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.

Sleep testing during the pandemic.

BACKGROUND: The COVID-19 pandemic disrupted the U.S. healthcare system, reducing the capacity available for unrelated conditions, such as sleep disordered breathing, and increasing concerns about the safety of in-lab testing. This study characterizes how the pandemic impacted the assessment of sleep disordered breathing and use of associated services. METHODS: Sleep testing claims occurring between January 2019 and June 2021 were extracted from the database of a national healthcare organization. Utilization was trended. Logistic regressions were run to assess the association between quarter of initial testing, whether testing was followed by treatment, and whether testing was followed by a clinical visit with a diagnosis related to sleep apnea, after controlling for patient-related factors. A Cox proportional hazards model assessed factors influencing time to treatment. Finally, a logistic regression assessed factors influencing the finality of home-based testing. RESULTS: In Q2 2021, home-based testing utilization was 134% of its initial level, while in-lab and split night testing were both at 61% of initial levels. Patients receiving initial home-based testing did not significantly differ in their likelihood of treatment, but were significantly less likely to have a clinical visit for sleep apnea (P < 0.01). Patients initially tested in 2021 were treated significantly more quickly than those initially tested in Q1 2019. Home-based testing occurring in Q4 2019 or later was significantly more likely to be definitive than home-based testing occurring Q1 2019. CONCLUSIONS: Home-based sleep testing increased significantly and durably in 2020, and was associated with faster time to treatment than initial in-lab testing.

A pragmatic randomized trial of home-based testing for COVID-19 in rural Native American and Latino communities: Protocol for the "Protecting our Communities" study.

BACKGROUND: Home-based testing for COVID-19 has potential to reduce existing health care disparities among underserved populations in the United States. However, implementation of home-based tests in these communities may face significant barriers. This study evaluates the acceptability, feasibility, and success of home-based testing and the potential added benefit of active support from trusted community health workers for Native Americans and Hispanic/Latino adults living in rural Montana and Washington states. METHODS/DESIGN: The academic-community research team designed the trial to be responsive to community needs for understanding barriers and supports to home-based COVID-19 testing. The "Protecting Our Community" study is a two-arm pragmatic randomized controlled trial in which a total of 400 participants are randomized to active or passive arms. Participants of both study arms receive a commercially available home collection COVID-19 test kit, which is completed by mailing a self-collected nasal swab to a central laboratory. The primary study outcome is return of the kit to the central lab within 14 days. The cultural, social, behavioral, and economic barriers to home-based COVID-19 testing are also assessed by qualitative research methods. A survey and semi-structured interviews are conducted after the trial to evaluate perceptions and experience of home-based testing. DISCUSSION: Implementing home-based testing in underserved populations, including among Native American and Hispanic/Latino communities, may require additional support to be successful. The Protecting Our Community trial examines the effect of trusted community health workers on use of home-based testing, which may be adaptable for community-driven models of home-based testing in other underserved populations.

Assessing Physical Fitness of Athletes in a Confined Environment during Prolonged Self-Isolation: Potential Usefulness of the Test of Maximal Number of Burpees Performed in 3 Minutes.

Due to a prolonged period of quarantine during the COVID-19 pandemic, it is essential to monitor the physical condition of athletes isolated at home with a fitness tool that measures various aspects of physical fitness, which does not require any special equipment, and can be performed within a small space. This study assessed the reliability and validity of the test of performing the maximal number of burpees in 3 min (or 3-MBT) to monitor strength, power, and aerobic endurance in trained athletes. For Part I (reliability of the 3-MBT), 20 (10 male, 10 female) national athletes from various sports performed the 3-MBT on two separate test sessions. Athletes performed as many burpees as possible within 3 min and the primary performance criteria was the number of burpees completed (where a higher number reflected a better performance). The 3-MBT displayed excellent relative reliability in the athletes, with an intraclass correlation coefficient (ICC) and coefficient of variation (CV %) of >0.92, and <3.0%, respectively. For Part II (validity of the 3-MBT), 40 (20 M, 20 F) athletes performed the 3-MBT, and the countermovement jump (CMJ), isometric mid-thigh pull (IMTP), seated medicine ball throw (SMBT), isometric bench (IBP) and maximal aerobic power (VO2max) tests on separate sessions. When data of male and female athletes were pooled, there were significant correlations between relative 3-MBT and relative CMJ height (r = 0.65, large; p < 0.001), relative IMPT peak force (r = 0.50, large; p < 0.001), relative IBP peak force (r = 0.36, moderate, p = 0.02), and relative VO2max (r = 0.50, large; p < 0.001). In conclusion, the 3-MBT is a reliable and reasonably useful test and is a valid assessment of lower body power and strength, upper body strength and aerobic fitness in trained male and female athletes.