A mask-based diagnostic platform for point-of-care screening of Covid-19

In this study, we introduce a different concept based on exhaled breath condensate (EBC), readily collected by a mask-based sampling device, and detection with an electrochemical biosensor with a modular architecture that enables fast and specific detection and quantification of COVID-19.
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Abstract

Diagnostics of SARS-CoV-2 infection using real-time reverse-transcription polymerase chain reaction (RT-PCR) on nasopharyngeal swabs is now well-established, with saliva-based testing being lately more widely imple- mented for being more adapted for self-testing approaches. In this study, we introduce a different concept based on exhaled breath condensate (EBC), readily collected by a mask-based sampling device, and detection with an electrochemical biosensor with a modular architecture that enables fast and specific detection and quantification of COVID-19. The face mask forms an exhaled breath vapor containment volume to hold the exhaled breath vapor in proximity to the EBC collector to enable a condensate-forming surface, cooled by a thermal mass, to coalesce the exhaled breath into a 200–500 μL fluid sample in 2 min. EBC RT-PCR for SARS-CoV-2 genes (E, ORF1ab) on samples collected from 7 SARS-CoV-2 positive and 7 SARS-CoV-2 negative patients were performed. The presence of SARS-CoV-2 could be detected in 5 out of 7 SARS-CoV-2 positive patients. Furthermore, the EBC samples were screened on an electrochemical aptamer biosensor, which detects SARS-CoV-2 viral particles down to 10 pfu mL− 1 in cultured SARS-CoV-2 suspensions. Using a “turn off” assay via ferrocenemethanol redox mediator, results about the infectivity state of the patient are obtained in 10 min.

This study was originally published online at Elsevier B.V. on 8 July 2021. Click here to view a PDF of the full article.

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DiagMetrics Secures Key U.S. Patents Covering Breath-Based Diagnostics and Strengthens Intellectual Property Leadership

DiagMetrics, Inc. has been granted three U.S. patents — 12,369,816; 12,092,639; and 12,031,982 — covering its Mask-Based Diagnostic™ (MBD™) platform for collecting and analyzing exhaled breath condensate (EBC). These patents secure broad protection for the company’s innovations in EBC collection, diagnostic integration with rapid assays and biosensors, and thermal mass condensation technologies. The new IP strengthens DiagMetrics’ leadership in non-invasive, breath-based diagnostics, supporting its mission to deliver affordable, scalable solutions for global health challenges including infectious disease, oncology, cardiology, and chronic disease monitoring

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