scholarly journals Feasibility of large-scale population testing for SARS-CoV-2 detection by self-testing at home

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Paula Iruzubieta ◽  
Tatiana Fernández-Lanas ◽  
Laura Rasines ◽  
Lorena Cayon ◽  
Ana Álvarez-Cancelo ◽  
...  

AbstractThe simplicity and low cost of rapid point-of-care tests greatly facilitate large-scale population testing, which can contribute to controlling the spread of the COVID-19 virus. We evaluated the applicability of a self-testing strategy for SARS-CoV2 in a population-based, cross-sectional study in Cantabria, Spain, between April and May 2020. For the self-testing strategy, participants received the necessary material for the self-collection of blood and performance of a rapid antibody test using lateral flow immunoassay at home without the supervision of healthcare personnel. A total of 1,022 participants were enrolled. Most participants correctly performed the COVID-19 self-test the first time (91.3% [95% CI 89.4–92.9]). Only a minority of the participants (0.7%) needed the help of healthcare personnel, while 6.9% required a second kit delivery, for a total valid test result in 96.9% of the participants. Incorrect use of the self-test was not associated with the educational level, age over 65, or housing area. Prevalence of IgG antibodies against SARS-CoV2 for subjects with a valid rapid test result was 3.1% (95% CI 2.2–4.4), similar to the seroprevalence result obtained using a conventional approach carried out by healthcare professionals. In conclusion, COVID-19 self-testing should be considered as a screening tool.

2018 ◽  
Author(s):  
Nitika Pant Pai ◽  
Megan Smallwood ◽  
Laurence Desjardins ◽  
Alexandre Goyette ◽  
Krisztian G Birkas ◽  
...  

BACKGROUND Although HIV self-testing strategies have been recommended by the World Health Organization, HIV self-tests are not yet approved in Canada. Currently approved HIV self-tests offer toll-free lines that are insufficient for initiating expedited linkages to counseling and care, accurate interpretation, and support during HIV self-testing. We developed an innovative, multilingual software app called HIVSmart! to plug these gaps. OBJECTIVE This study aimed to test our app-optimized oral HIV self-testing strategy for feasibility in men who have sex with men (MSM) who presented to test at a large sexual health clinic (Clinique Médicale L’Actuel) in Montreal. METHODS Between July 2016 and February 2017, we offered a strategy consisting of the OraQuick In-Home HIV Test (an investigational device) and a tablet installed with the HIVSmart! app to study participants, who presented at a private office in the clinic, mimicking an unsupervised home environment. We evaluated the strategy for its feasibility, acceptability, and preference. Using the HIVSmart! app, participants were guided through the self-testing process. We determined feasibility with a metric defined as the completion rate, which consisted of the following 3 steps: (1) self-test conduct; (2) self-test interpretation; and (3) linkages to care. Participants independently performed, interpreted, recorded their self-test and result, engaged in pre- and posttest counseling, and sought linkages to care. Laboratory tests (p24, Western Blot, and RNA), as per country algorithms, were expedited, and linkages based on the rapid test status were arranged. RESULTS Mean age of the 451 participants enrolled was 34 (range, 18-73) years. Of all participants, 97.1% (438/451) completed and submitted the survey through the HIVSmart! app. In total, 84.7% (371/438) of the participants were well educated (beyond high school) and 52.5% (230/438) had been tested within the past 6 months. Of the 451, 11.5% (52/451) were on pre-exposure prophylaxis. Feasibility (completion rate), an average proportion of the 3 steps, was computed to be 96.6% (419/451). The acceptability of the strategy was high at 98.5% (451/458). A majority of the participants (448/451, 99.3%) were found to be self-tested and lab-confirmed negative and were counseled after self- and rapid tests. In total, 0.7% (3/451) of the participants who self-tested positive and were lab-confirmed positive were linked to a physician within the same day. Furthermore, 98.8% (417/422) of the participants found the app to be useful and 94.0% (424/451) were willing to recommend it to a friend or partner. CONCLUSIONS The HIVSmart! app-optimized strategy was feasible, accepted, and preferred by an educated, urban MSM population of Montreal. With the app, participants were able to perform, interpret, store results, and get rapidly linked to care. The HIVSmart!-optimized, self-testing strategy could be adapted and contextualized to many at-risk populations within Canada and worldwide, thereby maximizing its public health impact.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1935-1935
Author(s):  
Alicia Rovo ◽  
Claudia Baierlein-Leimbach ◽  
Cesare Medri ◽  
Ioannis Chanias ◽  
Loreen Errass ◽  
...  

Abstract Introduction: Patients with polycythemia vera (PV) have an increased risk of morbidity and mortality from thromboembolic events and cardiovascular disease, particularly for hematocrit (Hct) levels > 45% (Marchioli et al., 2013). Maintaining Hct < 45% is therefore important to reduce these risks. A device that patients can use to frequently monitor their own Hct levels could provide a detailed picture of the change in Hct over time, enable timely clinical visits and disease management, reduce disease burden, and increase patients' quality of life (QoL). A meter to measure hemoglobin (Hb) and Hct that has been approved for medical professional use (StatStrip Xpress ® 2 Hb/Hct meter, Nova Biomedical Corporation) has potential as an at-home, self-testing device. Purpose: To carry out a proof-of-concept study in clinical practice to test the accuracy of the StatStrip Xpress 2 Hb/Hct meter, to evaluate its feasibility for patient self-testing, and to assess its impact on patient-reported outcomes. Methods: Adults (aged > 18 years) who had PV (according to the World Health Organization 2016 criteria), or conditions with Hct < 35% or Hct > 50%, who required monitoring of Hct/Hb values in clinical practice and who provided informed consent were enrolled from two Swiss centers in this observational study. During each routine visit, patients collected and analyzed a finger-prick blood sample using StatStrip Xpress 2 Hb/Hct (self-test) without guidance or intervention from healthcare professionals (HCPs); HCPs then repeated this test (professional test). At each visit, HCPs also collected and analyzed a venous blood sample using a laboratory hematology analyzer (Sysmex), and patients completed a 15-minute questionnaire about use of the self-test device. The primary endpoint was mean difference in absolute percentage points between Hct values from the professional test and the analyzer (mdiff, 90% confidence interval [CI]; Spearman correlation [r]). Secondary endpoints included mdiff for Hct (%) and Hb (g/dl) between values obtained from the self-test and professional test, and the self-test and analyzer. Other endpoints included the correlation between the professional test Hct values and other blood cell counts. The study was approved by local ethics committees. Results: Blood measurements from 68 visits for 60 patients (PV = 32; other conditions with Hct < 35% or > 50% = 28) were included in the analysis. For the primary endpoint, Hct values were very similar for the analyzer and professional test (66 data points after removal of 1 outlier; mdiff = 0.1% [CI: ‒0.5-0.8]; r = 0.95, p < 0.001). Importantly, Hct results were also similar for the self-test and professional test (63 data points after removal of 2 outliers; mdiff = -0.2% [CI: ‒0.98-0.5]; r = 0.93, p < 0.001) and the analyzer and self-test (64 data points after removal of 2 outliers; mdiff = 0.1% [CI: ‒0.6-0.8]; r = 0.93, p < 0.001). Similar results were obtained for Hb measurements across the tests. There was no correlation between the accuracy of Hct values from the professional test (vs the analyzer) and blood cell counts, but this should be interpreted with caution because there was a limited number of patients with extreme white blood cell and platelet counts. There was no influence of sex (male/female), age (≤ 75 years/> 75 years) or, in the case of patients with PV, time from diagnosis on the results. Responses to the patient questionnaire showed that 92% of patients were satisfied or very satisfied with the self-test device, 100% found it easy to use, and 97% were willing to start using it at home. Of patients with PV, 71% stated that using a self-testing device would make them feel safer and 56% felt that it would have a positive effect on their QoL. Conclusions: This study demonstrates the accuracy of the StatStrip Xpress 2 Hct/Hb meter vs a laboratory analyzer for measuring Hct and Hb levels. Importantly, it shows that measurements taken by patients are as accurate as those taken by HCPs. These findings highlight the potential benefits of introducing an instrument for at-home self-testing to the management of patients with PV or other hematological conditions that require regular Hct/Hb monitoring. Benefits to patients may include increased QoL, improved clinical outcomes, and reduced morbidity and mortality through timely clinical action. In addition, fewer outpatient appointments may mean reduced healthcare costs. Figure 1 Figure 1. Disclosures Rovo: Novartis: Honoraria; BMS: Honoraria; Amgen: Other: Financial support for congresses and conference travel; AstraZeneca: Other; Swedish Orphan Biovitrum AG: Honoraria; AG Alexion: Honoraria; OrPhaSwiss GmbH: Honoraria; AstraZeneca: Honoraria; BMS: Other; Sanofi: Other; Roche: Other; Novartis: Research Funding; CSL Behring: Research Funding; AG Alexion: Research Funding. Baierlein-Leimbach: Novartis Pharma Schweiz AG: Current Employment. Triemer: Novartis Pharma Schweiz AG: Current Employment. McCarthy-Pontier: Novartis Pharma Schweiz AG: Current Employment. Lehmann: AbbVie: Honoraria; Novartis: Research Funding; Janssen: Honoraria; Swedish Orphan Biovitrum AG: Honoraria; Janssen: Other; Roche: Other; Abbvie: Other: Financial support for congress and conference travel ; Amgen: Other: Financial support for congress and conference travel ; Celgene: Research Funding; Incyte: Honoraria; BMS: Honoraria; Amgen: Honoraria.


2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S426-S426
Author(s):  
Nitika Pant Pai ◽  
Megan Smallwood ◽  
Laurence Desjardins ◽  
Alexandre Goyette ◽  
Anne-Fanny Vassal ◽  
...  

Abstract Background Although HIV self-tests are recommended by the WHO, they are not yet approved in Canada. Service delivery gaps such as linkages to counseling and care remain unachieved by offering self-tests without adequate support. In this first Canadian study, we evaluated the feasibility of operationalizing an innovative HIVSmart! app-optimized oral HIV self-testing strategy in men who have sex with men (MSM), presenting at a large sexual health clinic in Montreal. Methods Between July 2016 to February 2017, participants were offered the OraQuick In-Home HIV Test, and a tablet installed with the HIVSmart! app, at a private office in the clinic to simulate an unsupervised home environment. With the HIVSmart! app, participants independently performed and interpreted self-tests, and were linked to in-person post-test counseling and care. Self-test results were confirmed by laboratory tests (p24, Western Blot, RNA as needed). Results The mean age of the 451 participants was 34 years (18–73); 85% were well educated (beyond high school, n = 371/438); 53% (230/438) were frequent testers (past 6 months), and 13% were on PrEP (52/451). 99% (417/422) of participants found the HIVSmart! app helpful in guiding them through the self-testing procedure; 93% (418/451) of participants interpreted their tests accurately; and 94% (395/419) stated they would recommend the app-optimized self-testing strategy to their partners. Feasibility (completion rate of self-testing) was 93% (419/451), and acceptability of the strategy was high at 99% (451/458). All HIV self-test negative participants (448/451, 100%) were counseled following the self-test. Three participants self-tested positive, were confirmed HIV positive (0.7% prevalence), and were rapidly linked to care with a physician. Conclusion The HIVSmart! app-optimized strategy was feasible, and highly accepted by an educated, frequently testing, urban MSM population of Montréal. With the app, participants were able to interpret their test results accurately and were rapidly linked to care. Innovations like HIVSmart! which engage, aid, and facilitate linkages to care, can be adapted to suit the needs of many populations in Canada and internationally, maximizing global impact through reverse innovation. Disclosures All authors: No reported disclosures.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S654-S654
Author(s):  
Matthew Thompson ◽  
Monica L Zigman Suchsland ◽  
Victoria Lyon ◽  
Enos Kline ◽  
ShiChu Huang ◽  
...  

Abstract Background Seasonal influenza (flu) occurs annually, causing disease with substantial morbidity and mortality. Currently, flu is suspected from clinical features, but requires a laboratory test to confirm infection. No influenza tests in the United States are approved for use outside of clinical settings. We aimed to determine the accuracy of influenza self-testing using an at-home, app-guided, lateral flow assay compared with a molecular reference standard conducted at a laboratory among adults self-reporting influenza-like illness (ILI). Methods This is an observational study of individuals with self-reported ILI throughout the continental 48 United States recruited from the Flu Near You platform, online marketing, and clinics in the Seattle area. Recruitment took place from March 4 to April 26, 2019. Participants were directed to an iPhone App that determined eligibility, consent, and responses to symptom questions and risk factors. Individuals were mailed a commercially available CLIA-waived influenza lateral flow test to conduct at home, guided by the app, and returned the used test along with a second nasal swab collected in viral transport media to the research team. Influenza testing was performed by RT–PCR on the second nasal swab, as well as the residual fluid from the RDT. Accuracy of home test result (read by the participant), as well as image capture of the lateral flow test strip, were compared with the lab-based reference standard. Results To date, 1127 at-home flu tests were mailed to participants and 711 (63.1%) samples returned to the lab. There were 17 flu-positive results from the rapid diagnostic test for a flu positivity rate of 2.4%. Testing using the reference standard is currently in progress. We will share diagnostic accuracy results once testing of the reference standard is completed. Of the kits returned, 353 (49.7%)had an error recorded, which included errors in return packaging, reference standard, rapid test tube sample, or rapid test strip errors. Conclusion Overall, findings from this study will determine the accuracy of an at-home rapid diagnostic test, and inform more widely research design for evaluating smartphone-enhanced home tests for pathogens. Many samples returned to the lab had a recorded error, suggesting at-home testing requires additional feasibility testing and refinement of the current methods used. Disclosures All authors: No reported disclosures.


2021 ◽  
Author(s):  
Thomas E Grys ◽  
Kathrine McAulay ◽  
Darrell Ingram ◽  
Craig Duffy ◽  
Ashley Williams ◽  
...  

The COVID-19 pandemic has accelerated the pace of innovation around virtual care visits and testing technology. Here we present the SafeSwab (Safe Health Systems, Los Angeles, CA), an integrated, universal sample collection and dispensing device that is designed to minimize user error and enable rapid testing in a point of care or self-testing format. The SafeSwab was used with the Safe Health Systems HealthCheck digital health application to enable self-testing by patients using lateral flow tests for SARS-CoV-2 antigen or for antibodies against SARS-CoV-2. Patients (n=74) using the SafeSwab produced a valid rapid test result in 96% of attempts, and 96% of patients felt confident that they had collected a good sample. The Safe HealthCheck app has an integrated image analysis algorithm, AutoAdapt LFA, that interprets a picture of a rapid test result, and the algorithm interpreted the result correctly 100% of the time. The SafeSwab was found to be versatile and easy to use for both self-collected nasal sampling as well as fingerstick blood sampling. The use of Safe Health Systems HealthCheck app allows an integrated solution for patient instruction and test interpretation


2020 ◽  
Author(s):  
Priya Kannian ◽  
Chandra Lavanya ◽  
Krittika Ravichandran ◽  
Bagavad Gita Jayaraman ◽  
Pasuvaraj Mahanathi ◽  
...  

AbstractIntroductionSARS-CoV2, the aetiological agent of the current COVID-19 pandemic, has been detected in saliva and recently implicated in several oral diseases. Collection of nasopharyngeal swabs (NPS) and detection by reverse transcriptase-polymerase chain reaction (RT-PCR) requires medical / technical expertise. A reliable and easy to handle point-of-care (POC) test is highly desirable, especially to curb transmission. Therefore, in this study, we evaluated a commercially available POC rapid antigen test (RAT) for the detection of SARS-CoV2 antigens in the saliva of RT-PCR confirmed positive and negative patients.MethodsThirty saliva samples of 10 saliva RT-PCR negative and 20 saliva RT-PCR positive patients were tested by RAT.ResultsRAT was negative in 10/10 (100%) RT-PCR-negative samples; positive in 9/20 (45%) RT-PCR-positive samples; concordance was 63% (p=0.001). Patients with positive RAT had higher virus copies in their NPS samples compared to the RAT-negative patients. This difference was also statistically significant (p=0.01).ConclusionThus, the POC RAT may be used to detect SARS-CoV2 as a reliable tool for self-testing, large-scale population screening and emergency medical/dental screening. Patients negative by RAT should be confirmed by RT-PCR.


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S388-S388
Author(s):  
Nitika Pant Pai ◽  
Ali Esmail ◽  
Gayatri Marathe ◽  
Suzette Oelofse ◽  
Marietjie Pretorius ◽  
...  

Abstract Background HIV self-testing (HIVST) offers a potential for expanded test access; challenges remain in operationalizing rapid personalized linkages and referrals to care. We investigated if an app-optimized personalized HIVST strategy improved referrals, detected new infections and expedited linkages to care and treatment. Methods In an ongoing cohort study (n = 2,000) based in South Africa, from November 2016 to January 2018, to participants presenting to self-test at community township based clinics, we offered a choice of the following strategies: (a) unsupervised HIVST; (b) supervised HIVST. We also observed participants opting for conventional HIV testing (ConvHT) in geographically separated clinics. We observed outcomes (i.e., linkage initiation, referrals, disease detection) and compared it between the two (HIVST vs. ConvHT) for the same duration. Results Of 2,000 participants, 1,000 participants were on HIVST, 599 (59.9%) chose unsupervised HIVST, 401 (40.1%) on supervised HIVST; compared with 1,000 participants on ConvHT. Participants in HIVST vs. ConvHT were comparable young (mean age 27.7 [SD = 9.0] vs. 29.5 [SD = 8.4]); female (64.0% vs. 74.7%); poor monthly income <3,000 RAND ($253 USD) (79.9% vs. 76.4%). With HIV ST (vs. ConvHT), many more referrals (17.4% [15.1–19.9] vs. 2.6% [1.7–3.8]; RR 6.69 [95% CI: 4.47–10.01]), and many new infections (86 (8.6% (6.9–10.5)) vs. 57 (5.7% (4.3–7.3)); Odds Ratio 1.55 [95% CI 1.1–2.2]) were noted. Break up: 45 infections in supervised HIVST 45 (52.3%); 41 infections in unsupervised HIVST (47.6%)]. Preference for HIVST was at 91.6%. With an app-optimized HIVST strategy, linkages to care were operationalized within a day in all participants (99.7% (HIVST) vs. 99.2% (ConvHT); RR 1.005 [95% CI: 0.99–1.01]); 99.8% supervised HIVST, 99.7% unsupervised HIVST. Conclusion Our app-optimized HIVST strategy successfully increased test referrals, detected new infections, and operationalized linkages within a day. This innovative, patient preferred strategy holds promise for a global scale up in digitally literate populations worldwide. Disclosures All authors: No reported disclosures.


2020 ◽  
Vol 31 (14) ◽  
pp. 1364-1372
Author(s):  
Yu-Hsiang Hsieh ◽  
Mitra K Lewis ◽  
Valentina G Viertel ◽  
Deanna Myer ◽  
Richard E Rothman ◽  
...  

We evaluated the accuracy and perception of a patient self-administered, tablet-facilitated rapid Trichomonas vaginalis (TV) point-of-care (POC) test in adult female emergency department (ED) patients. ED patients undergoing gynecologic examination were eligible. Each consented participant self-collected a vaginal swab, performed a tablet-facilitated TV rapid test using the OSOM® Trichomonas Rapid Test, and completed pre- and post-test self-surveys. After the self-test, the clinician collected one standard-of-care (SOC) vaginal swab for wet-mount testing and two for research. The research coordinator performed the TV rapid test using the clinician-collected swab, and reported the results to the clinician and patient. If the self- and coordinator-performed results were discordant, a TV nucleic acid amplification test (NAAT) was performed in a clinical laboratory. A survey was later administered to providers to assess their perceptions of the utility of the POC TV test. Of the 136 participants, 134 (98.5%) completed self-testing; two had invalid results. Comparing coordinator-performed TV rapid test adjudicated with NAAT, the sensitivity and specificity of self-administered test was 96.0% and 100%, respectively. The wet mount had a sensitivity of 52.0% and specificity of 100%. TV detection increased from 9.6% with wet mount to 18.4% with the TV rapid test. Most women (82.0%) stated self-testing was “not at all hard” (versus 66.2% before testing, p < 0.001). Clinicians indicated the TV rapid test affected their clinical management in 48.5% of cases, including 82.6% of positive cases and 41.6% of negative cases. ED patients were able to reliably collect, perform, and interpret their own POC TV test using tablet instructions. Both participants and providers reported high levels of acceptability of POC TV testing, which nearly doubled rates of TV detection.


Author(s):  
Dan Wu ◽  
Yi Zhou ◽  
Nancy Yang ◽  
Shanzi Huang ◽  
Xi He ◽  
...  

Abstract Background Social media and secondary distribution (distributing self-testing kits by indexes through their networks) both show strong promise to improve human immunodeficiency virus (HIV) self-testing uptake. We assessed an implementation program in Zhuhai, China, which focused on the secondary distribution of HIV/syphilis self-test kits among men who have sex with men (MSM) via social media. Methods Men aged ≥16 years, born biologically male, and ever had sex with another man were recruited as indexes. Banner ads on a social media platform invited the participants to apply for up to 5 self-test kits every 3 months. Index men paid a deposit of US$15/kit refundable upon submitting a photograph of a completed test result via an online submission system. They were informed that they could distribute the kits to others (referred to as “alters”). Results A total of 371 unique index men applied for 1150 kits (mean age, 28.7 [standard deviation, 6.9] years), of which 1141 test results were returned (99%). Among them, 1099 were valid test results; 810 (74%) were from 331 unique index men, and 289 tests (26%) were from 281 unique alters. Compared to index men, a higher proportion of alters were naive HIV testers (40% vs 21%; P &lt; .001). The total HIV self-test reactivity rate was 3%, with alters having a significantly higher rate than indexes (5% vs 2%; P = .008). A total of 21 people (3%) had a reactive syphilis test result. Conclusions Integrating social media with the secondary distribution of self-test kits may hold promise to increase HIV/syphilis testing coverage and case identification among MSM.


2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Nitika Pant Pai ◽  
Madhavi Bhargava ◽  
Lawrence Joseph ◽  
Jigyasa Sharma ◽  
Sabrina Pillay ◽  
...  

Background.A convenient, private, and accessible HIV self-testing strategy stands to complement facility-based conventional testing. Over-the-counter oral HIV self-tests are approved and available in the United States, but not yet in Canada. Canadian data on self-testing is nonexistent. We investigated the feasibility of offering an unsupervised self-testing strategy to Canadian students.Methods.Between September 2011 and May 2012, we recruited 145 students from a student health clinic of a large Canadian university. Feasibility of operationalization (i.e., self-test conduct, acceptability, convenience, and willingness to pay) was evaluated. Self-test conduct was computed with agreement between the self-test performed by the student and the test repeated by a healthcare professional. Other metrics were measured on a survey.Results.Participants were young (median age: 22 years), unmarried (97%), and 47% were out of province or international students. Approximately 52% self-reported a history of unprotected casual sex and sex with multiple partners. Self-test conduct agreement was high (100%), so were acceptability (81%), convenience (99%), and willingness to pay (74%) for self-tests. Concerns included accuracy of self-tests and availability of expedited linkages.Conclusion.An unsupervised self-testing strategy was found to be feasible in Canadian students. Findings call for studies in at-risk populations to inform Canadian policy.


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