Daily Rapid Antigen Exit Testing to Tailor University COVID-19 Isolation Policy.

We evaluated daily rapid antigen test (RAT) data from 323 COVID-19-positive university students in Connecticut, USA, during an Omicron-dominant period. Day 5 positivity was 47% for twice-weekly screeners and 26%-28% for less-frequent screeners, approximately halving each subsequent day. Testing negative >10 days before diagnosis (event time ratio (ETR) 0.85 [95% CI 0.75-0.96]) and prior infection >90 days (ETR 0.50 [95% CI 0.33-0.76]) were significantly associated with shorter RAT positivity duration. Symptoms before or at diagnosis (ETR 1.13 [95% CI 1.02-1.25]) and receipt of 3 vaccine doses (ETR 1.20 [95% CI 1.04-1.39]) were significantly associated with prolonged positivity. Exit RATs enabled 53%-74% of students to leave isolation early when they began isolation at the time of the first positive test, but 15%-22% remained positive beyond the recommended isolation period. Factors associated with RAT positivity duration should be further explored to determine relationships with infection duration.

Who's on third? Regulation of third-party genetic interpretation services.

In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services' Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

Valuable Genomes: Taxonomy and Archetypes of Business Models in Direct-to-Consumer Genetic Testing.

BACKGROUND: Recent progress in genome data collection and analysis technologies has led to a surge of direct-to-consumer (DTC) genetic testing services. Owing to the clinical value and sensitivity of genomic data, as well as uncertainty and hearsay surrounding business practices of DTC genetic testing service providers, DTC genetic testing has faced significant criticism by researchers and practitioners. Research in this area has centered on ethical and legal implications of providing genetic tests directly to consumers, but we still lack a more profound understanding of how businesses in the DTC genetic testing markets work and provide value to different stakeholders. OBJECTIVE: The aim of this study was to address the lack of knowledge concerning business models of DTC genetic testing services by systematically identifying the salient properties of various DTC genetic testing service business models as well as discerning dominant business models in the market. METHODS: We employed a 3-phased research approach. In phase 1, we set up a database of 277 DTC genetic testing services. In phase 2, we drew on these data as well as conceptual models of DTC genetic testing services and iteratively developed a taxonomy of DTC genetic testing service business models. In phase 3, we used a 2-stage clustering method to cluster the 277 services that we identified during phase 1 and derived 6 dominant archetypes of DTC genetic testing service business models. RESULTS: The contributions of this research are 2-fold. First, we provided a first of its kind, systematically developed taxonomy of DTC genetic testing service business models consisting of 15 dimensions in 4 categories. Each dimension comprises 2 to 5 characteristics and captures relevant aspects of DTC genetic testing service business models. Second, we derived 6 archetypes of DTC genetic testing service business models named as follows: (1) low-cost DTC genomics for enthusiasts, (2) high-privacy DTC genomics for enthusiasts, (3) specific information tests, (4) simple health tests, (5) basic low-value DTC genomics, and (6) comprehensive tests and low data processing. CONCLUSIONS: Our analysis paints a much more complex business landscape in the DTC genetic testing market than previously anticipated. This calls for further research on business models and their effects that underlie DTC genetic testing services and invites specific regulatory interventions to protect consumers and level the playing field.

Missed opportunities for earlier diagnosis of human immunodeficiency virus infection among adults presenting to Auckland District Health Board hospital services.

BACKGROUND: Earlier diagnosis of human immunodeficiency virus (HIV) infection improves health outcomes and reduces transmission. In New Zealand, half of new HIV diagnoses between 2005 and 2010 had a cluster of differentiation 4 count below 350 cells/mm3 . HIV screening is already offered in antenatal settings in New Zealand, but not universally in hospital settings. AIMS: To assess the impact of missed opportunities to diagnose HIV infection in adults presenting to hospital services at Auckland District Health Board (ADHB). METHODS: Retrospective cohort analysis of all new diagnoses of HIV infection in adults aged 15-64 years residing within the ADHB catchment area over a 7-year period. Those who had contact with hospital services prior to diagnosis, but within their estimated window of undiagnosed infection, were compared with those without such contact. RESULTS: Of 201 newly diagnosed patients, 68 had prior hospital contact within their estimated window of HIV infection, 68% of whom were men who have sex with men. These patients could potentially have been diagnosed earlier by a median of 12 months (range 1-84). Missed opportunity visits occurred across a wide range of hospital services, and included visits for conditions that indicated risk for, or actual, HIV infection. Thirteen patients had HIV-associated illnesses at the time of diagnosis that could have been prevented if diagnosed earlier. CONCLUSION: Our current risk-based HIV screening strategy commonly results in late diagnosis, negative health impacts and possibly avoidable transmissions. Further study is warranted to model the feasibility and potential impact of universal HIV screening at ADHB.

Point-of-care testing for hepatitis C virus infection at an Italian dental clinic: portrait of the pilot study population.

The dental clinic is an appropriate place to promote the prevention of hepatitis C virus (HCV) infection and fast access for care of HCV-positive subjects with new-generation anti-HCV drugs. This study aimed to determine the socio-demographic profile of subjects screened for HCV virus in a dental clinic to acquire useful information for future campaigns of prevention. An easy, free-of-charge, screen salivary test was offered to patients referred to the dental clinic of San Raffaele Scientific Research Hospital in Milan, Italy for dental procedures. These patients were also asked to complete an anonymous questionnaire on demographics and risk behaviours. A total of 1388 of 2097 (66.19%) questionnaires were evaluable. The demographics of the population responding to this initiative was primarily Italians citizen (96.47%), homogeneous gender distribution (55.55%), age over 50 (609 subjects; 43.88%), with high-level education and stable professional positions. 905 subjects (65.20%) were never tested for HCV before. The test showed positive reactivity in 22 cases (1.05%); of these, 21 subjects were known to be HCV-positive, and the test confirmed their status. One subject was newly diagnosed as HCV-positive. The percentage of subjects who were never tested for HCV infection appears too high (905 subjects, i.e., 65.20%), especially among subjects with high level of education and professions, and among adults over 40 or young people (18-25). The easy screening test in dental clinic can help raise awareness, promote early diagnosis and prevention, and provide a fast link to care for HCV infection.

Impact of community pharmacist-provided preventive services on clinical, utilization, and economic outcomes: An umbrella review.

Preventable diseases and late diagnosis of disease impose great clinical and economic burden for health care systems, especially in the current juncture of rising medical expenditures. Under these circumstances, community pharmacies have been identified as accessible venues to receive preventive services. This umbrella review aims to examine existing evidence on the impact of community pharmacist-provided preventive services on clinical, utilization, and economic outcomes in the United States (US). We included systematic reviews, narrative reviews and meta-analyses published in English between January 2007 and October 2017. Of 2742 references identified by our search strategy, a total of 13 research syntheses met our inclusion criteria. Included reviews showed that community pharmacists are effective at increasing immunization rates, supporting smoking cessation, managing hormonal contraception therapies, and identifying patients at high risk for certain diseases. Moreover, evidence suggests that community pharmacies are especially well-positioned for the provision of preventive services due to their convenient location and extended hours of operation. There is general agreement on the positive impact of community pharmacists in increasing access to preventive health, particularly among patients who otherwise would not be reached by other healthcare providers. The provision of preventive services at US community pharmacies is feasible and effective, and has potential for improving patient outcomes and health system efficiency. However, high-quality evidence is still lacking. As the healthcare landscape shifts towards a value-based framework, it will be important to conduct robust studies that further evaluate the impact of community pharmacist-provided preventive services on utilization and economic outcomes.

Information Provision Regarding Health-Related Direct-to-Consumer Genetic Testing for Dutch Consumers: An in-Depth Content Analysis of Sellers' Websites.

Background: Previous studies have suggested that information offered by sellers of health-related direct-to-consumer genetic tests (DTC-GTs) is often incomplete, unbalanced, or too difficult to understand. The extent to which this is the case for sellers accessible to Dutch consumers has not previously been studied. Methods and Goals: The present study aimed to assess the completeness, balance, readability, and findability of informational content on a selection of websites from several health-related DTC-GT sellers accessible to Dutch consumers. An in-depth content analysis was performed based on a recently published checklist outlining key items for policy guidance regarding DTC-GT services. Results: The information provided by sellers did not equally cover all aspects relevant to health-related DTC-GT service provision. The provided information was slightly unbalanced, with benefits of health-related DTC-GT usage being overemphasized compared to its risks and limitations. The readability of the provided information was low, on average requiring college education for proper understanding. A findability analysis showed that information concerning all themes is overall relatively evenly distributed across analyzed sellers' websites. Conclusions: Information provision by assessed health-related DTC-GT sellers is suboptimal regarding completeness, balance, and readability. To better empower potential consumers to make an informed decision regarding health-related DTC-GT usage, we advocate industry-wide enhancement of information provision.

Sperm donor attitudes and experiences with direct-to-consumer genetic testing.

Objective: To identify factors influencing sperm donor willingness to participate in direct-to-consumer genetic testing, comfort with sharing genetically identifiable data in commercial genetic testing databases, and likelihood to donate sperm again. Design: Cross-sectional online anonymous survey. Setting: Multicenter, 2 large American sperm banks from July 1, 2020 to July10, 2021. Patients: Sperm donors from 1980 to 2020. Interventions: None. Main outcome measures: Associations between donor demographic characteristics, donation history, and attitudes toward direct-to-consumer genetic testing. Results: A total of 396 donors completed the survey. Most donations (61.5%) occurred from 2010 to 2020, and 34.3% were nonidentified donations. Nonidentified donors were less comfortable with their genetic data being shared than open-identity donors (25.4% vs. 43.8%) and were less likely than open-identity donors to donate sperm again (43.3% vs. 72.1%). Donors who donated after the inception of direct-to-consumer genetic testing in 2007 were less likely to participate in commercial genetic testing than those who donated before 2007 (25.8% vs. 37.1%). Most donors (87.4%) have disclosed their donation(s) to current partners, but fewer have disclosed them to their families (56.6%) or children (30.5%). Of the donors who had been contacted by donor-conceived persons, 79.5% were identified via direct-to-consumer genetic testing. Overall, 61.1% of donors would donate again regardless of direct-to-consumer genetic testing. Conclusions: Direct-to-consumer genetic testing is playing a dynamic role in sperm donor identification, but donors seem willing to donate again. Implication counseling regarding future linkage and contact from donor-conceived persons needs to be standardized for potential donors before donation.

A Web-Based, Mail-Order Sexually Transmitted Infection Testing Program: Qualitative Analysis of User Feedback.

BACKGROUND: The incidence of sexually transmitted infections (STIs) is increasing in the United States. The COVID-19 pandemic resulted in significant reductions in access to health care services, including STI testing and treatment, leading to underreporting of STI cases and a need for alternatives to clinic-based testing. Moreover, concerns around confidentiality, accessibility, and stigma continue to limit access to clinic-based STI testing, particularly for high-priority populations. IWantTheKit (IWTK) is a web-based platform that mails free, confidential, self-administered sample collection kits for testing for gonorrhea, chlamydia (both genital and extragenital sites), and vaginal trichomonas. Individuals visiting the IWTK website may select genital, pharyngeal, and rectal samples for chlamydia and gonorrhea testing. Vaginal samples are tested for trichomoniasis. Self-collected samples are processed in a College of American Pathologists-accredited laboratory, and results are posted to an individual's secure digital account. OBJECTIVE: This study aimed to (1) describe users' experience with the IWTK service through analysis of routine data and (2) optimize retention among current users and expand reach among high-priority populations by responding to user needs through programmatic and functional changes to the IWTK service. METHODS: Free-text entries were submitted by IWTK users via a confidential "Contact Us" page on the IWTK website from May 17, 2021, to January 31, 2022. All entries were deidentified prior to analysis. Two independent analysts coded these entries using a predefined codebook developed inductively for thematic analysis. RESULTS: A total of 254 free-text entries were analyzed after removing duplicates and nonsensical entries. Themes emerged regarding the functionality of the website and personal experiences using IWTK's services. Users' submissions included requests related to order status, address changes, replacement of old kits, clinical information (eg, treatment options and symptom reports), and reported risk behaviors. CONCLUSIONS: This analysis demonstrates how routine data can be used to propose potential programmatic improvements. IWTK implemented innovations on the website based on the study results to improve users' experience, including a tracking system for orders, address verification for each order, a physical drop box, additional textual information, direct linkage to care navigation, and printable results. Web-based, mail-order STI testing programs can leverage user feedback to optimize implementation and retention among current users and potentially expand reach among high-priority populations. This analysis is supported by other data that demonstrate how comprehensive support and follow-up care for individuals testing positive are critical components of any self-testing service. Additional formal assessments of the IWTK user experience and efforts to optimize posttesting linkage to care may be needed.

Considerations for developing regulations for direct-to-consumer genetic testing: a scoping review using the 3-I framework.

Direct-to-consumer (DTC) genetic testing exists largely outside of any regulatory schemes, and studies providing a comprehensive overview of the ethical, social, legal, and technological considerations for regulating these types of technologies are lacking. This paper uses the 3-I framework for policy analysis to analyze the ideas, interests, and institutions relevant to policy development for DTC genetic testing in North America and internationally. A scoping review was conducted. Citation databases were searched for papers addressing the ethical, social, legal, and technological implications of DTC genetic testing; stakeholder perspectives on and experiences with DTC genetic testing; or the effect of such testing on the healthcare system. Ninety-nine publications, organizational reports, governmental documents, or pieces of legislation were included. The ideas included are autonomy, informed decision making, privacy, and clinical validity and utility. The interests discussed are those of the public and healthcare providers. The institutions included are regulatory organizations such as the Food and Drug Administration in the United States, laws governing the implementation or delivery of genetic testing in general, and legislation created to protect against genetic discrimination. This analysis clarifies the ethical, social, legal, and technological issues of DTC genetic testing regulation. This information can be used by policy makers to develop or strengthen regulations for DTC genetic testing such as requiring an assessment of the clinical validity of tests before they become publicly available, controlling how tests are marketed, and stipulating requirements for healthcare provider involvement and informed consent.

Acceptability of dual HIV/syphilis rapid test in community- and home-based testing strategy among transgender women in Buenos Aires, Argentina.

BACKGROUND: Little is known of acceptability and feasibility of dual HIV and syphilis rapid tests in community- and home-based provider-initiated strategies among transgender women (TGW), in Latin America. Objectives were (1) to assess the acceptability of this strategy and, (2) to determine the percentage of positive results of HIV and syphilis, analyze the correlates of HIV or syphilis positive results, and measure the rates of effective referral and treatment completion among TGW. METHODS: A multidisciplinary team tested 89 TGW in Buenos Aires. An acceptability survey was administered after the HIV/syphilis Duo test was used. All confirmed cases were referred for treatment initiation. RESULTS: We found high levels of acceptability (98.8%) of this strategy among TGW. However, only 60.7% preferred simultaneous HIV and syphilis diagnosis test. Moreover, we found 9% of positive results of HIV, 51.7% of syphilis, and 3.4% of positive results for both infections. Only not being tested before was associated with an HIV positive result, and only low level of education was associated with a positive syphilis result. Among 8 TGW who tested positive for HIV, 37.5% (n = 3) started antiretroviral therapy. Of 46 who tested positive for syphilis, only 73.9% (n = 34) were effectively referred and from 23 who started treatment, only 39.1% completed it. CONCLUSIONS: Community- and home-based dual HIV and syphilis rapid test is a feasible and highly acceptable approach for this hard-to-reach population. Implementing similar strategies could improve screening uptake and accessibility. However, these results highlight the need to improve strategies for treatment uptake, in order to reduce morbidity and risk of onward transmission.

Direct-to-Consumer Genetic Testing in Korea: Current Status and Significance in Clinical Nutrition.

Direct-to-consumer genetic testing (DTC-GT) provides a means for consumers to gain insights into their genetic background and how it relates to their health without the involvement of medical institutions. In Korea, DTC-GT was introduced in 2016 in accordance with the legislation on Paragraph (3) 2 of Article 50 of the Bioethics and Safety Act. Only 12 genetic test items involving 46 genes were approved at first, but the approved items were expanded to 70 in November 2020. However, the genetic test items of DTC-GT services in Korea are still restricted to the wellness area, and access to disease risk related information is only permitted to medical institutions. Further, studies revealing the relationship between genotype differences and responses to nutrients, food components, or nutritional status are increasing, and this association appears to be robust for some genes. This strong association between genetic variations and nutrition suggests that DTC-GT can be used as an important tool by clinical nutritionists to gain insights into an individual's genetic susceptibilities and provide guidance on nutritional counseling and meal planning based on the patient's genetic information. This review summarized the history and current status of DTC-GT and investigated the relationship between genetic variations with associated phenotypic traits to clarify further the importance of DTC-GT in the field of clinical nutrition.

A Qualitative Study to Develop a Privacy and Nondiscrimination Best Practice Framework for Personalized Wellness Programs.

Employers in the United States (US) increasingly offer personalized wellness products as a workplace benefit. In doing so, those employers must be cognizant of not only US law but also European Union (EU) law to the extent that the EU law applies to European immigrants or guest workers in the US. To the extent that wellness programs are implemented in either public health or employment contexts within the US and/or EU, sponsors of these programs can partner with direct-to-consumer (DTC) genetic testing companies and other digital health companies to generate, collect, and process sensitive health information that are loosely or partially regulated from a privacy and nondiscrimination standpoint. Balancing claims about the benefits of wellness programs are concerns about employee health privacy and discrimination and the current unregulated nature of consumer health data. We qualitatively explored the concerns and opinions of public and legislative stakeholders in the US to determine key themes and develop privacy and nondiscrimination best practices. Key themes emerged as promoting a culture of trust and wellness. Best practices within these themes were: (1) have transparent and prominent data standards and practices, (2) uphold employee privacy and nondiscrimination standards, (3) remove penalties associated with biometric outcomes and nondisclosure of sensitive health information, (4) reward healthy behavior regardless of biometric outcomes, and (5) make program benefits accessible regardless of personal status. Employers, DTC genetic testing companies, policymakers, and stakeholders broadly should consider these themes and best practices in the current absence of broad regulations on nondiscriminatory workplace wellness programs.

Clinical evaluation and diagnostic yield following evaluation of abnormal pulse detected using Apple Watch.

OBJECTIVE: The study sought to characterize the evaluation of patients who present following detection of an abnormal pulse using Apple Watch. MATERIALS AND METHODS: We conducted a retrospective review of patients evaluated for abnormal pulse detected using Apple Watch over a 4-month period. RESULTS: Among 264 included patients, clinical documentation for 41 (15.5%) explicitly noted an abnormal pulse alert. Preexisting atrial fibrillation was noted in 58 (22.0%). Most commonly performed testing included 12-lead echocardiography (n = 158; 59.8%), Holter monitor (n = 77; 29.2%), and chest x-ray (n = 64; 24.2%). A clinically actionable cardiovascular diagnosis of interest was established in only 30 (11.4%) patients, including 6 of 41 (15%) patients who received an explicit alert. DISCUSSION: False positive screening results may lead to overutilization of healthcare resources. CONCLUSIONS: The Food and Drug Administration and Apple should consider the unintended consequences of widespread screening for asymptomatic ("silent") atrial fibrillation and use of the Apple Watch abnormal pulse detection functionality by populations in whom the device has not been adequately studied.

Avance genético y políticas de anonimato / Genetic advance and anonymity policies / Avanço genético e políticas de anonimato

Resumen En los últimos años se ha incrementado en Argentina la cantidad de tratamientos de reproducción asistida con donación de gametos (óvulos y/o espermatozoides). La filiación por técnicas de reproducción asistida heterólogas interroga la tradicional "herencia de sangre" objeto de estudio privilegiado de las ciencias sociales. En las últimas décadas, el paradigma sobre el anonimato de los donantes ha cambiado en muchos países. A su vez, se ha sugerido que los rápidos y generalizados avances en las pruebas genéticas podrían modificar las políticas de anonimato. ¿Cuáles son las consecuencias de fundamentar la revelación de la información genética/identificatoria sobre la base del mayor acceso que posibilitan los test genéticos? La presente reflexión parte de dos vertientes: la pública - que analiza las paradojas que encierra el articulado del nuevo Código Civil y Comercial (2015) - y la íntima, que ubica las coordenadas sobre las que se inscribe la transmisión singular de los orígenes.

Abstract In recent years, the number of assisted reproduction treatments with the donation of gametes (ovules and/or sperm) has increased in Argentina. The filiation by heterologous assisted reproduction techniques interrogates the traditional "blood inheritance" object of privileged study of the social sciences. In recent decades, the donor anonymity paradigm has changed in many countries. In turn, it has been suggested that rapid and widespread advances in genetic testing could modify anonymity policies. What are the consequences of substantiating the disclosure of genetic/identifying information based on the greater access that genetic tests allow? This reflection is based on two aspects: the public aspect - which analyzes the paradoxes contained in the articles of the new Civil and Commercial Code (2015) - and the intimate one, which locates the coordinates on which the singular transmission of the origins is inscribed.

Resumo Nos últimos anos, o número de tratamentos de reprodução assistida com doação de gametas (óvulos e/ou espermatozoides) aumentou na Argentina. A filiação por técnicas de reprodução assistida heteróloga interroga a tradicional "herança sanguínea", objeto de estudo privilegiado das ciências sociais. Nas últimas décadas, o paradigma do anonimato dos doadores mudou em muitos países. Por sua vez, sugeriu-se que avanços rápidos e generalizados em testes genéticos poderiam modificar as políticas de anonimato. Quais são as consequências de fundamentar a revelação das informações genéticas/de identificação com base no maior acesso que o teste genético torna possível? Esta reflexão parte de duas vertentes: a pública, que analisa os paradoxos dos artigos do novo Código Civil e Comercial (2015); e a íntima, que determina as coordenadas sobre as quais se inscrevem a transmissão singular das origens.