You & type 2 @ home: Testing a fully remote model for diabetes annual reviews using the you & type 2 personalised care and support planning pathway in combination with remote monitoring technologies at two primary care practices in South London

Aims: A proof-of- concept pilot investigating the profile of person who engaged with remote testing for their annual diabetes review, and service user (SU) and primary care practice acceptability for completing annual diabetes review tests remotely (blood pressure, finger-stick blood test and urine test). Method(s): A mixed methods evaluation based on SU surveys sent to all 144 pilot participants, semi-structured SU and staff interviews, and demographic and clinical data extraction from primary care electronic patient record system. Result(s): Profile: The pathway was considered suitable for people who were working, digitally capable, younger, had household support to complete the tests, had non-complex diabetes, or a combination of these attributes. It was deemed less suitable for the very elderly, the less digitally capable, those with complex health needs or socially isolated. SU Acceptability: Interviewees and survey respondents overall deemed the remote tests acceptable for use. Convenience and reduced exposure to Covid-19 were motivating factors for participation. Preference for face-to- face care or concerns around using digital technologies were key reasons for decline. Staff Acceptability: The pathway was deemed acceptable and was successfully implemented at both practices. Support from a designated pathway co-ordinator and project manager were key factors linked to acceptability and success. The remote pathway was seen as an opportunity to reduce primary care pressures on in-person care. Conclusion(s): It is possible to successfully conduct annual diabetes reviews remotely. Although not appropriate nor desirable to everyone, remote testing provides a viable alternative to in-person testing for certain individuals.

Cost-Effectiveness of Non-Pharmaceutical Interventions (NPI), Vaccines and the Combination of NPI and Vaccines in Managing the COVID Pandemic

Objectives: We estimated the cost-effectiveness of non-pharmaceutical interventions (NPI), vaccines, and the combination of NPI and vaccines in managing the COVID pandemic. Method(s): A dynamic transmission model was constructed to simulate the incidence of COVID infections and deaths among community-dwelling Singapore residents. Using this model, we compared the cost and outcomes of NPI (border control measures, safe distancing and mask wearing) versus no NPI in an unvaccinated and a vaccinated population. The analysis was conducted from the societal perspective over a one year time horizon, with data based on the COVID situation in Singapore during Jan 2021 to Dec 2021. Costs of vaccination, adverse events, masks, self-testing using rapid antigen tests, test-trace-isolate (TTI), outpatient visits, hospitalization, productivity loss and reduced sales receipt from retail and food and beverages industries were included. Health loss from adverse events, TTI and COVID infection and deaths were also included. Result(s): Among the scenarios compared, vaccination combined with NPIs yield the lowest cost (S$7.6 billion), while no vaccination with NPIs had the highest costs (S$49.1 billion). The largest loss in QALYs from the population was seen from the scenario without vaccination or NPIs. Using a dominance approach, vaccination combined with NPIs is cost saving with an ICER of -S$213 billion per QALY, compared to no vaccination with lockdown measures. The results show that NPIs alone without vaccination only delays transmission, but does not significantly change the total number of cases observed in the population. Vaccination is both cost saving and health saving as the difference in cases averted from vaccination and their associated costs, is far greater than the additional costs required to vaccinate the public. Conclusion(s): Both vaccination and NPI are critical strategies for managing the COVID pandemic. In the presence of vaccine, NPIs continue to offer benefits in terms of reduced number of infections and deaths.Copyright © 2023

Secondary distribution of HIV self-test kits by HIV index and antenatal care clients: implementation and costing results from the STAR Initiative in South Africa.

BACKGROUND: Partner-delivered HIV self-testing kits has previously been highlighted as a safe, acceptable and effective approach to reach men. However, less is known about its real-world implementation in reaching partners of people living with HIV. We evaluated programmatic implementation of partner-delivered self-testing through antenatal care (ANC) attendees and people newly diagnosed with HIV by assessing use, positivity, linkage and cost per kit distributed. METHODS: Between April 2018 and December 2019, antenatal care (ANC) clinic attendees and people or those newly diagnosed with HIV clients across twelve clinics in three cities in South Africa were given HIVST kits (OraQuick Rapid HIV-1/2 Antibody Test, OraSure Technologies) to distribute to their sexual partners. A follow-up telephonic survey was administered to all prior consenting clients who were successfully reached by telephone to assess primary outcomes. Incremental economic costs of the implementation were estimated from the provider's perspective. RESULTS: Fourteen thousand four hundred seventy-three HIVST kits were distributed - 10,319 (71%) to ANC clients for their male partner and 29% to people newly diagnosed with HIV for their partners. Of the 4,235 ANC clients successfully followed-up, 82.1% (3,475) reportedly offered HIVST kits to their male partner with 98.1% (3,409) accepting and 97.6% (3,328) using the kit. Among ANC partners self-testing, 159 (4.8%) reported reactive HIVST results, of which 127 (79.9%) received further testing; 116 (91.3%) were diagnosed with HIV and 114 (98.3%) initiated antiretroviral therapy (ART). Of the 1,649 people newly diagnosed with HIV successfully followed-up; 1,312 (79.6%) reportedly offered HIVST kits to their partners with 95.8% (1,257) of the partners accepting and 95.9% (1,206) reported that their partners used the kit. Among these index partners, 297 (24.6%) reported reactive HIVST results of which 261 (87.9%) received further testing; 260 (99.6%) were diagnosed with HIV and 258 (99.2%) initiated ART. The average cost per HIVST distributed in the three cities was US$7.90, US$11.98, and US$14.81, respectively. CONCLUSIONS: Partner-delivered HIVST in real world implementation was able to affordably reach many male partners of ANC attendees and index partners of people newly diagnosed with HIV in South Africa. Given recent COVID-19 related restrictions, partner-delivered HIVST provides an important strategy to maintain essential testing services.

An Online Intervention Promoting HIV Testing Service Utilization Among Chinese men who have sex with men During the COVID-19 Pandemic: A quasi-experimental Study.

The COVID-19 pandemic created disruptions in HIV testing service utilization among men who have sex with men (MSM). The present study was to evaluate the effectiveness of an online health promotion program implemented by a community-based organization (CBO) in increasing the uptake of any type of HIV testing and home-based HIV self-testing (HIVST) over a six-month follow-up period. Participants of an observational prospective cohort study conducted during the same period served as the comparison group. This study was conducted between September 2020 and December 2021. Participants were Chinese-speaking adult MSM who were HIV-negative/unknown sero-status recruited through multiple sources in Hong Kong, China. Participants in the intervention group were exposed to the following health promotion components: (1) viewing an online video promoting HIVST, (2) visiting the project webpage, and (3) having access to a chargeable HIVST service implemented by the CBO. Among 400 and 412 participants in the intervention group and the comparison group, 349 (87.3%) and 298 (72.3%) completed follow-up evaluation at Month 6. Multiple imputation was used to replace missing values. At Month 6, participants in the intervention group reported significantly higher uptake of any type of HIV testing (57.0% versus 49.0%, adjusted odds ratios [AOR]: 1.43, p = .03) and HIVST (25.8% versus 14.8%, AOR: 2.04, p = .001), as compared to those in the comparison group. Process evaluation of the health promotion components for the intervention group was positive. Promoting HIVST is a potentially useful strategy to increase HIV testing service utilization among Chinese MSM during the pandemic.

Rapid and Sensitive Diagnosis of COVID-19 Using an Electricity-Free Self-Testing System.

Rapid and sensitive detection of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is essential for early diagnosis and effective treatment. Nucleic acid testing has been considered the gold standard method for the diagnosis of COVID-19 for its high sensitivity and specificity. However, the polymerase chain reaction (PCR)-based method in the central lab requires expensive equipment and well-trained personnel, which makes it difficult to be used in resource-limited settings. It highlights the need for a sensitive and simple assay that allows potential patients to detect SARS-CoV-2 by themselves. Here, we developed an electricity-free self-testing system based on reverse transcription loop-mediated isothermal amplification (RT-LAMP) that allows for rapid and accurate detection of SARS-CoV-2. Our system employs a heating bag as the heat source, and a 3D-printed box filled with phase change material (PCM) that successfully regulates the temperature for the RT-LAMP. The colorimetric method could be completed in 40 min and the results could be read out by the naked eye. A ratiometric measurement for exact readout was also incorporated to improve the detection accuracy of the system. This self-testing system is a promising tool for point-of-care testing (POCT) that enables rapid and sensitive diagnosis of SARS-CoV-2 in the real world and will improve the current COVID-19 screening efforts for control and mitigation of the pandemic.

Evidence and regulation for COVID-19 self-tests

Introduction: The development of new diagnostic tests for SARS-CoV-2 is a strategic component for the prevention and control of COVID-19. To regulate the market for SARS-CoV-2 antigen detection self-tests, the regulatory agency issued a resolution that provided for the introduction of self-tests in Brazil. Objective: To perform a comparison between the new technical requirements of antigen self-tests for COVID-19 with data and information available in the literature. Method: This is a systematic literature review to carry out a comparative study between the scientific evidence and the new technical requirements for the commercialization of antigen self-tests for COVID-19 in Brazil. The search was performed in October 2021, and updated in January 2022. Results: Of the 517 studies identified, nine were included. The studies reported adequate sensitivity and specificity results for most self-tests performed in symptomatic people. The studies bring a variety of tests available and one of them was registered for commercialization in Brazil. Based on this outcome, national regulation follows standards that favor the promotion of self-monitoring by the population, which can contribute to a public health policy. Conclusions: The technical requirements contained in the new regulation and at the national level are consistent with the evidence found, which ensures reliability for decision-making by consumers, clinicians and service providers. It is necessary to continue with studies on self-test coverage for new variants, biological material disposal policies and how the use of self-tests can contribute to the role of consumers in health surveillance actions.

Feasibility and Acceptability of Self-Collected Rapid Antigen Tests in the Community and at Home

Intro: Uptake of SARS-CoV-2 rapid antigen tests (RATs) for self-testing has been high following authorisation by the Australian Therapeutic Goods Administration (TGA). However, there are no published Australian data assessing feasibility and compliance with home-based rapid antigen testing. The aim of this study was to determine the acceptability of daily rapid antigen self-testing. Method(s): We prospectively recruited a cohort of hospital employees and students from primary and secondary school to perform daily self-testing using RATs in the home over 14 consecutive days. Participants consenting to the study were supplied with 15 Roche SARS-CoV-2 Antigen Nasal Self Tests, 3 saliva swabs for self-collection for RT-PCR and were asked to record results and answer a daily survey using a smartphone application. Finding(s): 38% (26/68) of the cohort were compliant to 14 consecutive days of testing;this was significantly higher in students (71%) than hospital employees (28%). The median number of tests performed over 14 consecutive days was 11 and time to first missed test was a median 5.5 days. The most common reasons for missing days were "I forgot" (37.5%) and "too busy" (8.9%). Ease of self- nasal swabbing, self-nasal testing. performing the test and using the app were rated as comfortable/very comfortable in over 80% of the cohort. Discussion(s): Most study participants in this Australian cohort were compliant with frequent home-based RATs. By study end most participants (93.8%) found the testing process acceptable/very acceptable. There is need for further work on the cost-effectiveness and impact of self-tested RATs under a range of specific uses and conditions. Conclusion(s): This study provided valuable information on acceptability and feasibility of regular home-based testing which could be applied to other diseases. Ongoing community engagement with clear information on RATs including accuracy and use cases is important for decision-making and addressing concerns, particularly for linguistically diverse peoples.Copyright © 2023

Hiv Self-Testing in Vietnam: From Pilot to Scale Up

While the World Health Organization strongly recommends HIV self-testing (HIVST) as an approach to HIV testing services, scale up has been minimal in low- and middle-income countries. Vietnam has successfully delivered HIVST at scale for key populations (KP), including men who have sex with men, transgender women, people who inject drugs, female sex workers and their partners. We reviewed data from the USAID/PATH Healthy Markets (2014-2021), including consumer surveys, HIVST usability and performance assessments, and service data to summarize the five stages of HIVST scale-up in Vietnam: 1) Assessing HIVST acceptability, preferences, and willingness to pay (WTP);2) Piloting HIVST;3) Developing HIVST policies and assessing products;4) Facilitating HIVST market authorization;and 5) Implementing differentiated service models. A '5A' approach was employed to shape HIVST markets, i.e., improving affordability, enhancing availability, assuring quality, ensuring appropriate design, and boosting awareness and demand. We assessed key factors related to HIVST supply and demand. In terms of supply, the median price people were willing to pay was US$4.3 per test. HIVST products with stringent regulatory approval successfully obtained free sale certificate registration, and blood-based HIVST products were highly accurate (99%-99.8%). Differentiated HIVST distribution models played a significant role in scaling-up HIVST and ensuring uninterrupted access to essential HIV services, e.g., pre-exposure prophylaxis monitoring during COVID-19 lock-downs. Related to demand and testing uptake, the majority of KPs accessing HIVST were first time HIV testers. Creative online-to-offline behavior change communication increased client awareness, trust, and use of HIVST. HIVST was successful in reaching first-time testers who may not otherwise test or seek facility-based care. HIVST is an effective strategy for reaching undiagnosed individuals and is accepted and preferred by KPs. HIVST scale-up requires enabling policy, intensive demand generation efforts, and differentiated service models.Copyright © 2023

Human-Centered Design in Response to a Pandemic: A Health System and Innovation Center Collaboration

Purpose of Study In the spring of 2020, the coronavirus pandemic brought new challenges to healthcare systems as the rising demand for protective equipment led to product and resource inequalities around the globe. The inability to safeguard workers led to increased infection rates and deaths of healthcare professionals worldwide. The purpose of this study is to evaluate the response of an in-house innovation committee to meet the unforeseen needs faced by healthcare systems during an acute medical crisis. Methods Used Housed directly within the University of Utah's health system (U Health), The Center for Medical Innovation (CMI) teamed up with the hospital's administration, BME, COVID task force, and occupational health to create an innovative think-tank to tackle the challenges brought in by the coronavirus pandemic, with the purpose of stratifying clinical needs based upon acuity, frequency, and urgency. While prioritizing equipment needs, CMI used human-centered design to analyze common industry practices, engineer comparable solutions from commercially available materials, test reimagined products against known gold-standards, and create open-source assembly guides that allowed others facing similar shortages to do the same. Summary of Results The close-working relationship between CMI and U Health allowed for the rapid identification, innovation, and engineering of products that met the needs of healthcare workers during the months following the COVID pandemic. Many of these were directly adopted in clinical settings, including aerosol containment tents, powered air-purifying respirators, and self-testing stations. Additionally, CMI identified and engineered 20 additional readily producible, rapid-response products in anticipation of future needs, such as a bubble CPAP, containment boxes, and re-usable PPE. From these, dozens of open source, 'Improvised Personal Protective Equipment' manuals were shared with global partners to address the inequality of medical equipment in lowresource settings. Conclusions The rapid development of easily-producible, lowcost solutions for acute clinical needs-especially those faced by the equipment shortages seen during a pandemic-is improved via the partnership between health systems and a center for medical innovation.

Covid-19 Self-Testing among Healthcare Workers and General Population in Malawi

Background: COVID-19 testing is critical for identifying cases to prevent transmission. SARS-CoV-2 self-testing has the potential to increase diagnostic testing capacity and to expand access to hard-to-reach areas in low-andmiddle- income countries. We investigated the feasibility and acceptability of COVID-19 self-sampling and self-testing using SARS-CoV-2 Ag-Rapid Diagnostic Tests. Method(s): Between July 2021 to February 2022, we conducted a mixedmethods cross-sectional study examining self-sampling and self-testing using Standard Q and Panbio COVID-19 Ag Rapid Test Device in Urban and rural Blantyre, Malawi. Health care workers and adults (18y+) in the general population were systematically sampled. Result(s): Overall, 1,330 participants were enrolled of whom 674 (56.0%) were female with 664 for self-sampling and 666 for self-testing. Overall mean age was 30.7y (standard deviation [SD] 9.6). Self-sampling usability threshold for Standard Q was 273/333 (82.0%: 95% CI 77.4% to 86.0%) and 261/331 (78.8%: 95% CI 74.1% to 83.1%) for Panbio. Self-testing threshold was 276/335 (82.4%: 95% CI 77.9% to 86.3%) and 300/332 (90.4%: 95% CI 86.7% to 93.3%) for Standard Q and Panbio, respectively. Agreement between self-sample results and professional test results was 325/325 (100%) and 322/322 (100%) for Standard Q and Panbio, respectively. For self-testing, agreement was 332/333 (99.7%: 95% CI 98.3 to 100%) for Standard Q and 330/330 (100%: 95% CI 99.8 to 100%) for Panbio. Odds of achieving self-sampling threshold increased if the participant was recruited from an urban site (odds ratio [OR] 2.15 95% CI 1.44 to 3.23, P < .01. Compared to participants with primary school education those with secondary and those with tertiary achieved higher self-testing threshold OR 1.88 (95% CI 1.17 to 3.01), P = .01 and 4.05 (95% CI 1.20 to13.63), P = .02, respectively. Conclusion(s): One of the first studies to demonstrate high feasibility of self-testing using SARS-CoV-2 Ag-RDTs in low- and middle-income countries potentially supporting large scale-up.

Cost-Effectiveness of Workplace Covid-19 Self-Testing: A Mathematical Modeling Study

Background: As COVID-19 cases persist, one potential intervention to reduce absenteeism in the workplace due to COVID-19 is to use rapid antigen diagnostics to mitigate the spread of SARS-CoV-2. Furthermore, routine testing in the workplace offers an avenue to reaching a large proportion of the population which could lead to a greater community impact beyond solely mitigating transmission events that occur in the workplace. We sought to identify the most cost-effective workplace testing strategies at the community level and within individual workplaces. Method(s): We used two models to understand how SARS-CoV-2 AgRDTs could best be implemented within the workplace to mitigate the spread of COVID-19. In our community-level dynamic transmission model, PATAT, we evaluated the impact of symptomatic testing and asymptomatic testing of a fixed proportion of the formally employed workforce on broader community transmission. We stratified runs by asymptomatic testing frequency, vaccine coverage, vaccine effectiveness, and Rt. Simulations were informed using demographic data from Georgia, Brazil, and the Netherlands. We conducted a cost-effectiveness analysis using the results from each country and assumed a $2.50 total cost per test. Result(s): We observed a substantial decrease in the number of infections occurring in both the workplace and community when a SARS-CoV-2 AgRDTs strategy was implemented. Under all conditions, mandatory symptomatic testing and related quarantine from the workplace averted up to 72%, 79%, and 74% of community infections in Brazil, Georgia, and the Netherlands respectively. Limiting tests to symptomatic workers was always on the cost-effectiveness frontier, regardless of the vaccine coverage, efficacy, or Rt of the virus (Figure 1), at $2-$4 per workplace infection prevented. While asymptomatic testing was on the cost-effectiveness frontier, it would cost an additional $500-$6700 to prevent one additional workplace infection. The added benefit of routine asymptomatic testing was minimal until 100% of the workforce was reached. Conclusion(s): We found self-testing with AgRDTs for the formally employed workforce is both efficient at reducing workplace and community infections as well as cost-effective when targeting symptomatic individuals. Willingness to pay to avoid workplace absenteeism may differ by country, individual workplaces, and the perceived economic value of several workdays missed. If there is a higher willingness to pay, routine asymptomatic screening may be considered.

Development and Utilization of an at Home Urine Exosome Biomarker Collection Test Kit to Support Urologic Telehealth

INTRODUCTION AND OBJECTIVE: COVID-19 led to paradigm shifts in telemedicine due to patient's fear of office visits and travel avoidance. With widespread cancellation of office visits and reduction of diagnostic biopsy procedures in men with elevated PSAs, the need for a non-invasive/non-DRE At Home Collection Kit for assessing risk of aggressive prostate cancer and to prioritize biopsy procedures became apparent. We adapted the existing ExoDx Prostate (EPI) office liquid biomarker kit into an At Home Collection Kit physician/ patient shared decisions for prostate biopsy. METHOD(S): A 2-stage program for an At Home Collection Testing Kit program for the ExoDx Test was initiated in April 2020 at the onset of the COVID-19 pandemic. The Phase 1 Pilot study (100 patients, 6 sites) was completed in June 2020. Based on the findings in the pilot, the program was streamlined based on feedback from physicians, patients, and office mangers before making it available in Phase 2 to all urologists in the US. The utilization of the At Home Collection Kits have been measured. RESULT(S): Extensive feedback from the pilot program led to improvements and streamlining before the Phase 2 rollout. As of October 31st, 2022, >30% of all the ExoDx Prostate Tests are At Home Collection Kits. EPI Score distributions are identical (mean 28.4 and 29.7), (median 23.0 and 24.7) in home or clinic sample collection respectively (Figure 1). CONCLUSION(S): The COVID-19 pandemic accelerated major shifts to telehealth and increased use of At Home Testing. The ExoDx Prostate (EPI) At Home Collection Kit was successfully developed and employed to help men (>50 years old) with elevated PSAs (2-10 ng/ml) considering initial or repeat diagnostic biopsy but with pandemic-related fears of visiting offices/hospitals or wanting to avoid long distance travel from rural areas. As COVID becomes manageable and clinical practices have opened, some pandemicadopted approaches remain relevant: the ExoDxTM Prostate, (EPI) At Home Collection Kit is one such approach.

USE OF Ag-RDTs TO REDUCE SARS-CoV-2 INFECTIONS AT RELIGIOUS GATHERINGS IN LICS & MICS

Background: Throughout the COVID-19 pandemic, it was evident that many SARS-CoV-2 infections occurred at mass gathering events. In many LMICs and LICs, places of worship serve as a venue for mass gatherings, and therefore a potential source of large-scale transmission events. Mass gatherings at places of worship also serve as an opportunity to distribute Ag-RDTs to a significant proportion of the community at regular intervals, disrupting transmission within the event and potentially impacting community spread of SARS-CoV-2. Method(s): We used an agent-based community assessment model, Propelling Action for Testing and Treatment, to estimate how various strategies of asymptomatic Ag-RDT self-testing of a fixed percentage of persons attending large religious gatherings (10%, 20%, 40%, 100%), in addition to the general underlying level of ongoing symptomatic testing in the population, would impact community transmission of SARS-CoV-2 in 3 contexts (Brazil, Georgia, Zambia). These testing strategies were analyzed with bi-weekly and weekly asymptomatic self-testing in a population with varying levels of vaccine efficacy (low/high), vaccine coverage (10%, 50%, 80%), and reproductive numbers (0.9, 1.2, 1.5, and 2.0) to simulate varying stages of the COVID-19 pandemic. We then performed an economical evaluation of the results from the model to understand the impact and cost-effectiveness of each self-testing strategy at places of worship. Result(s): In each of the epidemic conditions modeled, testing of symptomatic persons at weekly and biweekly frequencies can avert 2%-16% of Brazilian community infections and 31%-45% of infections occurring in places of worship in Brazil. The same is true in Georgia (1%-6% of total infections and 28%-45% place of worship-related infections) and Zambia (2%-21% of total infections and 29%-45% of place of worship related infections) despite differences in the proportion of populations regularly attending places of worship in the 3 countries. Asymptomatic self-testing in 100% of places of worship in a country result in the greatest percent of infections averted and consistently lands on the cost-effectiveness frontier yet requires a budget 520- 1550x greater than that of symptomatic testing alone. Conclusion(s): Testing of symptomatic persons attending regular religious gatherings have a significant impact on the spread of SARS-CoV-2 in places of worship and can significantly reduce community spread in contexts where population level attendance at religious gatherings is high. Cost-effectiveness analysis from Brazil, Georgia and Zambia modelling results with infections averted within places of worship and total community infections averted assuming a total cost per self-test of $2.50 USD.

HOME VERSUS FACILITY SARS-CoV-2 TESTING AMONG OLDER ADULTS IN NEW YORK CITY

Background: While nationwide SARS-CoV-2 testing in the United States shifted from facility- to home-based in 2021, less is known about testing behavior of older adults who live at home. We analyze characteristics of older adults who reported facility-based testing with those who tested only at home or at both locations. Method(s): Adults 70 years and older living at home with a landline in New York City were selected using random digit dialing and completed a COVID-19 survey from February 2022 - March 2022. We conducted descriptive statistics using survey weights and bi-variable and multivariable analyses. Result(s): Overall, 237 of a total of 294 (81%) participants had tested for SARS-CoV-2 in the prior year. Among those who tested, 81% had tested only at a facility, 4% only tested at home, and 15% tested at both locations (home and facility). White participants more often reported testing at both locations (27%) compared to Black (7%), Latinx (7%) or participants of another race (11%;p-value: 0.004). Those with college education or higher were less likely to rely solely on facilities for testing (75%) compared to those with less education (91%;p-value: 0.02) and 38% of those who reported currently working had tested both locations compared to only 12% of those who were not working (pvalue: 0.002). There were no differences in testing by age, sexual orientation, or self-reported mobility. A multivariable logistic regression model that compared those who only tested at a facility with those who tested at both locations or only at home found that when adjusting for working status, age group and education, compared to White participants, Black participants had a third (0.33) the odds of white participants of testing at home or at both locations (p-value: 0.026). Conclusion(s): In this sample of urban older adults, using a facility for SARS-CoV-2 testing was more frequently reported than testing at home, indicating the need to retain facility-based testing for this population. However, White participants, more educated participants and those who were working more frequently reported home-based testing compared to other groups suggesting that social constraints may limit access to home testing among the latter group of older adults.

Ultrasonic personal spirometer appears accurate and feasible for remote monitoring

Introduction/Aim: Home spirometry may improve respiratory disease monitoring and management and mitigate the decline in testing exacerbated by COVID-19. Smartphone-connected spirometers could allow patients to conduct spirometry independently without the need to travel to lung function clinics. This study assessed the accuracy of a personal spirometer and the feasibility of unsupervised home spirometry. Method(s): Subjects (19-88 years) with (n = 44) and without (n = 20) respiratory disease, were recruited and supervised to perform spirometry on a standard desktop spirometer (MGC Diagnostics) and a personal ultrasonic spirometer (SpiroHome) in the clinical laboratory. Unsupervised testing was subsequently conducted using the SpiroHome at the subjects' home (2 tests/week for 3 weeks). Subjects returned to the clinic to conduct an exit survey which assessed their willingness to adopt a personal spirometer into their long-term care plan. Comparisons between desktop and personal spirometry, as well as supervised and unsupervised spirometry, were compared by Bland-Altman analysis (%Bias +/- CI) and Pearson's correlation. Result(s): The proportion of tests meeting American Thoracic Society/European Respiratory Society criteria (80%) remained constant across clinic and home spirometry sessions for subjects who completed 3 weeks of home testing (p = 0.73, Fisher's exact test, n = 61). Supervised spirometry on the SpiroHome (n = 56) reliably measured FEV 1 (-3.12+/-27.01%;r=0.98, p < 0.0001) and FVC (-0.38+/-22.91%;r=0.99, p < 0.0001) producing a small underestimation compared to desktop spirometry. Unsupervised home spirometry (when performed <24 hrs from the clinic appointment) on the SpiroHome (n = 51) produced a small underestimation of FEV 1 (-2.41+/-35.57%;r=0.96, p < 0.0001) and a slight overestimation of FVC (0.08+/-24.70%;r=0.98, p < 0.0001) compared with supervised manoeuvres in the clinical laboratory. Conclusion(s): Findings indicate that lung function assessed by SpiroHome compares well with in-clinic standard desktop spirometry across a range of diseases and severities in both the clinic and home settings. A larger cohort of subjects are being recruited to confirm the accuracy and the overall utility of personal spirometry.

Impact and Cost-Effectiveness of Covid-19 Rapid Self-Testing Strategies in Schools

Background: Despite widespread vaccination and increasing population immunity from previous infections, community transmission of COVID-19 continues, and testing may continue to be an important component of our response particularly with the proliferation of new variants of concern. Strategic deployment of SARS-CoV-2 antigen-detection rapid diagnostic (AgRDT) self-tests to settings with increased transmission potential can reduce the viral burden within the specific settings, such as in K-12 schools, and may have spillover benefits for broader community transmission. Method(s): Using a previously developed agent-based simulation model, parameterized to three distinct country archetypes (Brazil, Georgia, Zambia), we analyzed 11 different self-testing strategies within the school-going population at three testing frequencies under 24 different epidemic conditions (Rt, vaccination coverage/effectiveness), comprising a total of 696 scenarios per country. Strategies included symptomatic testing, and in addition, asymptomatic testing at 5, 20, 40 or 100% of schools, or asymptomatic contact testing. These were all targeted to either only teachers or teachers and students. Then, with the cost to offer a COVID-19 self-test in schools at USD 2.50, we performed an economic analysis with all scenarios to identify the most costeffective strategies by country. Result(s): Routine asymptomatic testing of teachers and students at 100% of schools reduced the greatest number of infections across contexts, but at the greatest cost. However, with respect to both the reduction in infections and total cost, symptomatic testing of all teachers and students appears to be the most efficient strategy. Symptomatic testing can prevent up to 69.3%, 64.5%, and 75.5% of school infections in Brazil, Georgia, and Zambia, across all epidemic conditions. Additionally, it can prevent up to 77,200, 80,900, 107,800 symptomatic days per 100,000 teachers and students in each country, respectively, over the course of a 90-day epidemic wave. The incremental cost-effectiveness ratios for strategies that consistently appeared on the costeffectiveness frontier across countries and epidemic conditions are shown in Figure 1 for an Rt of 1.2. Conclusion(s): If financial resources are limited, symptomatic testing of teachers and students has the potential to be cost-effective while reducing a substantial number of infections and the amount of time lost from the classroom, making it a feasible strategy for implementation in a variety of settings.

Is self-testing the next paradigm for diagnostics?

The study estimates the usability and attitude assessment of users for India's first approved rapid antigen self-test kit;the CoviSelf™. India approved its first AI-powered self-test for Covid-19 in April 2021 a few weeks after the first approval in the US. We present here a study on usability and attitude assessment of users of India's first approved rapid antigen self-test kit;the CoviSelf™. The study evaluates participants' understanding of and performance of test procedure and interprets the results. Analysis revealed that more than 90% study participants followed steps correctly as illustrated in the user's manual. Age group and gender-based analysis showed comparable scores for usability of the test kit suggesting users of different age groups has same ease in using the test kit. What we learnt from this study could be start of self-test revolution, where rapid tests could expand the access of diagnostics for hundreds of diseases including HIV, HPV, and dengue to millions of people who could not get access to diagnostics because we lacked manpower or facility to conduct tests. Self-testing could break the barriers for diagnostics that Internet did for information.

An extraction-free one-step CRISPR-assisted detection platform and a potential Streptococcus pneumoniae at-home self-testing kit.

A rapid, accurate, easy-to-use nucleic acid detection technology is essential for disease diagnosis and control. Herein, we improved CRISPR-top (cluster regularly interspaced short palindromic repeats-mediated testing in one-pot) to develop Extraction-free one-step CRISPR-assistant detection (ExCad), a simple, rapid, accurate gene detection tool for unextracted colonies and samples. We established a pretreatment protocol to rapidly liquify sputum samples and release nucleic acids within 10 min. The ExCad results can be visualised by a real-time fluorescence reader or the naked eye under blue light. We developed an ExCad-Sp assay to detect Streptococcus pneumoniae from unextracted strains and specimens, and optimised the assay conditions. Assay feasibility was evaluated using sputum samples from 32 patients, and it achieved 92.9 % (13/14) sensitivity, 100 % (18/18) specificity, 100 % (13/13) positive predictive value, and 94.7 % (18/19) negative predictive value compared with bacteria culture. The ExCad-Sp assay has potential for developing an at-home self-testing kit for S. pneumoniae.

Web-based pediatric visual acuity testing at home

Introduction: Pediatric eye care access, particularly in rural areas, has been an ongoing concern. The COVID-19 pandemic has led to a growing appreciation and acceptance of a role for telemedicine in pediatric eye care. However, many at-home visual acuity (VA) charts and apps have poor test design or inaccurate optotype sizes, and may passively provide misinformation for clinical decision making.1-3 We evaluated the new M&S EyeSimplify At-Home Visual Acuity Tests, which include web-based versions of the ATS-HOTV and E-ETDRS tests commonly used in clinical trials. Method(s): Children with and without VA deficits were enrolled. In-office VA was tested with the M&S Smart System ATS-HOTV (ages 3-6;N = 34;68 eyes) or E-ETDRS (ages 7-12;N = 31;62 eyes) protocol. The child was registered on the EyeSimplify web-based portal and the parent was emailed a link to the at-home VA test. The portal notified us when at-home testing was completed and provided us on-line access to VA results. Equivalence of the two test settings was evaluated by mean difference and 95% limits of agreement (LOA) using Bland-Altmann analysis. Result(s): The mean difference between in-office and at-home was small for both ATS-HOTV (0.01 + 0.08 logMAR) and E-ETDRS 0.04 + 0.08 logMAR;95% LOA = -0.15 to 0.17 and -0.11 to 0.19, respectively, comparable to test-retest agreement in an office setting. Conclusion/Relevance: The M&S EyeSimplify At-Home Visual Acuity Tests provided VA equivalent to in-office testing. If the burden of travel is significant, at-home testing may provide the information needed to continue care via telemedicine consultation when it might otherwise be discontinued or delayed.Copyright © 2022

APP test system: a case study of calculus

COVID-19 has had a broad impact on society, and a profound impact on education, thus, distance online courses are seen as a way to continue schooling during the pandemic. This study employed Android Studio to develop an APP calculus learning test system which can be used for self-review exercises and allows students to make good use of mobile apps to conduct post-learning and self-testing of calculus at home, and immediately determine their learning results. In addition, through back-end access, teachers can view students' learning scores and the number of wrong and correct questions, and thus, know the effect of individual students' self-review. During the COVID-19 pandemic, as teachers and students cannot interact in class at school, teachers can use the APP calculus learning test system to provide distance remedial teaching to students who fall behind during the course.