COVID-19 has become a global problem. There is an urgent need to improve the diagnosisand screening of patients and healthcare workers for COVID-19 in the UK. Mask basedsampling is a method of detecting SARS-COV-2 (the virus responsible for COVID-19) in thebreath of suspected COVID-19 patients or healthcare workers in the mask that they wouldwear in hospital. The investigators have previously demonstrated the utility of thismethod in other respiratory infections, such as tuberculosis.This project aims to investigate the utility of mask-based sampling is a tool for thediagnosis and quantification of COVID-19 in breath and the implications in a healthcaresetting using three cohorts of participants. Initially we will compare the amount ofCOVID-19 detected by mask sampling compared with standard nasopharyngeal swab, which isthe current gold standard test, in patients who present to hospital with COVID-19symptoms.We will address the length of time COVID-19 is breathed out by people affected by thevirus and the how infectious the virus is over time in a cohort of symptomatic healthcareworkers who are isolating at home. This will allow us to understand how long someonestays infectious for and may have the potential to inform public health measures, forinstance when healthcare workers can return to work or duration of isolation. Finally wewill investigate asymptomatic carriage of COVID-19 by different healthcare workers indifferent areas of the hospital during a screening study. This will allow us tounderstand the extent of infection amongst healthcare workers and allow us to addresshospital acquired transmission.
In order to understand the utility of face mask sampling for the diagnosis of COVID-19
and the public health implications, three cohorts of participants will be asked to take
part in this study. Each participant will be asked to wear a modified face mask
containing strips of sampling material for up to one hour and undertake a nasopharyngeal
(nose/throat) swab concurrently. Depending on which cohort the participants are recruited
to, the number of these 'sampling sessions' will vary. Basic demographic and
microbiological data will be collected for every participant.
Cohort 1:
Patients admitted to hospital with COVID-19 symptoms will be approached to undertake a
face mask sample and nasopharyngeal swab at two time points 12 hours apart on a single
day whilst in hospital. Medical records will be accessed for basic clinical, demographic
and microbiological data.
Cohort 2:
Healthcare workers who have report COVID-19 symptoms will be asked to undertake a face
mask sample and nasophayngeal swab on days 1,3,5,7,10,14 and 21 of the study, for part of
which they will be quarantined at home.
During this time they will complete a simple symptom diary. Members of the research team
will visit their home to consent and train them on sampling techniques on day 1. Masks
and swabs will then be left with them to complete.
These samples will then be collected at a mutually convenient time as teh samples are
sample at room temperature for many days. If the healthcare worker does not feel able to
complete self-sampling then a research team member will visit to undertake the sampling.
Full PPE will be worn at all times and Staff working on the study will have NHS honorary
contracts in place and will operate under University Hospitals of Leicester NHS Trust
policies and procedures surrounding infection control and risk assessments whilst
conducting this research. Medical records will be accessed for basic clinical,
demographic and microbiological data. The results of the face mask sample are not
intended to provide any diagnostic results and as such, the results will not be made
available to the participant or the Occupational Health Department and HCWs will be
directed to continue to follow the University Hospitals of Leicester NHS Trust policy
when determining whether or not they are safe and able to return to work.
Cohort 3:
Healthcare workers from different areas of the hospital will be approached as part of a
screening programme. They will be asked to undertake a single face mask and swab sample.
Basic clinical and environmental data will be collected about each participant so they
exposure risk can be stratified. The research team will work closely with the senior
managers of each area to introduce the study to each participant so to minimise any
stigmata related to deciding to participate or not. Any participant that has either a
mask or swab positive result will be followed up and offered conventional screening as
per Public Heath England's guidance. Staff working on the study will have NHS honorary
contracts in place and will operate under University Hospitals of Leicester NHS Trust
policies and procedures surrounding infection control and risk assessments whilst
conducting this research. HCWs will be reminded that the results of the FSM are not
conclusive and should not be used for diagnostic purposes. Each individual who produces a
FSM+ sample will be referred back to the Trust Occupational Health Department for
followup and management as per Trust policy.
Diagnostic Test: Face mask sampling
Mask sampling consists of a modified face mask (flat surgical, duckbilled or FFP1) which
contains up to strips of 3D printed Polyvinyl alcohol (PVA). As outlined in our previous
work (ref lancet). These PVA strips are manufactured by the University of Leicester and
measure approximately 50mm x 500mm and are fixed into place by adhesive pads. Mask
assembly is conducted at the University of Leicester and are sterilised prior to use.
Figure 3 and 4 shows examples of the inside of the mask with 4 strips placed inside and
of how it is worn by study participants. The mask sampling system has been approved for
previous studies in the UK, South Africa and The Gambia and has current approval for
service improvement work at University Hospitals of Leicester NHS Trust for respiratory
pathogens. It is awaiting approval as a medical device with the Medicines and Healthcare
products Regulatory Agency.
Inclusion Criteria:
- Not requiring oxygen by face mask
- Either:
o Patients admitted to hospital with suspected COVID-19
- Or o Healthcare workers working within University Hospitals of Leicester, including
those with and without symptoms suspicious of COVID-19.
Exclusion Criteria:
- Participants requiring oxygen by face mask (i.e., Venturi, non rebreathe)
- Participants with respiratory failure
- Medical history that might, in the opinion of the attending clinician, put the
patient at significant risk if he/she were to participate in the study
- Individuals who are unable to provide informed consent for themselves (i.e.,
individuals who lack capacity).
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Investigator: Manish Pareek
Contact: 0116 2541414
manish.pareek@leicester.ac.uk
Manish Pareek, MBChB PhD
01162541414
manish.pareek@leicester.ac.uk
Caroline Williams, MbChB
cw329@le.ac.uk