Abstract
Managing the pandemic caused by SARS-CoV-2 requires new capabilities in testing, including the possibility of identifying, in minutes, infected individuals as they enter spaces where they must congregate in a functioning society, including workspaces, schools, points of entry, and commercial business establishments. Here, the only useful tests (a) require no sample transport, (b) require minimal sample manipulation, (c) can be performed by unlicensed individuals, (d) return results on the spot in much less than one hour, and (e) cost no more than a few dollars. The sensitivity need not be as high as normally required by the FDA for screening asymptomatic carriers (as few as 10 virions per sample), as these viral loads are almost certainly not high enough for an individual to present a risk for forward infection. This allows tests specifically useful for this pandemic to trade-off unneeded sensitivity for necessary speed, simplicity, and frugality. In some studies, it was shown that viral load that creates forward-infection risk may exceed 105 virions per milliliter, easily within the sensitivity of an RNA amplification architecture, but unattainable by antibody-based architectures that simply target viral antigens. Here, we describe such a test based on a displaceable probe loop amplification architecture.
Highlights
Once again, the world is facing a coronavirus pandemic, this time from SARS-CoV-2 that emerged in Wuhan, China in late 2019 [1]
Previous coronaviral threats include the SARS coronavirus that emerged in southern China in 2003 as the causative pathogen of severe acute respiratory syndrome [2, 3], and a coronavirus that causes Middle East respiratory syndrome (MERS) [4,5,6]
Reverse transcription loop-mediated isothermal amplification (RT-LAMP) has become an alternative to RT-PCR due to its high sensitivity and specificity, its tolerance for inhibitory substances, and operation at constant temperatures. These lower assay complexity and cost, making LAMP often considered for COVID-19 diagnostics [24,25,26]
Summary
The world is facing a coronavirus pandemic, this time from SARS-CoV-2 that emerged in Wuhan, China in late 2019 [1]. Previous coronaviral threats include the SARS coronavirus that emerged in southern China in 2003 as the causative pathogen of severe acute respiratory syndrome [2, 3], and a coronavirus that causes Middle East respiratory syndrome (MERS) [4,5,6]. Unlike these homologous coronaviruses, SARS-CoV-2 creates a remarkable range of medical outcomes, from lethality to mild (or no) symptoms in infected individuals [7, 8]. Antivirals that are effective against other viruses [13] may have activity against SARS-CoV-2 [14], but their ability to manage the pandemic remain in doubt
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