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.

Association of COVID-19 mortality with politics and on-demand testing in 217 U.S. counties

Background Previous research found increased COVID-19 spread associated with politics and on-demand testing but not in the same study. The objective of this study is to estimate the contribution of each corrected for the other and a variety of known risk factors. Methods Using data from 217 U.S. counties of more than 50,000 population where testing data were available in April, 2021, the associations of COVID-19 deaths with politics, testing and other risk factors were examined by Poisson and least squares regression. Results Statistical controls for 15 risk factors failed to eliminate the association of COVID mortality risk with percent of vote for Donald Trump in 2016 or negative tests per population. Each is independently predictive of increased mortality. Conclusion Apparently, many people who test negative for the SARS-CoV-2 virus engage in activities that increase their risk, a problem likely to increase with the availability of home tests. There is no association of negative tests with the Trump vote but, according to polling data, Trump voters’ past resistance to public health recommendations has been extended to resistance to being vaccinated, threatening the goal of herd immunity.

Empirical evidence to understand the human factor for effective rapid testing against SARS-CoV-2

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antigen point-of-care and home tests are available to laypeople. In four cross-sectional mixed-methods data collections conducted between December 2020 and March 2021 (n = 4,026), we showed that a majority of subjects were willing to test despite mistrust and ignorance regarding rapid tests’ validity. Experimental evidence shows that low costs and access to events could increase testing intentions. Mandatory reporting and isolation after positive results were not identified as major barriers. Instead, assuming that testing and isolation can slow down the pandemic and the possibility to protect others were related to greater willingness to get tested. While we did not find evidence for risk compensation for past tests, experimental evidence suggests that there is a tendency to show less mask wearing and physical distancing in a group of tested individuals. A short communication intervention reduced complacent behavior. The derived recommendations could make rapid testing a successful pillar of pandemic management.

Student experiences of online learning due to Covid-19

Background: Five weeks into the start of a new academic year, the University of Canterbury (UC) in Christchurch, New Zealand experienced a rapid transition from traditional on-campus education to online distance learning. On-campus lectures were replaced by a combination of interactive live-streamed Zoom sessions, pre-recorded classes, compiled videos and laboratory sessions, and other activities. It was unknown how students’ learning was impacted by this sudden change to an online environment. Purpose: Our research sought to explore the main challenges perceived by students in the transition to an online learning environment in order to gain an understanding of how teaching staff can best address student needs in future emergency situations. Methods: A two part survey was electronically distributed to students enrolled in a 4-year engineering programme and a 3-year sport coaching programme at the University of Canterbury. Results: Student responses indicated a clear desire for structured, in-person delivery of tertiary education. The ability to gain rapid feedback from lecturers was missed, as was social interaction and informal learning among peers. The use of timetabled tutorials and small-stakes assessment items helped facilitate regular contact with the course material and interaction among students and between students and teaching staff. Assessment practices which constrained time to respond to questions, although useful in limiting opportunities for cheating, was unpopular with students and was associated with increased anxiety. Students preferred untimed assessments, such as written assignments and take-home tests. In addition, it was found to be important to provide practise opportunities for modified-for-online assessments prior to formal testing to help reduce stress in an already stressful environment.

Point-of-care faecal calprotectin testing in patients with paediatric inflammatory bowel disease during the COVID-19 pandemic

ObjectivesFollowing the disruption of normal paediatric inflammatory bowel disease (IBD) services during the peak of the COVID-19 pandemic, we prospectively audited the first-time use of home faecal calprotectin testing. We aimed to provide an alternative to laboratory tests and to assess the value of home testing as part of our regular services going forward.MethodsHome test kits as well as accompanying user instructions were made available to our patients with paediatric IBD that required faecal calprotectin test between 17 April and 12 August 2020. Once the user completed the test, results were automatically uploaded to the result portal and clinical staff were alerted. A user feedback questionnaire was sent to users that had completed the home test.ResultsOf the 54 patients, 41 (76%) aged between 4.7 and 18.1 years used the home test. A total of 45 home tests were done, one of which produced an invalid result. The decision to modify management was made in 12 (29%) of the patients, while 14 (34%) had no changes made and 15 (37%) required further assessment. Twenty (48.8%) responded to the questionnaire and 85% stated that they preferred the home test to the laboratory testing method.ConclusionsHome calprotectin tests were useful in guiding clinical management during a time when laboratory testing was less available. They may offer benefits as part of routine paediatric IBD monitoring to help target appointments and reduce unnecessary hospital attendances in the future.

Unpacking the black box: Empirical evidence to understand the human factor for effective rapid testing against SARS-CoV2

SARS-CoV-2 rapid antigen point-of-care (PoC) and home tests are available to laypeople. This raises questions regarding the drivers and barriers of people’s willingness to use tests, their understanding of test results and the psychological and behavioural consequences of positive and negative test results. Four cross-sectional data collections, including survey items, open text answers and three experiments, were therefore conducted between December 2020 and March 2021, involving 4,026 German participants. The majority was willing to use PoC or home tests. People will be more likely to use tests when they are inexpensive and easy to use or when they are a necessary (given low infection rates) for obtaining access to public and social life. However, people urgently need information about what a test result means and how they should behave. Recommendations based on the present findings could make rapid testing a successful pillar of pandemic management.

A Remote Household-Based Approach to Influenza Self-Testing and Antiviral Treatment

BackgroundHouseholds represent important settings for transmission of influenza and other respiratory viruses. Current influenza diagnosis and treatment relies upon patient visits to healthcare facilities, which may lead to under-diagnosis and treatment delays. This study aimed to assess the feasibility of an at-home approach to influenza diagnosis and treatment via home testing, telehealth care, and rapid antiviral home delivery.MethodsWe conducted a pilot interventional study of remote influenza diagnosis and treatment in Seattle-area households with children during the 2019-2020 influenza season using pre-positioned nasal swabs and home influenza tests. Home monitoring for respiratory symptoms occurred weekly; if symptoms were reported within 48 hours of onset, participants collected mid-nasal swabs and used a rapid home-based influenza immunoassay. An additional home-collected swab was returned to a laboratory for confirmatory influenza RT-PCR testing. Baloxavir antiviral treatment was prescribed and delivered to symptomatic and age-eligible participants, following a telehealth encounter.Results124 households comprising 481 individuals self-monitored for respiratory symptoms, with 58 home tests administered. 12 home tests were positive for influenza, of which 8 were true positives confirmed by RT-PCR. The sensitivity and specificity of the home influenza test was 72.7% and 96.2%, respectively. There were 8 home deliveries of baloxavir, with 7 (87.5%) occurring within 3 hours of prescription, and all within 48 hours of symptom onset.ConclusionsWe demonstrate the feasibility of self-testing combined with rapid home delivery of influenza antiviral treatment. This approach may be an important control strategy for influenza epidemics and pandemics.SummaryIn this pilot study, 481 individuals self-monitored for respiratory symptoms. Of 58 home tests, 12 were influenza-positive. There were 8 baloxavir home deliveries within 48 hours of illness onset. A home-based approach to influenza diagnosis and treatment could be feasible.