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Review 1: "Hitting the diagnostic sweet spot: Point-of-care SARS-CoV-2 salivary antigen testing with an off-the-shelf glucometer"

This preprint offers a novel diagnostic platform that uses off-the-shelf glucometers to detect SARS-CoV-2 antigens in saliva. The current manuscript offers rigorous validation of the diagnostic technology, but further experiments should be performed before clinical use.

Published onOct 30, 2020
Review 1: "Hitting the diagnostic sweet spot: Point-of-care SARS-CoV-2 salivary antigen testing with an off-the-shelf glucometer"
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Hitting the diagnostic sweet spot: Point-of-care SARS-CoV-2 salivary antigen testing with an off-the-shelf glucometer
Description

Significant barriers to the diagnosis of latent and acute SARS-CoV-2 infection continue to hamper population-based screening efforts required to contain the COVID-19 pandemic in the absence of effective antiviral therapeutics or vaccines. We report an aptamer-based SARS-CoV-2 salivary antigen assay employing only low-cost reagents ($3.20/test) and an off-the-shelf glucometer. The test was engineered around a glucometer as it is quantitative, easy to use, and the most prevalent piece of diagnostic equipment globally making the test highly scalable with an infrastructure that is already in place. Furthermore, many glucometers connect to smartphones providing an opportunity to integrate with contract tracing apps, medical providers, and electronic medical records. In clinical testing, the developed assay detected SARS-CoV-2 infection in patient saliva across a range of viral loads - as benchmarked by RT-qPCR - within one hour, with 100% sensitivity (positive percent agreement) and distinguished infected specimens from off-target antigens in uninfected controls with 100% specificity (negative percent agreement). We propose that this approach can provide an inexpensive, rapid, and accurate diagnostic for distributed screening of SARS-CoV-2 infection at scale.

RR:C19 Evidence Scale rating by reviewer:

  • Strong. The main study claims are very well-justified by the data and analytic methods used. There is little room for doubt that the study produced has very similar results and conclusions as compared with the hypothetical ideal study. The study’s main claims should be considered conclusive and actionable without reservation.

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Review:

Significant barriers to the diagnosis of SARS-CoV-2 infection continue to hamper population-based screening and efforts are required to contain the COVID-19 pandemic in the absence of effective antiviral therapeutics or vaccines. The Authors report an aptamer-based SARS-CoV2 salivary antigen assay employing low-cost reagents ($3.20/test). The test was quantitative and easy to use with the chance of connecting to smartphones providing an opportunity to integrate with contract tracing apps, medical providers, and electronic medical records. In clinical testing, the developed assay detected SARS CoV-2 infection in patient saliva within one hour, with 100% sensitivity and 100% specificity. This approach can provide an inexpensive, rapid, and accurate diagnostic for screening of SARS-CoV-2 infection in clinical settings as well as in mass-population based screening.

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