Abstract
Background: England, UK has one of the highest rates of confirmed COVID-19 mortality globally. Until recently, testing for the SARS-CoV-2 virus focused mainly on healthcare and care home settings. As such, there is far less understanding of community transmission. Protocol: The REal-time Assessment of Community Transmission (REACT) programme is a major programme of home testing for COVID-19 to track progress of the infection in the community. REACT-1 involves cross-sectional surveys of viral detection (virological swab for RT-PCR) tests in repeated samples of 100,000 to 150,000 randomly selected individuals across England. This examines how widely the virus has spread and how many people are currently infected. The age range is 5 years and above. Individuals are sampled from the England NHS patient list. REACT-2 is a series of five sub-studies towards establishing the seroprevalence of antibodies to SARS-CoV-2 in England as an indicator of historical infection. The main study (study 5) uses the same design and sampling approach as REACT-1 using a self-administered lateral flow immunoassay (LFIA) test for IgG antibodies in repeated samples of 100,000 to 200,000 adults aged 18 years and above. To inform study 5, studies 1-4 evaluate performance characteristics of SARS-CoV-2 LFIAs (study 1) and different aspects of feasibility, usability and application of LFIAs for home-based testing in different populations (studies 2-4). Ethics and dissemination: The study has ethical approval. Results are reported using STROBE guidelines and disseminated through reports to public health bodies, presentations at scientific meetings and open access publications. Conclusions: This study provides robust estimates of the prevalence of both virus (RT-PCR, REACT-1) and seroprevalence (antibody, REACT-2) in the general population in England. We also explore acceptability and usability of LFIAs for self-administered testing for SARS-CoV-2 antibody in a home-based setting, not done before at such scale in the general population.
Highlights
England, UK has one of the highest rates of confirmed COVID-19 mortality globally
The design and language used in the instructional video and booklet, and the decision on the type and number of lancets supplied and the type and use of pipette included in the lateral flow immunoassay (LFIA) kits for a larger population-based usability study are informed by this initial public involvement and user testing phase of REal-time Assessment of Community Transmission (REACT)-2
The REACT programme is a series of studies that are seeking to improve understanding of how the COVID-19 pandemic is progressing across England
Summary
University of Liverpool, Any reports and responses or comments on the article can be found at the end of the article. The design and language used in the instructional video and booklet, and the decision on the type and number of lancets supplied and the type and use of pipette included in the LFIA kits for a larger population-based usability study (study 3 below) are informed by this initial public involvement and user testing phase of REACT-2. The decision to proceed with an LFIA, and which one, for the large-scale national seroprevalence study (study 5) will be based on a number of criteria including the usability and acceptability determined in this study, a relatively low proportion of invalid results, a high concordance with clinicianread results, together with test performance in the laboratory evaluation of clinical samples (study 1). We work with our Public Advisory Panel to identify and produce materials, including infographics and blogs, to disseminate our findings to non-academic audiences and the general public
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