Findings of Feasibility for Serial Testing Using Over-the-Counter SARS-CoV-2 Test with the Assistance of a Digital Smartphone App (Preprint)

BACKGROUND The ongoing pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb SARS-CoV-2 disease transmission, morbidity, and mortality, as well as safely navigate social re-engagement. OBJECTIVE To describe the feasibility and acceptability of serial self-testing for SARS-CoV-2, including need for assistance and reliability of self-interpretation. METHODS A total of 206 adults in the United States with Smartphones were enrolled in this single-arm feasibility study during February and March 2021. All participants were asked to self-test for Covid-19 at home daily using an antigen-detection rapid diagnostic test over a 14-day period and use a smartphone application for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, acceptability of testing and Smartphone application experiences, and reliability of participant versus study team interpretation of test results. RESULTS Among the 206 participants, 52% of study participants were women, the average age was 40.7 years, 34.43% were non-White, and half the sample (56.8%) had received a Bachelor’s degree or higher. Most participants (64.6%) showed high testing adherence. Participants’ interpretations of test results demonstrated high agreement (98.9%) with the study verified results, with a kappa score of 0.29 (p<0.001). Participants reported high satisfaction with self-testing and the smartphone application, with greater than 98% of participants reporting they would recommend the self-test and smartphone application to others. These results were consistent across age, race/ethnicity, and gender groups. CONCLUSIONS Participant’s high adherence to the recommended testing schedule, significant reliability between participant and study staff test interpretation, and acceptability of the smartphone application and self-test indicate that self-tests for SARS-CoV-2 with a smartphone application for assistance and reporting is highly feasible among a diverse population of adults in the United States.

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A Nationwide Survey of COVID-19 Testing in LGBTQ+ Populations in the United States

Public Health Reports ◽

10.1177/00333549211018190 ◽

2021 ◽

pp. 003335492110181

Author(s):

Richard J. Martino ◽

Kristen D. Krause ◽

Marybec Griffin ◽

Caleb LoSchiavo ◽

Camilla Comer-Carruthers ◽

...

Keyword(s):

United States ◽

Gay Men ◽

Antibody Test ◽

Nationwide Survey ◽

The United States ◽

Sociodemographic Characteristics ◽

Full Time ◽

Test Results ◽

Antibody Testing ◽

And Gender

Objectives Lesbian, gay, bisexual, transgender, or queer and questioning (LGBTQ+) people and populations face myriad health disparities that are likely to be evident during the COVID-19 pandemic. The objectives of our study were to describe patterns of COVID-19 testing among LGBTQ+ people and to differentiate rates of COVID-19 testing and test results by sociodemographic characteristics. Methods Participants residing in the United States and US territories (N = 1090) aged ≥18 completed an internet-based survey from May through July 2020 that assessed COVID-19 testing and test results and sociodemographic characteristics, including sexual orientation and gender identity (SOGI). We analyzed data on receipt and results of polymerase chain reaction (PCR) and antibody testing for SARS-CoV-2 and symptoms of COVID-19 in relation to sociodemographic characteristics. Results Of the 1090 participants, 182 (16.7%) received a PCR test; of these, 16 (8.8%) had a positive test result. Of the 124 (11.4%) who received an antibody test, 45 (36.3%) had antibodies. Rates of PCR testing were higher among participants who were non–US-born (25.4%) versus US-born (16.3%) and employed full-time or part-time (18.5%) versus unemployed (10.8%). Antibody testing rates were higher among gay cisgender men (17.2%) versus other SOGI groups, non–US-born (25.4%) versus US-born participants, employed (12.6%) versus unemployed participants, and participants residing in the Northeast (20.0%) versus other regions. Among SOGI groups with sufficient cell sizes (n > 10), positive PCR results were highest among cisgender gay men (16.1%). Conclusions The differential patterns of testing and positivity, particularly among gay men in our sample, confirm the need to create COVID-19 public health messaging and programming that attend to the LGBTQ+ population.

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Barriers and Facilitators to Anticoagulation Patient Self-Testing: National Survey of Anticoagulation Providers in the United States

Value in Health ◽

10.1016/j.jval.2016.03.308 ◽

2016 ◽

Vol 19 (3) ◽

pp. A22 ◽

Cited By ~ 1

Author(s):

N Manzoor ◽

A Goncharenko ◽

EA Nutescu

Keyword(s):

United States ◽

National Survey ◽

The United States ◽

Barriers And Facilitators ◽

Self Testing

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Anticoagulation Clinics and Self-Testing

Fibrinolytic and Antithrombotic Therapy ◽

10.1093/oso/9780195155648.003.0037 ◽

2006 ◽

Author(s):

Richard C. Becker ◽

Frederick A. Spencer

Keyword(s):

United States ◽

Oral Anticoagulation ◽

Vitamin K Antagonists ◽

Anticoagulation Therapy ◽

The United States ◽

Anticoagulation Clinic ◽

Record Keeping ◽

Self Testing ◽

Model Of Management ◽

Patients At Risk

Oral anticoagulation is a time-tested and effective therapy for patients at risk for thromboembolism (Ansell, 1993). Because of the high risk–benefit ratio of oral vitamin K antagonists, physicians are sometimes reluctant to initiate therapy even for well-established indications (Kutner et al., 1991; McCrory et al., 1995). Furthermore, management is recognized as labor intensive. These factors can be minimized and the benefits of treatment maximized by implementation of an expert model of management that can be achieved with a coordinated and focused system of care known as a coordinated anticoagulation clinic (Ansell and Hughes, 1996). Patient self-testing (and management) may also foster more wide-scale and effective treatment of thromboembolic disorders. The concept of a coordinated anticoagulation clinic (ACC) is not new. Programs focusing on the management of oral anticoagulation have existed in the United States since the late 1950s, and several Scandinavian and other European countries are well known for their coordinated programs (Loeliger et al., 1984), some of which oversee the care of all anticoagulated patients in their respective countries. In the United States, ACCs are growing in number and diversity of services, spurred on by increasing evidence of improved clinical outcomes and cost-effectiveness. The basic elements of a coordinated ACC include (1) a manager or team leader (physician, pharmacist), (2) support staff (nurse practitioner, pharmacist, or physician assistant), (3) standardized record keeping and a computerized database, (4) a manual of operation and practice guidelines, and (5) a formal mechanism for communicating with referring physicians and patients. Currently, most oral anticoagulation therapy in the United States is managed by a patient’s personal physician. In essence, the monitoring and dose titration of patients with thromboembolic disease represents a relatively small proportion of the physician’s overall clinical practice. This approach can be characterized as “traditional” or routine medical care. There may be no specialized system or guidelines in place to track patients or ensure their regular follow-up. An ACC uses a focused and coordinated approach to managing anticoagulation (Ansell et al., 1997).

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Longitudinal effects of home-based HIV self-testing on well-being and health empowerment among men who have sex with men (MSM) in the United States

AIDS Care ◽

10.1080/09540121.2019.1622636 ◽

2019 ◽

Vol 32 (2) ◽

pp. 148-154

Author(s):

Tyler B. Wray ◽

Philip A. Chan ◽

Erik M. Simpanen

Keyword(s):

United States ◽

Well Being ◽

The United States ◽

Health Empowerment ◽

Home Based ◽

Self Testing ◽

Longitudinal Effects ◽

Sex With Men

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Positivity Rates of in Vitro Inhalant/ Respiratory and Food Allergy Tests in the Northern Midwestern United States

Ear Nose & Throat Journal ◽

10.1177/014556131809700919 ◽

2018 ◽

Vol 97 (9) ◽

pp. 296-322 ◽

Cited By ~ 1

Author(s):

Michael S. Benninger ◽

Thomas Daly ◽

Kevin Graffmiller

Keyword(s):

United States ◽

Cleveland Clinic ◽

The United States ◽

Test Results ◽

Dust Mites ◽

Upper Midwest ◽

Allergy Test ◽

Wide Variability ◽

Very High

Rates of allergy-test positivity vary by country and by regions within countries. Several studies have looked at allergy test results to determine the most common allergens. Many of these studies have been based on surveys or on studies of small numbers of tests. Positivity rates for allergy tests are poorly defined in the northern midwestern region of the United States. We conducted a study to identify the rates of positive allergy tests for both inhalant/respiratory allergens and food allergens in the upper Midwest. We extracted from our laboratory database the results of all test samples sent for one of eight allergen panels that had been analyzed between Sept. 1, 2014, and Sept. 1, 2015. All testing was performed at The Cleveland Clinic with the Phadia ImmunoCAP system. The percentage of positive tests, the distribution of the most frequently positive tests, and the class of in vitro responses were identified. A total of 148,628 test results for 63 different allergens were identified. Of the 125,190 tests for inhalant/respiratory allergens, the most frequently positive were dog dander (24% of tests), cat dander (23%), dust mites (23% for both Dermatophagoides pteronyssinus and Dermatophagoides farinae), and June grass (21%). Of the 23,438 food tests, the most frequently positive test results were for milk (18%), peanut (17%), wheat (16%), and egg white (15%). Most of the results fell into classes 1 through 3, although there was still a notable number of very high responses (class 5 and 6). These findings suggest that there is wide variability in the positivity of in vitro allergy tests and that the likelihood of a positive result in screening panels can be estimated. Evaluating such rates will help identify the most and least common allergens and will help to cost-effectively refine allergy screening panels.

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Differential effects of intervention timing on COVID-19 spread in the United States

Science Advances ◽

10.1126/sciadv.abd6370 ◽

2020 ◽

Vol 6 (49) ◽

pp. eabd6370 ◽

Cited By ~ 4

Author(s):

Sen Pei ◽

Sasikiran Kandula ◽

Jeffrey Shaman

Keyword(s):

United States ◽

Disease Transmission ◽

Human Mobility ◽

The United States ◽

Control Measures ◽

Basic Reproductive Number ◽

Transmission Model ◽

Reproductive Number ◽

Mobility Data ◽

Nonpharmaceutical Interventions

Assessing the effects of early nonpharmaceutical interventions on coronavirus disease 2019 (COVID-19) spread is crucial for understanding and planning future control measures to combat the pandemic. We use observations of reported infections and deaths, human mobility data, and a metapopulation transmission model to quantify changes in disease transmission rates in U.S. counties from 15 March to 3 May 2020. We find that marked, asynchronous reductions of the basic reproductive number occurred throughout the United States in association with social distancing and other control measures. Counterfactual simulations indicate that, had these same measures been implemented 1 to 2 weeks earlier, substantial cases and deaths could have been averted and that delayed responses to future increased incidence will facilitate a stronger rebound of infections and death. Our findings underscore the importance of early intervention and aggressive control in combatting the COVID-19 pandemic.

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From People to Panthera: Natural SARS-CoV-2 Infection in Tigers and Lions at the Bronx Zoo

mBio ◽

10.1128/mbio.02220-20 ◽

2020 ◽

Vol 11 (5) ◽

Cited By ~ 2

Author(s):

Denise McAloose ◽

Melissa Laverack ◽

Leyi Wang ◽

Mary Lea Killian ◽

Leonardo C. Caserta ◽

...

Keyword(s):

United States ◽

Severe Acute Respiratory Syndrome ◽

Disease Transmission ◽

Emerging Infectious Diseases ◽

Genomic Data ◽

The United States ◽

Cellular Damage ◽

Animal Reservoir ◽

Live Virus ◽

The World

ABSTRACT Despite numerous barriers to transmission, zoonoses are the major cause of emerging infectious diseases in humans. Among these, severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and ebolaviruses have killed thousands; the human immunodeficiency virus (HIV) has killed millions. Zoonoses and human-to-animal cross-species transmission are driven by human actions and have important management, conservation, and public health implications. The current SARS-CoV-2 pandemic, which presumably originated from an animal reservoir, has killed more than half a million people around the world and cases continue to rise. In March 2020, New York City was a global epicenter for SARS-CoV-2 infections. During this time, four tigers and three lions at the Bronx Zoo, NY, developed mild, abnormal respiratory signs. We detected SARS-CoV-2 RNA in respiratory secretions and/or feces from all seven animals, live virus in three, and colocalized viral RNA with cellular damage in one. We produced nine whole SARS-CoV-2 genomes from the animals and keepers and identified different SARS-CoV-2 genotypes in the tigers and lions. Epidemiologic and genomic data indicated human-to-tiger transmission. These were the first confirmed cases of natural SARS-CoV-2 animal infections in the United States and the first in nondomestic species in the world. We highlight disease transmission at a nontraditional interface and provide information that contributes to understanding SARS-CoV-2 transmission across species. IMPORTANCE The human-animal-environment interface of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an important aspect of the coronavirus disease 2019 (COVID-19) pandemic that requires robust One Health-based investigations. Despite this, few reports describe natural infections in animals or directly link them to human infections using genomic data. In the present study, we describe the first cases of natural SARS-CoV-2 infection in tigers and lions in the United States and provide epidemiological and genetic evidence for human-to-animal transmission of the virus. Our data show that tigers and lions were infected with different genotypes of SARS-CoV-2, indicating two independent transmission events to the animals. Importantly, infected animals shed infectious virus in respiratory secretions and feces. A better understanding of the susceptibility of animal species to SARS-CoV-2 may help to elucidate transmission mechanisms and identify potential reservoirs and sources of infection that are important in both animal and human health.

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Cryptic Wolbachia (Rickettsiales: Rickettsiaceae) Detection and Prevalence in Culicoides (Diptera: Ceratopogonidae) Midge Populations in the United States

Journal of Medical Entomology ◽

10.1093/jme/tjaa003 ◽

2020 ◽

Vol 57 (4) ◽

pp. 1262-1269 ◽

Cited By ~ 4

Author(s):

Hunter Covey ◽

Rafe H Hall ◽

Alyssa Krafsur ◽

Megan L Matthews ◽

Phillip T Shults ◽

...

Keyword(s):

United States ◽

Vector Control ◽

Disease Transmission ◽

The United States ◽

Hemorrhagic Disease ◽

Human Pathogens ◽

Control Approach ◽

16S Gene ◽

Culicoides Sonorensis

Abstract Culicoides midges vector numerous veterinary and human pathogens. Many of these diseases lack effective therapeutic treatments or vaccines to limit transmission. The only effective approach to limit disease transmission is vector control. However, current vector control for Culicoides midges is complicated by the biology of many Culicoides species and is not always effective at reducing midge populations and impacting disease transmission. The endosymbiont Wolbachia pipientis Hertig may offer an alternative control approach to limit disease transmission and affect Culicoides populations. Here the detection of Wolbachia infections in nine species of Culicoides midges is reported. Infections were detected at low densities using qPCR. Wolbachia infections were confirmed with the sequencing of a partial region of the 16S gene. Fluorescence in situ hybridization of Culicoides sonorensis Wirth and Jones adults and dissected ovaries confirm the presence of Wolbachia infections in an important vector of Bluetongue and Epizootic hemorrhagic disease viruses. The presence of Wolbachia in Culicoides populations in the United States suggests the need for further investigation of Wolbachia as a strategy to limit transmission of diseases vectored by Culicoides midges.

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Significance of a Positive Toxoplasma Immunoglobulin M Test Result in the United States

Journal of Clinical Microbiology ◽

10.1128/jcm.01663-15 ◽

2015 ◽

Vol 53 (11) ◽

pp. 3601-3605 ◽

Cited By ~ 39

Author(s):

Reshika Dhakal ◽

Kiran Gajurel ◽

Christelle Pomares ◽

Jeanne Talucod ◽

Cynthia J. Press ◽

...

Keyword(s):

United States ◽

Chronic Infection ◽

Serological Test ◽

Acute Infection ◽

The United States ◽

Immunoglobulin M ◽

Reference Laboratory ◽

Test Results ◽

Chronic Infections ◽

Content Type

A positiveToxoplasmaimmunoglobulin M (IgM) result is often interpreted as a marker of an acute infection. However, IgM can persist for several years, andToxoplasmacommercial IgM diagnostic test kits can yield a number of false-positive results. For these reasons, a chronicToxoplasmainfection can be erroneously classified as an acute infection, resulting in serious adverse consequences, especially in pregnant women, leading to emotional distress and unnecessary interventions, including termination of pregnancy. Interpretation ofToxoplasmaserology at a reference laboratory can help differentiate a recently acquired infection from a chronic infection. Serological test results for 451 patients with positiveToxoplasmaIgM and IgG test results obtained at nonreference laboratories (NRLs) that were referred to Palo Alto Medical Foundation Toxoplasma Serology Laboratory (PAMF-TSL) to determine whether the patient was acutely or chronically infected were retrospectively reviewed. PAMF-TSL results established that of the 451 patients, 335 (74%) had a chronic infection, 100 (22%) had an acute infection, and 7 (2%) were not infected, and for 9 (2%), results were indeterminate. PositiveToxoplasmaIgM and IgG test results obtained at NRLs cannot accurately distinguish between acute and chronic infections. To do so, testing at reference laboratories is required, as mandated in 1997 in a letter from the Food and Drug Administration (FDA) to clinicians and laboratories in the United States.

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