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13 March 2024 Saliva-based extraction-free molecular assay for rapid diagnostics of SARS-CoV-2
Michael Margulis, Hanan Rohana, Oran Erster, Michal Mandelboim, Asaf Biber, Eli Schwartz, Avi Peretz, Amos Danielli
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Proceedings Volume PC12861, Frontiers in Biological Detection: From Nanosensors to Systems XVI; PC1286108 (2024) https://doi.org/10.1117/12.3008270
Event: SPIE BiOS, 2024, San Francisco, California, United States
Abstract
The COVID-19 pandemic has emphasized the inability of diagnostic laboratories' testing capacity to keep up with the surging demand. The primary reasons were the lack of reagents (e.g., viral transport media and nucleic acid extraction kits) and the low throughput of the gold-standard molecular detection method (RT-qPCR). While the reagent shortages were eventually resolved, the limited throughput of the RT-qPCR remains a bottleneck for high-throughput testing applications even today. Here, we introduce a rapid saliva-based extraction-free molecular assay, which utilizes a non-invasive saliva sampling and extraction-free sample preparation, a fast endpoint RT-PCR and a high-throughput optical modulation biosensing (ht-OMBi) detection platform. We blindly tested 364 paired nasopharyngeal swabs and saliva samples from suspected SARS-CoV-2 cases in Israel. Compared with the gold standard swab-based RT-qPCR, the presented assay's sensitivity and specificity are 90.7% and 95.3%, respectively, but is achieved with only 50 min. sample-to-result turnaround time (~60% faster than the regular RT-qPCR), allowing high throughput and considerable savings of the reagents and disposables.
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Michael Margulis, Hanan Rohana, Oran Erster, Michal Mandelboim, Asaf Biber, Eli Schwartz, Avi Peretz, and Amos Danielli "Saliva-based extraction-free molecular assay for rapid diagnostics of SARS-CoV-2", Proc. SPIE PC12861, Frontiers in Biological Detection: From Nanosensors to Systems XVI, PC1286108 (13 March 2024); https://doi.org/10.1117/12.3008270
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KEYWORDS
Diagnostics
Viruses
Gold
Biosensing
COVID 19
Modulation
Polymerase chain reaction
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