scholarly journals SafeSwab, a sample collection and dispensing device for near-patient testing

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

2016 ◽  
Vol 10 (2) ◽  
pp. 18-21
Author(s):  
Noor Jahan ◽  
Tabassum Ghani ◽  
Afrina Begum ◽  
Taufiqua Hussain ◽  
Sahada Anwar

Vaginitis is the most frequent gynaecologic diagnosis encountered by physician providing primary care to the women. It is defined as inflammation and/or irritation of the vagina, a troublesome condition that affects millions of women in all parts of the world. A total of 50 women of reproductive age within 15-45 years, both pregnant and non-pregnant with abnormal vaginal discharge were enrolled in the study. Vaginal fluid was collected from the patients attending outpatient department of Dhaka Medical College & Hospital. A rapid vaginal immunochromatography kit were used to test the samples for Chlamydia, Trichomonas, Candida and Gardnerellavaginalis along with pH, nitrites, protein and leucocytes. Bacterial vaginitis was diagnosed in 16%, 20% and 18% of the cases using microscopy, culture and rapid vaginal test kit respectively, whereas, was detected in 16%, 8%, 16% by microscopy, culture and rapid vaginal kit respectively in case of bacterial vaginosis. Chlamydia(6.66%) and Trichomonas (6.66%) was detected in the vaginal kit and Candida was detected in 3.33% cases using all three methods. Rapid vaginal kit is a simple, rapid test (result within 10 minutes) and can be used as a point of care test or for screening large number of samples. Bangladesh J Med Microbiol 2016; 10 (2): 18-21


2018 ◽  
Vol 14 (3) ◽  
pp. 229-240
Author(s):  
Johanna Lindell

As antibiotic resistance becomes a growing health emergency, effective strategies are needed to reduce inappropriate antibiotic use. In this article, one such strategy – communicative practices associated with the C-reactive protein point-of care test – is investigated. Building on a collection of 31 videorecorded consultations from Danish primary care, and using conversation analysis, this study finds that the rapid test can be used throughout the consultation to incrementally build the case for a nonantibiotic treatment recommendation, both when the test result is forecast and reported. The study also finds that the format of reports of elevated results differs from that of ‘normal’ results, resulting in a subtle shift of authority from doctor to test.


2021 ◽  
pp. 003335492110458
Author(s):  
Ethan M. Berke ◽  
Lori M. Newman ◽  
Suzanna Jemsby ◽  
Bethany Hyde ◽  
Natasha Bhalla ◽  
...  

The COVID-19 pandemic prompted widespread closures of primary and secondary schools. Routine testing of asymptomatic students and staff members, as part of a comprehensive mitigation program, can help schools open safely. “Pooling in a pod” is a public health surveillance strategy whereby testing cohorts (pods) are based on social relationships and physical proximity. Pooled testing provides a single laboratory test result for the entire pod, rather than a separate result for each person in the pod. During the 2020-2021 school year, an independent preschool–grade 12 school in Washington, DC, used pooling in a pod for weekly on-site point-of-care testing of all staff members and students. Staff members and older students self-collected anterior nares samples, and trained staff members collected samples from younger students. Overall, 12 885 samples were tested in 1737 pools for 863 students and 264 staff members from November 30, 2020, through April 30, 2021. The average pool size was 7.4 people. The average time from sample collection to pool test result was 40 minutes. The direct testing cost per person per week was $24.24, including swabs. During the study period, 4 surveillance test pools received positive test results for COVID-19. A post-launch survey found most parents (90.3%), students (93.4%), and staff members (98.8%) were willing to participate in pooled testing with confirmatory tests for pool members who received a positive test result. The proportion of students in remote learning decreased by 62.2% for students in grades 6-12 ( P < .001) and by 92.4% for students in preschool to grade 5 after program initiation ( P < .001). Pooling in a pod is a feasible, cost-effective surveillance strategy that may facilitate safe, sustainable, in-person schooling during a pandemic.


2021 ◽  
Author(s):  
Bilgin Osmanodja ◽  
Klemens Budde ◽  
Daniel Zickler ◽  
Marcel G. Naik ◽  
Jörg Hofmann ◽  
...  

AbstractBackgroundAntigen-detecting rapid diagnostic tests (Ag-RDT) for SARS-CoV-2 offer new opportunities for the quick and laboratory-independent identification of infected individuals for control of the SARS-CoV-2 pandemic. Despite the potential benefits, nasopharyngeal sample collection is frequently perceived as uncomfortable by patients and requires trained healthcare personnel with protective equipment. Therefore, anterior nasal self-sampling is increasingly recognized as a valuable alternative.MethodsWe performed a prospective, single-center, point of care validation of an Ag-RDT using a polypropylene absorbent collector for standardized self-collected anterior nasal swabs. Real-Time Polymerase Chain Reaction (RT-PCR) from combined oropharyngeal/nasopharyngeal swabs served as a comparator. Primary endpoint was sensitivity of the standardized Ag-RDT in symptomatic patients with medium or high viral concentration (≥ 1 million RNA copies on RT-PCR for SARS-CoV-2).ResultsBetween February 12 and March 22, 2021, 388 participants were enrolled. After exclusion of 9 patients for which no PCR result could be obtained, the novel Ag-RDT was evaluated based on 379 participants, of which 273 were symptomatic and 106 asymptomatic. In 61 samples from symptomatic patients with medium or high viral load (≥ 1 million RNA copies), the sensitivity of the standardized Ag-RDT was 96.7% (59/61; 95%CI: 88.7-99.6%) for the primary endpoint. In total, 62 positive Ag-RDT results were detected out of 70 RT-PCR positive individuals, yielding an overall sensitivity of 88.6% (95%CI: 78.7-94.9%). Specificity was 99.7% (95%CI: 98.2-100%) in 309 RT-PCR negative individuals.ConclusionHere, we present a validation of a novel Ag-RDT with a standardized sampling process for anterior nasal self-collection, which meets WHO criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, this assay could be beneficial due to its rapid results, ease of use, and suitability for standardized self-testing.(Funded by Drägerwerk AG & Co. KGaA, Lübeck, Germany; ClinicalTrials.gov number NCT04698993)


Author(s):  
Akinfemi Oyewumi Akinyode ◽  
Ikeoluwapo Ajayi ◽  
Muhammed Ibrahim ◽  
Joshua Akinyemi ◽  
Olufemi Ajumobi

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.


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.


2021 ◽  
Author(s):  
Marie Hagbom ◽  
Noelia Carmona-Vicente ◽  
Sumit Sharma ◽  
Henrik Olsson ◽  
Mikael Jamtberg ◽  
...  

Background: The COVID-19 pandemic has highlighted the need for rapid, cost effective and easy-to-use diagnostic tools for SARS-CoV-2 rapid antigen detection (RAD) for use in point of care settings or as self-tests, to limit disease transmission. Using saliva samples would further greatly facilitate sample collection, diagnostic feasibility, and mass screening. Objective: We tested two rapid antigen immunochromatographic tests designed for detection of SARS-CoV-2 in saliva: Rapid Response COVID-19 Antigen Rapid Test Cassette for oral fluids (Rapid Response) and DIAGNOS COVID-19 Antigen Saliva Test (DIAGNOS). Evaluation of detection limit was performed with purified SARS-CoV-2 nucleocapsid protein and titrated live SARS-CoV-2 virus and compared to Abbott Panbio COVID-19 Ag Rapid Test (Panbio) designed for nasopharyngeal samples. Sensitivity and specificity were further evaluated on RT-qPCR positive and negative saliva samples from individuals hospitalized with COVID-19 (n=34); and asymptomatic health care personnel (n=20). Results: The limit of detection of the saliva test from DIAGNOS was comparable with the Panbio test and showed higher sensitivity than Rapid Response for both nucleocapsid protein and diluted live viruses. DIAGNOS and Rapid Response further detected seven (47%) and five (33%), respectively, of the 15 RT-qPCR positive saliva samples in individuals hospitalized with COVID-19. Of the 39 RT-qPCR negative samples, all were negative with both tests (specificity 100%; 95% c.i. 0.91-1.00). Only one of the RT-qPCR positive saliva samples (Ct 21.6) contained infectious virus as determined by cell culture and was also positive using the saliva RADs. Conclusion: The results show that the DIAGNOS test exhibit a similar limit of detection as the Panbio RAD and may be an important and easy-to-use saliva RAD complement to detect infectious individuals.


2020 ◽  
Author(s):  
Gill Kazevman ◽  
Marck Mercado ◽  
Jennifer Hulme ◽  
Andrea Somers

UNSTRUCTURED Vulnerable populations have been identified as having higher infection rates and poorer COVID-19 related outcomes, likely due to their inability to readily access primary care, follow public health directives and adhere to self-isolation guidelines. As a response to the COVID-19 pandemic, many health care services have adopted new digital solutions, relying on phone and internet connectivity. Yet, persons who are digitally inaccessible, such as those struggling with poverty or homelessness, are often unable to utilize these services. In response to this newly highlighted social disparity known as “digital health inequity”, emergency physicians at the University Health Network, Toronto, initiated a program called “PHONE CONNECT”. This novel approach attempts to improve patients’ access to health care, information and social services, as well as improve their ability to adhere to public health directives (social isolation and contact tracing). While similar programs addressing the same emerging issues have been recently described in the media, this is the first time phones are provided as a health care intervention in an emergency department. This innovative ED point-of-care intervention may have a significant impact on improving the health outcomes for vulnerable people during the COVID-19 pandemic, and even beyond it.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Danielle M. Nash ◽  
Zohra Bhimani ◽  
Jennifer Rayner ◽  
Merrick Zwarenstein

Abstract Background Learning health systems have been gaining traction over the past decade. The purpose of this study was to understand the spread of learning health systems in primary care, including where they have been implemented, how they are operating, and potential challenges and solutions. Methods We completed a scoping review by systematically searching OVID Medline®, Embase®, IEEE Xplore®, and reviewing specific journals from 2007 to 2020. We also completed a Google search to identify gray literature. Results We reviewed 1924 articles through our database search and 51 articles from other sources, from which we identified 21 unique learning health systems based on 62 data sources. Only one of these learning health systems was implemented exclusively in a primary care setting, where all others were integrated health systems or networks that also included other care settings. Eighteen of the 21 were in the United States. Examples of how these learning health systems were being used included real-time clinical surveillance, quality improvement initiatives, pragmatic trials at the point of care, and decision support. Many challenges and potential solutions were identified regarding data, sustainability, promoting a learning culture, prioritization processes, involvement of community, and balancing quality improvement versus research. Conclusions We identified 21 learning health systems, which all appear at an early stage of development, and only one was primary care only. We summarized and provided examples of integrated health systems and data networks that can be considered early models in the growing global movement to advance learning health systems in primary care.


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