CovidNudge SARS-CoV-2 Test v1
Authors: not provided Maria 
Published: December 2020

Protocol for performing a CovidNudge test for SARS-CoV-2. CovidNudge is a near-patient, automated, lab-free, point-of-care diagnostic test for SARS-CoV-2 with 97% sensitivity and 100% specificity when compared to gold-standard laboratory-based RT-PCR. The key advantages of this end-to-end, sample-to-result technology are (i) no sample handling - a diagnostic swab (nasopharyngeal or phlegm) is placed directly into the cartridge and sealed before analysis, removing the need for pipetting and any laboratory, (ii) rapid point of care diagnosis (approx. 90mins in a self-contained analysis box), (iii) it can be operated with minimal expertise and is fully portable, (iv) an internal control for human RNA to assess the quality of sample, (v) it multiplexes a number of reactions to achieve high sensitivity and, most importantly as prevalence of infection falls, specificity, (vi) the results become available immediately upon test completion- results output can be directly plugged into various platforms and software solutions, and (vii) phlegm samples of up 10 individuals can be pooled and run on the same cartridge reducing testing cost to less than $3.50 per sample and reducing significantly processing time, making it an ideal application for community testing. The system consists of a DnaCartridge, a NudgeBox, remote (Cloud) software and an Operator app for running tests and viewing the results. The system requires the use of single-use disposable CovidNudge cartridges that hold the RT-PCR reagents and host the RT-PCR process. In contrast to other rapid tests which still require viral transport medium and a simple sample transfer step, swabs are loaded directly into a fully sealed cartridge which allows safe testing outside of laboratory, including primary care and community settings. Because the cartridges are self-contained, cross-contamination between samples is minimized. Multiplexed assays within the cartridge allow inclusion of a positive human control, which reduces the false negative testing rate due to insufficient sampling. The DnaNudge Cloud can be configured to transfer patient results securely to authorised organisations. The results can also be retrieved securely by authorised organisations. Depending on the hosting organisation’s requirements and IT systems, following options are available: · Integration with PointOfCare (POC) middleware solutions · Bespoke hospital integrations (e.g. through TIE) · Third-party notification services (e.g. Email, SMS) With the system integration in place, results can be available in the organisation's POC solution and/or electronic records system via the DnaNudge proprietary mobile health network. Since May 2020, the system has been implemented in UK hospitals and is currently being rolled out nationwide to more than 500 healthcare settings, with a significant order from the UK Government and the Department of Health and Social Care for 5,800,000 tests for COVID-19. A paper “Assessing a novel, lab-free, point-of-care test for SARS-CoV-2 (CovidNudge): a diagnostic accuracy study”, has been published at The Lancet Microbe: https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30121-X/fulltext