Discovery of Peptidic Ligands against the SARS-CoV-2 Spike Protein and Their Use in the Development of a Highly Sensitive Personal Use Colorimetric COVID-19 Biosensor.

In addition to efficacious vaccines and antiviral therapeutics, reliable and flexible in-home personal use diagnostics for the detection of viral antigens are needed for effective control of the COVID-19 pandemic. Despite the approval of several PCR-based and affinity-based in-home COVID-19 testing kits, many of them suffer from problems such as a high false-negative rate, long waiting time, and short storage period. Using the enabling one-bead-one-compound (OBOC) combinatorial technology, several peptidic ligands with a nanomolar binding affinity toward the SARS-CoV-2 spike protein (S-protein) were successfully discovered. Taking advantage of the high surface area of porous nanofibers, immobilization of these ligands on nanofibrous membranes allows the development of personal use sensors that can achieve low nanomolar sensitivity in the detection of the S-protein in saliva. This simple biosensor employing naked-eye reading exhibits detection sensitivity comparable to some of the current FDA-approved home detection kits. Furthermore, the ligand used in the biosensor was found to detect the S-protein derived from both the original strain and the Delta variant. The workflow reported here may enable us to rapidly respond to the development of home-based biosensors against future viral outbreaks.

Regulatory Approach to Point-of-Care/At-Home Testing in the United States.

The Clinical Laboratory Improvement Amendments (CLIA) classifications were activated in the 1990s in partnership with the Centers for Medicare and Medicaid Services and Food and Drug Administration and included waived, moderate, and high complexity testing. The waived section of CLIA certificates allows laboratories to perform testing of analytes and methods of samples by the Food and Drug Administration. During the COVID-19 pandemic, many molecular or antigen laboratory testing methods for COVID-19 virus were quickly approved by emergency use authorization. Waived testing is now done in highly complex, moderately complex, and waived testing laboratories, and some at-home testing.

Impacts of Utensil Conditions on Consumer Perception and Acceptance of Food Samples Evaluated under In-Home Testing during the COVID-19 Pandemic.

Sensory professionals are looking for alternative ways to conduct laboratory sensory testing, especially central location testing (CLT), during the COVID-19 pandemic. One way could be conducting CLTs at home (i.e., in-home testing). It is questionable whether food samples under in-home testing should be presented in uniform utensils, as it does so under laboratory sensory testing. This study aimed to determine whether utensil conditions could affect consumer perception and acceptance of food samples evaluated under in-home testing. Sixty-eight participants (40 females and 28 males) prepared chicken-flavored ramen noodle samples and evaluated them for attribute perception and acceptance, under two utensil conditions, using either their utensils ("Personal") or uniform utensils provided ("Uniform"). Participants also rated their liking of forks/spoons, bowls, and eating environments, respectively, and attentiveness to sensory evaluation under each utensil condition. Results of the in-home testing showed that participants liked ramen noodle samples and their flavors under the "Personal" condition significantly more than under the "Uniform" condition. Ramen noodle samples evaluated under the "Uniform" condition were significantly higher in terms of saltiness than those evaluated under the "Personal" condition. Participants liked forks/spoons, bowls, and eating environments used under the "Personal" condition significantly more than those used under the "Uniform" condition. While overall likings of ramen noodle samples, evaluated under the "Personal" condition, significantly increased with an increase in hedonic ratings of forks/spoons or bowls, such significant correlations were not observed under the "Uniform" condition. In other words, providing uniform utensils (forks, spoons, and bowls) to participants in the in-home testing can reduce the influences of utensils on consumer likings of ramen noodle samples evaluated at home. In conclusion, this study suggests that sensory professionals should consider providing uniform utensils when they want to focus solely on consumer perception and acceptance of food samples by minimizing influences of environmental contexts, especially utensils, in the "in-home" testing.

Highlighting and addressing barriers to widespread adaptation of HIV self-testing in the United States.

INTRODUCTION: HIV self-testing (HIVST), whereby an individual performs and interprets their own rapid screening test at home, is another tool to increase the proportion of at-risk individuals who know their status. Globally, HIVST has rapidly been adopted through global partnerships to ensure equitable access to tests in low- and middle-income countries (LMIC). AREA COVERED: This review discusses the regulatory burdens of HIV self-testing within the United States while examining the use of HIV self-tests on a global scale. While the United States only has one approved HIV self-test, numerous tests have been prequalified by the WHO. EXPERT OPINION: Despite the US Food and Drug Administration (FDA) clearance of the first and only self-test in 2012, there have been no other tests that have undergone FDA consideration due to regulatory barriers. This, in turn, has stifled market competition. Despite existing evidence that such programs are an innovative approach to testing hesitant or hard-to-reach populations, high individual test cost and bulky packaging make large-scale, mail-out, and HIV self-testing programs expensive. COVID-19 pandemic has accelerated the public demand for self-testing - HIV self-test programs should capitalize on this to increase the proportion of at-risk people who know their status and are linked to care to contribute to ending the HIV epidemic.

Validity of self-testing at home with rapid SARS-CoV-2 antibody detection by lateral flow immunoassay.

BACKGROUND: We explore SARS-CoV-2 antibody lateral flow immunoassay (LFIA) performance under field conditions compared to laboratory-based electrochemiluminescence immunoassay (ECLIA) and live virus neutralisation. METHODS: In July 2021, 3758 participants performed, at home, a self-administered Fortress LFIA on finger-prick blood, reported and submitted a photograph of the result, and provided a self-collected capillary blood sample for assessment of IgG antibodies using the Roche Elecsys® Anti-SARS-CoV-2 ECLIA. We compared the self-reported LFIA result to the quantitative ECLIA and checked the reading of the LFIA result with an automated image analysis (ALFA). In a subsample of 250 participants, we compared the results to live virus neutralisation. RESULTS: Almost all participants (3593/3758, 95.6%) had been vaccinated or reported prior infection. Overall, 2777/3758 (73.9%) were positive on self-reported LFIA, 2811/3457 (81.3%) positive by LFIA when ALFA-reported, and 3622/3758 (96.4%) positive on ECLIA (using the manufacturer reference standard threshold for positivity of 0.8 U ml-1). Live virus neutralisation was detected in 169 of 250 randomly selected samples (67.6%); 133/169 were positive with self-reported LFIA (sensitivity 78.7%; 95% CI 71.8, 84.6), 142/155 (91.6%; 86.1, 95.5) with ALFA, and 169 (100%; 97.8, 100.0) with ECLIA. There were 81 samples with no detectable virus neutralisation; 47/81 were negative with self-reported LFIA (specificity 58.0%; 95% CI 46.5, 68.9), 34/75 (45.3%; 33.8, 57.3) with ALFA, and 0/81 (0%; 0.0, 4.5) with ECLIA. CONCLUSIONS: Self-administered LFIA is less sensitive than a quantitative antibody test, but the positivity in LFIA correlates better than the quantitative ECLIA with virus neutralisation.

miSHERLOCK Non-invasive Home Testing of COVID-19

The emergence of various SARS-CoV-2 mutants accelerates the development of COVID-19 pandemic and seriously affects the normal society. Increasing the efficiency of virus screening and the ability to identify new mutants is thus crucial to the pandemic prevention and control. Recently, on Science Advances, Professor James J. Collins et al. developed a low-cost (similar to $ 15), rapid (similar to 60 min) and portable in-home detection device 14 SARS-CoV-2 and its variants based on the CRISPR/Cas technology, which was expected to provide a new option for rapid screening of SARS-CoV-2.

At-home Testing and Risk Factors for Acquisition of SARS-CoV-2 Infection in a Major US Metropolitan Area.

Background: Unbiased assessment of the risks associated with acquisition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical to informing mitigation efforts during pandemics. The objective of our study was to understand the risk factors for acquiring coronavirus disease 2019 (COVID-19) in a large prospective cohort of adult residents in a large US metropolitan area. Methods: We designed a fully remote longitudinal cohort study involving monthly at-home SARS-CoV-2 polymerase chain reaction (PCR) and serology self-testing and monthly surveys. Results: Between October 2020 and January 2021, we enrolled 10 289 adults reflective of the Boston metropolitan area census data. At study entry, 567 (5.5%) participants had evidence of current or prior SARS-CoV-2 infection. This increased to 13.4% by June 15, 2021. Compared with Whites, Black non-Hispanic participants had a 2.2-fold greater risk of acquiring COVID-19 (hazard ratio [HR], 2.19; 95% CI, 1.91-2.50; P < .001), and Hispanics had a 1.5-fold greater risk (HR, 1.52; 95% CI, 1.32-1.71; P < .016). Individuals aged 18-29, those who worked outside the home, and those living with other adults and children were at an increased risk. Individuals in the second and third lowest disadvantaged neighborhood communities were associated with an increased risk of acquiring COVID-19. Individuals with medical risk factors for severe disease were at a decreased risk of SARS-CoV-2 acquisition. Conclusions: These results demonstrate that race/ethnicity and socioeconomic status are the biggest determinants of acquisition of infection. This disparity is significantly underestimated if based on PCR data alone, as noted by the discrepancy in serology vs PCR detection for non-White participants, and points to persistent disparity in access to testing. Medical conditions and advanced age, which increase the risk for severity of SARS-CoV-2 disease, were associated with a lower risk of COVID-19 acquisition, suggesting the importance of behavior modifications. These findings highlight the need for mitigation programs that overcome challenges of structural racism in current and future pandemics.

Remote videolink observation of model home sampling and home testing devices to simplify usability studies for point-of-care diagnostics [version 1;peer review: awaiting peer review]

Both home sample collection and home testing using rapid point-of-care diagnostic devices can offer benefits over attending a clinic/hospital to be tested by a healthcare professional. Usability is critical to ensure that in-home sampling or testing by untrained users does not compromise analytical performance. Usability studies can be laborious and rely on participants attending a research location or a researcher visiting homes;neither has been appropriate during COVID-19 outbreak control restrictions. We therefore developed a remote research usability methodology using videolink observation of home users. This avoids infection risks from home visits and ensures the participant follows the test protocol in their home environment. In this feasibility study, volunteers were provided with models of home blood testing and home blood sampling kits including a model lancet, sampling devices for dried blood spot collection, and model lateral flow device. After refining the study protocol through an initial pilot (n = 7), we compared instructions provided either as written instructions (n = 5), vs addition of video instructions (n = 5), vs written and video instructions plus videolink supervision by the researcher (n = 5). All users were observed via video call to define which test elements could be assessed remotely. All 22 participants in the study accessed the video call and configured their videolink allowing the researcher to clearly observe all testing tasks. The video call allowed the researcher to assess distinct errors during use including quantitative (volume of blood) and qualitative (inaccurate interpretation of results) errors many of which could compromise test accuracy. All participants completed the tasks and returned images of their completed tests (22/22) and most returned completed questionnaires (20/22). We suggest this remote observation via videolink methodology is a simple, rapid and powerful methodology to assess and optimise usability of point-of-care testing methods in the home setting.

Loss of olfactory sensitivity is an early and reliable marker for COVID-19.

Detection of early and reliable symptoms is important in relation to limiting the spread of an infectious disease. For COVID-19, the most specific symptom is either losing or experiencing reduced olfactory functions. Anecdotal evidence suggests that olfactory dysfunction is also one of the earlier symptoms of COVID-19, but objective measures supporting this notion are currently missing. To determine whether olfactory loss is an early sign of COVID-19, we assessed available longitudinal data from a web-based interface enabling individuals to test their sense of smell by rating the intensity of selected household odors. Individuals continuously used the interface to assess their olfactory functions and at each login, in addition to odor ratings, recorded their symptoms and results from potential COVID-19 test. A total of 205 COVID-19-positive individuals and 156 pseudo-randomly matched control individuals lacking positive test provided longitudinal data which enabled us to assess olfactory functions in relation to their test result date. We found that odor intensity ratings started to decline in the COVID-19 group as early as 6 days prior to the test result date (±1.4 days). Symptoms, such as sore throat, aches, and runny nose appear around the same point in time; however, with a lower predictability of a COVID-19 diagnosis. Our results suggest that olfactory sensitivity loss is an early symptom but does not appear before other related COVID-19 symptoms. Olfactory loss is, however, more predictive of a COVID-19 diagnosis than other early symptoms.

Health Consumer Engagement, Enablement, and Empowerment in Smartphone-Enabled Home-Based Diagnostic Testing for Viral Infections: Mixed Methods Study.

BACKGROUND: Health consumers are increasingly taking a more substantial role in decision-making and self-care regarding their health. A range of digital technologies is available for laypeople to find, share, and generate health-related information that supports their health care processes. There is also innovation and interest in home testing enabled by smartphone technology (smartphone-supported home testing [smart HT]). However, few studies have focused on the process from initial engagement to acting on the test results, which involves multiple decisions. OBJECTIVE: This study aimed to identify and model the key factors leading to health consumers' engagement and enablement associated with smart HT. We also explored multiple levels of health care choices resulting from health consumer empowerment and activation from smart HT use. Understanding the factors and choices associated with engagement, enablement, empowerment, and activation helps both research and practice to support the intended and optimal use of smart HT. METHODS: This study reports the findings from 2 phases of a more extensive pilot study of smart HT for viral infection. In these 2 phases, we used mixed methods (semistructured interviews and surveys) to shed light on the situated complexities of health consumers making autonomous decisions to engage with, perform, and act on smart HT, supporting the diagnostic aspects of their health care. Interview (n=31) and survey (n=282) participants underwent smart HT testing for influenza in earlier pilot phases. The survey also extended the viral infection context to include questions related to potential smart HT use for SARS-CoV-2 diagnosis. RESULTS: Our resulting model revealed the smart HT engagement and enablement factors, as well as choices resulting from empowerment and activation. The model included factors leading to engagement, specifically various intrinsic and extrinsic influences. Moreover, the model included various enablement factors, including the quality of smart HT and the personal capacity to perform smart HT. The model also explores various choices resulting from empowerment and activation from the perspectives of various stakeholders (public vs private) and concerning different levels of impact (personal vs distant). CONCLUSIONS: The findings provide insight into the nuanced and complex ways health consumers make decisions to engage with and perform smart HT and how they may react to positive results in terms of public-private and personal-distant dimensions. Moreover, the study illuminates the role that providers and smart HT sources can play to better support digitally engaged health consumers in the smart HT decision process.

The Coronavirus Disease 2019 Spatial Care Path: Home, Community, and Emergency Diagnostic Portals.

This research uses mathematically derived visual logistics to interpret COVID-19 molecular and rapid antigen test (RAgT) performance, determine prevalence boundaries where risk exceeds expectations, and evaluate benefits of recursive testing along home, community, and emergency spatial care paths. Mathematica and open access software helped graph relationships, compare performance patterns, and perform recursive computations. Tiered sensitivity/specificity comprise: (T1) 90%/95%; (T2) 95%/97.5%; and (T3) 100%/≥99%, respectively. In emergency medicine, median RAgT performance peaks at 13.2% prevalence, then falls below T1, generating risky prevalence boundaries. RAgTs in pediatric ERs/EDs parallel this pattern with asymptomatic worse than symptomatic performance. In communities, RAgTs display large uncertainty with median prevalence boundary of 14.8% for 1/20 missed diagnoses, and at prevalence > 33.3-36.9% risk 10% false omissions for symptomatic subjects. Recursive testing improves home RAgT performance. Home molecular tests elevate performance above T1 but lack adequate validation. Widespread RAgT availability encourages self-testing. Asymptomatic RAgT and PCR-based saliva testing present the highest chance of missed diagnoses. Home testing twice, once just before mingling, and molecular-based self-testing, help avoid false omissions. Community and ER/ED RAgTs can identify contagiousness in low prevalence. Real-world trials of performance, cost-effectiveness, and public health impact could identify home molecular diagnostics as an optimal diagnostic portal.

Flu@home: the Comparative Accuracy of an At-Home Influenza Rapid Diagnostic Test Using a Prepositioned Test Kit, Mobile App, Mail-in Reference Sample, and Symptom-Based Testing Trigger.

At-home testing with rapid diagnostic tests (RDTs) for respiratory viruses could facilitate early diagnosis, guide patient care, and prevent transmission. Such RDTs are best used near the onset of illness when viral load is highest and clinical action will be most impactful, which may be achieved by at-home testing. We evaluated the diagnostic accuracy of the QuickVue Influenza A+B RDT in an at-home setting. A convenience sample of 5,229 individuals who were engaged with an on-line health research platform were prospectively recruited throughout the United States. "Flu@home" test kits containing a QuickVue RDT and reference sample collection and shipping materials were prepositioned with participants at the beginning of the study. Participants responded to daily symptom surveys. If they reported experiencing cough along with aches, fever, chills, and/or sweats, they used their flu@home kit following instructions on a mobile app and indicated what lines they saw on the RDT. Of the 976 participants who met criteria to use their self-collection kit and completed study procedures, 202 (20.7%) were positive for influenza by qPCR. The RDT had a sensitivity of 28% (95% CI = 21 to 36) and specificity of 99% (98 to 99) for influenza A, and 32% (95% CI = 20 to 46) and 99% (95% CI = 98 to 99), for influenza B. Our results support the concept of app-supported, prepositioned at-home RDT kits using symptom-based triggers, although it cannot be recommended with the RDT used in this study. Further research is needed to determine ways to improve the accuracy and utility of home-based testing for influenza.

Inflection Point: The Role of Testing in Admissions Decisions in a Postpandemic Environment

In 2020, the onset of COVID-19 greatly restricted access to admissions testing in higher education and required innovative solutions and flexibility such as at home testing with remote proctoring, reducing testing time, pop-up locations, and additional testing dates. Increased focus on social justice, diversity, and fairness continued to concern admissions professionals during this time. This article is intended to provide an update (Camara) on admissions testing as we enter 2022, documenting enhancements and changes across testing programs. In addition, we report recent data and findings on applications, enrollment, and test taking, as well as the prevalence of test optional and test blind policies and its impact on score sending in undergraduate, graduate, business, law, and medical schools. It is important to note that many questions remain unanswered. Our original intent was to include more information on the impact of test-optional polices on diversity as we thought the pandemic would be in the rear-view mirror by now. Given the lingering effects of the pandemic, it will be critical to evaluate the impact of these policies changes on the entering class of 2021 and beyond as those data become available.

The Implementation and Acceptability of a Combined Mobile Application with a COVID-19 at-Home Test Kit.

Introduction: Testing facilities for COVID-19 were stood up around the country during the pandemic, but could not handle the demand. This study aimed to combine a mobile application (App) with an at-home test kit to facilitate home-based testing. Methods: After integrating an App with an at-home testing service, we measured the time between sample collection and notification of results. We recruited 92 volunteers to utilize the platform. Results: Sixty-one percent (55/92) responded to the survey. Median sample collection-to-result time was 2.2 days (IQR = 1.3-3.2). Eighty-two percent (45/55) found the self-test kit and App easy to use. Eighty-four percent agreed that the combined solution is an acceptable way to receive health care services. Discussion: Decreasing testing time and providing timely test results improve care access and decrease the risk of infection. Combining a tailored App with an at-home testing service is a feasible solution to reaching that goal.

Home testing for COVID-19 and other virus outbreaks: The complex system of translating to communities.

Home testing is an emerging innovation that can enable nations and health care systems to safely and efficiently test large numbers of patients to manage COVID-19 and other viral outbreaks.  In this position paper, we explore the process of moving home testing across the translational continuum from labs to households, and ultimately into practice and communities for optimal public health impact. We focus on the four translational science drivers to accelerate the implementation of systems-wide home testing programmes 1) collaboration and team science, 2) technology, 3) multilevel interventions, and 4) knowledge integration. We use the Socio Ecological Model (SEM) as a framework to illustrate our vision for the ideal future state of a comprehensive system of stakeholders utilising tech-enabled home testing for COVID-19 and other virus outbreaks, and we suggest SEM as a tool to address key translational readiness and response questions.

Detection of SARS-CoV-2 at the point of care.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of COVID-19. Testing for SARS-CoV-2 infection is a critical element of the public health response to COVID-19. Point-of-care (POC) tests can drive patient management decisions for infectious diseases, including COVID-19. POC tests are available for the diagnosis of SARS-CoV-2 infections and include those that detect SARS-CoV-2 antigens as well as amplified RNA sequences. We provide a review of SARS-CoV-2 POC tests including their performance, settings for which they might be used, their impact and future directions. Further optimization and validation, new technologies as well as studies to determine clinical and epidemiological impact of SARS-CoV-2 POC tests are needed.

Usability and Acceptability of Home-based Self-testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibodies for Population Surveillance.

BACKGROUND: This study assesses acceptability and usability of home-based self-testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies using lateral flow immunoassays (LFIA). METHODS: We carried out public involvement and pilot testing in 315 volunteers to improve usability. Feedback was obtained through online discussions, questionnaires, observations, and interviews of people who tried the test at home. This informed the design of a nationally representative survey of adults in England using two LFIAs (LFIA1 and LFIA2) which were sent to 10 600 and 3800 participants, respectively, who provided further feedback. RESULTS: Public involvement and pilot testing showed high levels of acceptability, but limitations with the usability of kits. Most people reported completing the test; however, they identified difficulties with practical aspects of the kit, particularly the lancet and pipette, a need for clearer instructions and more guidance on interpretation of results. In the national study, 99.3% (8693/8754) of LFIA1 and 98.4% (2911/2957) of LFIA2 respondents attempted the test and 97.5% and 97.8% of respondents completed it, respectively. Most found the instructions easy to understand, but some reported difficulties using the pipette (LFIA1: 17.7%) and applying the blood drop to the cassette (LFIA2: 31.3%). Most respondents obtained a valid result (LFIA1: 91.5%; LFIA2: 94.4%). Overall there was substantial concordance between participant and clinician interpreted results (kappa: LFIA1 0.72; LFIA2 0.89). CONCLUSIONS: Impactful public involvement is feasible in a rapid response setting. Home self-testing with LFIAs can be used with a high degree of acceptability and usability by adults, making them a good option for use in seroprevalence surveys.

Where will telemedicine go from here?

The COVID-19 pandemic accelerated the adoption of telemedicine internationally. The reproductive clinics that thrived in this tumultuous time had access to fully electronic medical records with user-friendly telehealth platforms and remote support staff for physicians. However, complete transition from in-person visits to telehealth uncovered many opportunities for innovation. At-home semen testing is not yet widely recognized, and patients still require an in-person visit for ultrasounds, procedures, and physical examinations. Although emergency policies and waivers have made it easier for providers to legally practice across state borders and receive payments from insurance companies, they vary from state to state and have not been cemented into law. Finally, clinical training for medical students, residents, and fellows has been affected by decreased clinical and surgical volume. However, trainees have also proven to be the most adaptable, quickly shifting to remote learning practices through social media, online surgical atlases, and wide distribution of "virtual visiting professor" lectures. As countries have eased physical distancing guidelines, patients ultimately benefit from having the option of a telehealth appointment. Although there is still much work to be done to improve telehealth, the COVID-19 pandemic has at least proven that it is a safe method of patient care and teaching.

Why the mask? The effectiveness of face masks in preventing the spread of respiratory infections such as COVID-19 - a home testing protocol.

Since the start of the COVID-19 pandemic there has been much debate in the media on whether masks should be worn to stop the spread of the virus. There are two ways in which they could work. Firstly, to protect the person wearing the mask, and secondly, to reduce the likelihood of the person wearing the mask passing the disease on to anyone else. This is not an easy issue to address and many factors come into play such as droplet size, aerosol transmission and the viral load, as well as the specific properties of any given mask. The method used in this study was to measure the change in relative humidity when wearing a mask, compared to no mask, in various scenarios, based on the assumption that as the virus is air-borne the smaller the increase in humidity the less the spread of the virus. The results above show that the use of a mask, excluding some simple home-made ones, significantly reduces the spread of humidity. However, their effectiveness is device specific and needs to be considered in greater detail for each type of mask, especially the direction of escaping air when forward flow is blocked.

Suitability and Sufficiency of Telehealth Clinician-Observed, Participant-Collected Samples for SARS-CoV-2 Testing: The iCollect Cohort Pilot Study.

BACKGROUND: The severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic calls for expanded opportunities for testing, including novel testing strategies such as home-collected specimens. OBJECTIVE: We aimed to understand whether oropharyngeal swab (OPS), saliva, and dried blood spot (DBS) specimens collected by participants at home and mailed to a laboratory were sufficient for use in diagnostic and serology tests of SARS-CoV-2. METHODS: Eligible participants consented online and were mailed a participant-collection kit to support collection of three specimens for SARS-CoV-2 testing: saliva, OPS, and DBS. Participants performed the specimen collection procedures during a telehealth video appointment while clinical observers watched and documented the suitability of the collection. The biological sufficiency of the specimens for detection of SARS-CoV-2 by reverse transcriptase-polymerase chain reaction and serology testing was assessed by laboratorians using visual inspection and quantification of the nucleic acid contents of the samples by ribonuclease P (RNase P) measurements. RESULTS: Of the enrolled participants,153/159 (96.2%) returned their kits, which were included in this analysis. All these participants attended their video appointments. Clinical observers assessed that of the samples collected, 147/153 (96.1%) of the saliva samples, 146/151 (96.7%) of the oropharyngeal samples, and 135/145 (93.1%) of the DBS samples were of sufficient quality for submission for laboratory testing; 100% of the OPS samples and 98% of the saliva samples had cycle threshold values for RNase P <30, indicating that the samples contained sufficient nucleic acid for RNA-PCR testing for SARS-CoV-2. CONCLUSIONS: These pilot data indicate that most participant-collected OPS, saliva, and DBS specimens are suitable and sufficient for testing for SARS-CoV-2 RNA and serology. Clinical observers rated the collection of specimens as suitable for testing, and visual and quantitative laboratory assessment indicated that the specimens were biologically sufficient. These data support the utility of participant-collected and mailed-in specimens for SARS-CoV-2 testing. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19054.