-of-care breath test to detect infected individuals with mild symptoms.MethodsA prospective, real-world, observational study was conducted on mildly symptomatic out-patients presenting to community test-sites for RT-qPCR SARS-CoV-2 testing when the Alpha, Beta, and Delta variants were driving the COVID-19 pandemic. VOCs in exhaled breath were compared between PCR-positive and negative individuals using TD-GC-ToF-MS. Candidate VOCs were tested in an independent set of samples collected during the Omicron phase of the pandemic.FindingsFifty breath samples from symptomatic RT-qPCR positive and 58 breath samples from test-negative, but symptomatic participants were compared. Of the 50 RT-qPCR-positive participants, 22 had breath sampling repeated 8-12 weeks later. PCA-X model yielded 12 distinct VOCs that discriminated SARS-CoV-2 active infection compared to recovery/convalescence period, with an area under the receiver operator characteristic curve (AUROC), of 0.862 (0.747-0.977), sensitivity, and specificity of 82% and 86%, respectively. PCA-X model from 50 RT-qPCR positive and 58 negative symptomatic participants, yielded 11 VOCs, with AUROC of 0.72 (0.604-0.803) and sensitivity of 72%, specificity 65.5%. The 11 VOCs were validated in a separate group of SARS-CoV-2 Omicron positive patients' vs healthy controls demonstrating an AUROC of 0.96 (95% CI 0.827-0.993) with sensitivity of 80% specificity of 90%.InterpretationExhaled breath analysis is a promising non-invasive, point-of-care method to detect mild COVID-19 infection.FundingFunding for this study was a competitive grant awarded from the Vancouver Coastal Research Institute as well as funding from the BC Cancer Foundation.

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Clinical trial and detection of SARS-CoV-2 by a commercial breath analysis test based on Terahertz technology.

Publications

Clinical trial and detection of SARS-CoV-2 by a commercial breath analysis test based on Terahertz technology.

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