icf: face masking sampling technologies for use with rapid diagnostic tests

Following evidence that SARS-CoV-2 could be transmitted pre-symptomatically via exhaled particles, Professor Baron Peter Piot, former director of the London School of Hygiene and Tropical Medicine, was quoted as saying, "SARS-CoV-2 testing via breath sample coupled with an ultrafast molecular analysis would be game-changing since it would allow for the timely detection of individuals who are most likely to transmit the virus. Because a breath sample is much less invasive compared to swabs or saliva, it would also allow for more frequent testing and a faster return to normal." This quotation encapsulates the potential of using exhaled breath samples for diagnostic applications, which is the theme of our proposal. Here, we plan to develop and integrate exhaled breath particle capture technology into facemasks. To enable this, we will collaborate with our first industrial partner, ModlaPPE, who are developing novel reusable facemasks with recyclable filters. Furthermore, we will develop work-flows (a set of simple steps) that allow the captured sample to be used with traditional lateral flow-based rapid diagnostic tests, RDTs (and future, more sensitive, molecular versions) for the detection of infectious respiratory diseases. For this, we will collaborate with a second industrial partner, the diagnostics developer Global Access Diagnostics (formerly Mologic). Specifically, we aim to develop fit-for-purpose prototypes for two simple exhaled breath capture devices, which can be integrated into facemasks and that are compatible with infectious respiratory disease RDTs, including COVID-19, influenza and respiratory syncytial virus, RSV. Objectives include: Developing working prototypes for one "dry" (filter-based) and one "liquid" (condensation-based) facemask integrated, exhaled breath capture devices, working closely with ModlaPPE Demonstrating that the devices are able to capture (inactivated) SARS-CoV-2 virus-containing droplets/aerosols with sufficient efficiency to enable detection by RDTs (and by laboratory-based immunoassays and RT-PCR assays for "gold standard" comparison) Demonstrating compatibility with RDTs produced by Global Access Diagnostics and developing work-flows that allow processing of the captured sample, with minimal manipulations (e.g. by developing simple methods for introducing the captured sample into RDTs and looking at extraction buffer requirements) Engaging with stakeholders and end users to provide feedback to firstly improve the prototypes and secondly to improve future uptake of the collection devices At the end of this proposal, we'd expect to have a least one optimised prototype breath collection device that can be taken to the next step of the development process, which in this case would be preliminary clinical studies to demonstrate that the collection device works to a similar degree as more invasive sampling methods. As noted above, this technology is far less invasive than the use of swabs and, arguably, will be better at identifying individuals that are in the active process of transmitting infectious respiratory pathogens. These characteristics suggest utility with for example i) children, who may not allow invasive swab samples to be taken, ii) healthcare workers, who have to undergo multiple rounds of testing and would prefer a non-invasive process, and iii) asymptomatic or presymptomatic individuals that may be infectious but unaware that they are.