Requirements and study designs for US regulatory approval of influenza home tests

Home testing for infectious disease has come to the forefront during the COVID-19 pandemic. There is now considerable commercial interest in developing complete home tests for a variety of viral and bacterial pathogens. However, the regulatory science around home infectious disease test approval, and procedures test manufacturers and laboratory professionals will need to follow, have not yet been formalized by US FDA, with the exception of EUA guidance for COVID-19 tests. We describe the state of home-based testing for influenza with a focus on sample-to-result home tests, discuss the various regulatory pathways by which these products can reach populations, and provide recommendations for study designs, patient samples, and other important features necessary to gain market access. These recommendations have potential application for home use tests being developed for other viral respiratory infections, such as COVID-19, as guidance moves from EUA designation into 510(k) requirements.

At-home testing to mitigate community transmission of SARS-CoV-2: protocol for a public health intervention with a nested prospective cohort study

Background The COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve as a global health crisis. Although highly effective vaccines have been developed, non-pharmaceutical interventions remain critical to controlling disease transmission. One such intervention—rapid, at-home antigen self-testing—can ease the burden associated with facility-based testing programs and improve testing access in high-risk communities. However, its impact on SARS-CoV-2 community transmission has yet to be definitively evaluated, and the socio-behavioral aspects of testing in underserved populations remain unknown. Methods As part of the Rapid Acceleration of Diagnostics–Underserved Populations (RADx-UP) program funded by the National Institutes of Health, we are implementing a public health intervention titled “Say Yes! COVID Test” (SYCT) involving at-home self-testing using a SARS-CoV-2 rapid antigen assay in North Carolina (Greenville, Pitt County) and Tennessee (Chattanooga City, Hamilton County). The intervention is supported by a multifaceted communication and community engagement strategy to ensure widespread awareness and uptake, particularly in marginalized communities. Participants receive test kits either through online orders or via local community distribution partners. To assess the impact of this intervention on SARS-CoV-2 transmission, we will conduct a non-randomized, ecological study using community-level outcomes. Specifically, we will evaluate trends in SARS-CoV-2 cases and hospitalizations, SARS-CoV-2 viral load in wastewater, and population mobility in each community before, during, and after the SYCT intervention. Individuals who choose to participate in SYCT will also have the option to enroll in an embedded prospective cohort substudy gathering participant-level data to evaluate behavioral determinants of at-home self-testing and socio-behavioral mechanisms of SARS-CoV-2 community transmission. Discussion This is the first large-scale, public health intervention implementing rapid, at-home SARS-CoV-2 self-testing in the United States. The program consists of a novel combination of an at-home testing program, a broad communications and community engagement strategy, an ecological study to assess impact, and a research substudy of the behavioral aspects of testing. The findings from the SYCT project will provide insights into innovative methods to mitigate viral transmission, advance the science of public health communications and community engagement, and evaluate emerging, novel assessments of community transmission of disease.

Durham University students’ experiences of asymptomatic COVID-19 testing: a qualitative study

ObjectivesTo evaluate the asymptomatic coronavirus testing programme at Durham University by exploring students’ barriers and facilitators to taking part and provide recommendations to improve the programme.DesignQualitative interviews.SettingOnline.Participants30 students enrolled at Durham University were interviewed in March 2021.Main outcome measuresAttitudes towards testing, experiences of testing and barriers and facilitators to engaging in testing at Durham University.ResultsKey motivations for testing included protecting oneself and others and accessing facilities and events. The process of booking, accessing and doing a test was mostly easy and convenient, although some may prefer home testing. There were concerns about the accuracy of tests and the implications of a positive result. Some highlighted they might be less likely to engage in testing if vaccinated. A negative test result provided confidence to engage in their daily activities, while encouraging some to socialise more.ConclusionsThe findings show that the testing programme at Durham University is convenient and well organised, with testing as a potential requirement to access social events, and self-isolation support being key contributor to uptake. These findings provide insights into young adults’ attitudes towards testing and can inform testing programmes in other universities and settings with asymptomatic testing programmes.

Barriers To and Strategies To Address COVID-19 Testing and Testing Hesitancy: A Rapid Scoping Review

Background: Testing is a foundational component of any COVID-19 management strategy; however, emerging evidence suggests that barriers and hesitancy to COVID-19 testing may affect uptake or participation and often these are multiple and intersecting factors that may vary across population groups. To this end, Health Canada’s COVID-19 Testing and Screening Expert Advisory Panel commissioned this rapid review in January 2021 to explore the available evidence in this area. The aim of this rapid review was to identify barriers to COVID-19 testing and strategies used to mitigate these barriers. Methods: Searches (completed January 8 2021) were conducted in MEDLINE, Scopus, medRxiv/bioRxiv, Cochrane and online grey literature sources to identify publications that described barriers and strategies related to COVID-19 testing. Results: From 1294 academic and 97 grey literature search results, 31 academic and 31 grey literature sources were included. Data were extracted from the relevant papers. The most commonly cited barriers were: cost of testing; low health literacy; low trust in the healthcare system; availability and accessibility of testing sites; and stigma and consequences of testing positive. Strategies to mitigate barriers to COVID-19 testing included: free testing; promoting awareness of importance to testing; presenting various testing options and types of testing centres (i.e., drive-thru, walk-up, home testing); providing transportation to testing centres; and offering support for self-isolation (e.g., salary support or housing). Conclusion: Various barriers to COVID-19 testing and strategies for mitigating these barriers were identified. Further research to test the efficacy of these strategies is needed to better support testing for COVID-19 by addressing testing hesitancy as part of the broader COVID-19 public health response