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.
Rapid, highly sensitive, and high-throughput detection of biomarkers at low concentrations is invaluable for early diagnosis of various diseases. In many sensitive immunoassays the protocol is time consuming and requires a complicated and expensive detection system. Here, we demonstrate a high-throughput optical modulation biosensing (ht-OMB) system, which enables reading a 96-well plate within 10 minutes. Using the system, to detect human Interleukin-8, we demonstrated a limit of detection of 0.14 ng/L and a 4-log dynamic range. Testing 94 RNA extracts from 36 confirmed RT-qPCR SARS-CoV-2-positive patients (C_t≤40) and 58 confirmed RT-qPCR SARS-CoV-2-negative individuals resulted in 100% sensitivity and 100% specificity.
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