Home Testing Research Articles

A Multi-Channel Handheld Diagnostic Device Based on Green Biomimetic Material for Point-of-Care Testing of Vitamin C in Human Fluids.

In the era of "Great Health", maintaining an appropriate level of vitamin C is crucial for human health as it directly impacts the proper functioning of the immune system. In this study, a handheld nonenzymatic electrochemical sensor based on biomimetic material prussian blue functionalized polydopamine is proposed for point-of-care testing (POCT) of vitamin C in human fluids. Particularly, Prussian blue, known as a bio-antidote, and polydopamine, a main component of cuttlefish ink, ensure the safety and reliability of home testing. The experimental results quantitatively demonstrate that this electrochemical POCT sensor enables rapid and accurate determination of vitamin C with a wide linear detection range from 0.2 to 200µm, a low limit of detection at 0.03µm, and high sensitivity at 0.33µAµm-1cm-2. More importantly, the performance evaluation using human urine and saliva samples confirms satisfactory accuracy and recovery rates for vitamin C determination by this electrochemical POCT sensor. Thus, the proposed handheld electrochemical POCT sensor holds potential utility as an affordable tool for VC determination and home-based healthcare.

Advice from a Doctor or AI? Understanding Willingness to Disclose Information Through Remote Patient Monitoring to Receive Health Advice

Remote Patient Monitoring (RPM) devices transmit patients' medical indicators (e.g., blood pressure) from the patient's home testing equipment to their healthcare providers, in order to monitor chronic conditions such as hypertension. AI systems have the potential to enhance access to timely medical advice based on the data that RPM devices produce. In this paper, we report on three studies investigating how the severity of users' medical condition (normal vs. high blood pressure), security risk (low vs. modest vs. high risk), and medical advice source (human doctor vs. AI) influence user perceptions of advisor trustworthiness and willingness to disclose RPM-acquired information. We found that trust mediated the relationship between the advice source and users' willingness to disclose health information: users trust doctors more than AI and are more willing to disclose their RPM-acquired health information to a more trusted advice source. However, we unexpectedly discovered that conditional on trust, users disclose RPM-acquired information more readily to AI than to doctors. We observed that the advice source did not influence perceptions of security and privacy risks. We conclude by discussing how our findings can support the design of RPM applications.

Does testing environment matter for virtual school students?

Standardized test performance among students in full-time virtual schools generally lags behind that of students in traditional, face-to-face schools. One largely unexplored potential cause is the requirement to complete tests at unfamiliar facilities rather than from home, the normal learning environment for these students. The COVID-19 pandemic enabled some full-time virtual school students to test from home, providing a unique opportunity to assess how testing environment might influence outcomes. Using data from an educational management organization (EMO) running virtual schools in 21 U.S. states, we test whether full-time virtual school students perform better on standardized exams administered at home (n=524) relative to those testing at an unfamiliar testing site (n=1,443) in 2020-21. Home testing is associated with nearly one fifth of a standard deviation improvement in math and ELA performance even after controlling for prior test performance. Moreover, tests taken from home more strongly correlate with other measures of academic performance than do tests taken at designated facilities, indicating they better capture academic progress. Analyses investigating whether home testing enables cheating are inconclusive.

Assess the knowledge regarding food adulteration among house wife: A study on berhampur city of Ganjam district, Odisha

Adulteration of food has occurred if it contains any substance injurious to health; it contains any filthy, putrid or decomposed substance; it is prepared, handled or stored under unsanitary conditions; diseased animals have been used in preparation; the container is made of a poisonous substance which will render the contents harmful; contains colours and preservatives other than those permitted by law; it contains pesticide residues or additives not recognised as safe etc. foods may be adulterated either intentional or incidental at all stages from production to selling. Food is adulterated if its quality is lowered or affected by the addition of substances which are injurious to health or by the removal of substances which are nutritious. The present study focuses on the awareness of the housewives among the consumers on food adulterants and to find out the extent of adulteration of the food stuffs. This study was conducted to assess the knowledge about food adulteration among 100 housewives in selected areas, Berhampur. A survey was conducted to collect the information through interview method. They must be well acquainted with the physical food characteristics such as appearance, colour, shape, texture, touch, flavour, taste etc. The urban and rural women are using the home test method for detecting food adulteration. Some urban house wives are having knowledge about food law and the rest of the housewife’s are not aware about food law. The rural housewife’s are not having any knowledge regarding food law, food standard and consumer protection Act. It can be concluded that some women are not having any knowledge regarding different adulteration programme. So, the government and people should promote the different adulteration programme. The media should take a great role to aware women in an interesting and attractive manner. Hence, it is essential to create community awareness and take interventional measures for the health and wellbeing of the community

Community case study for surveillance and early case-detection of SARS-CoV-2 infections across high-risk key populations: the Sentinella programme.

At the beginning of the COVID-19 pandemic, an ad hoc organisational framework was established between academic, local government and community partners to implement the "Sentinella - Identify, Trace and Prevent" screening programme in Verona, north-east Italy. Between September 2020 and May 2021, key populations not covered by any screening policies at the local and national level were screened for SARS-CoV-2. Target populations were: older adult residents (males >65 years and females >75 years), bus and taxi drivers, social workers, supermarket employees, hospital cleaning and catering staff, researchers working in the local hospitals, students, and people experiencing homelessness (PEH). Five dedicated swab clinics, home testing facilities, and one mobile clinic were activated to collect nasopharyngeal swabs. Molecular analysis was performed for all the subjects; an antigen-rapid diagnostic test (Ag-RDT) was also implemented as a point-of-care test for PEH. Medical follow-up, psychological support, and quarantine facilities were organised for subjects who tested positive for SARS-CoV-2. Overall, 2075 subjects participated in the surveillance programme. Amongst these, 1,572 were residents/workers, whilst 503 were PEH. A total of 127 (6.2%) participants tested positive for SARS-CoV-2. Sixty-nine were residents, 58 PEH. The incidence rate was 4 per 10.000 person/day (95% CI 3.1-5.0). The highest prevalence and incidence rates were found amongst supermarket employees (9.7% and 8.5 per 10.000 person/day, 95% CI 3.81-18.86, respectively), followed by hospital cleaning staff (8.1%, 7.6 per 10.000 person/day, CI 95% 4.9-11.7). Regarding PEH, the prevalence of SARS-CoV-2 was 11.5%. All PEH identified as positive were isolated in dedicated shelter facilities. Amongst the 69 residents/workers who were quarantined, 53 were reached for initial psychological support for assessing the presence of any psychological distress or psychiatric pathology. Amongst the subjects evaluated, 10 (18.9%) presented clinically significant psychological discomfort and accessed the stepped-care psychological intervention. The community partnerships played a pivotal role in optimising early case detection. Promotion of testing helped to prevent and contain more efficiently potential clusters through strategic planning, especially for PEH. Insights from the study highlight the importance of community partnerships in public health emergencies, particularly in the context of highly transmissible diseases pathways.

A novel double-door-opening sensor for visual determination of cardiac troponin I based on DNA hydrogel and bimetallic nanozyme

Cardiac troponin I (cTnI), as a cardiac biomarker, holds significant importance in the diagnosis of acute myocardial infarction. However, the current detection methods mostly require specialized personnel and large analytical instruments, making it difficult to achieve convenient and on-site testing. This situation leads to delayed disease diagnosis and treatment, that increases patient suffering, and reduces the cure rate. This strategy presents the development of a portable visual DNA hydrogel colorimetric sensing platform based on a smartphone. Utilizing dual-mode detection with ultraviolet signals and solution colorimetry, the platform achieves ultra-sensitive and real-time detection of cTnI. Furthermore, optimization of detection conditions, such as the amount of polyacrylamide, reaction time, aptamer concentration, encapsulation of the nanozyme, incubation time, and reaction temperature, were performed based on this platform. The proposed ultraviolet and visual detection platforms exhibited good linear relationships with the signal within the ranges of 0.003 ng mL−1 to 10.00 ng mL−1 and 0.01 ng mL−1 to 7.00 ng mL−1, with detection limits of 2.57 pg mL−1 and 0.013 pg mL−1, respectively. Additionally, utilizing 3D printing technology, a portable detection device was designed and employed for the detection of cTnI concentrations in human serum samples. Whatever in the initial and spiked samples, the results showed high sensitivities. The sensitivity and convenience of the sensor in detecting cTnI make it promising for home testing of patients, with broad market prospects.

Post-Vasectomy Semen Analysis: What's All the Fuss about?

Vasectomy is a reliable male contraceptive method with a success rate exceeding 98%. Despite its efficacy, vasectomy is not foolproof, with potential early and late failures requiring careful postoperative monitoring via post-vasectomy semen analysis (PVSA). Published guidelines emphasize the necessity of conducting PVSA to ensure clinical sterility. Despite these clear guidelines, discrepancies in adherence and interpretation persist, with significant mismatches between guidelines and actual practice. Recent shifts in societal attitudes toward reproductive autonomy, spurred by significant political events and socioeconomic factors, have increased vasectomy rates, particularly among younger, childless men. This demographic change calls for enhanced PVSA compliance and clear communication about the non-immediate contraceptive effect of vasectomy. Home test kits have emerged as a convenient, though not always reliable, method for conducting PVSAs, which may require reevaluation in clinical practice. Given the variations across clinical guidelines and the challenges in achieving consistent PVSA outcomes, further research is needed to harmonize PVSA protocols across different health systems. PVSA is typically conducted between 8 and 16 weeks post-vasectomy, depending on the surgeon's preference. Success is confirmed when a fresh, uncentrifuged sample exhibits either azoospermia, rare non-motile sperm (RNMS), or fewer than 100,000 non-motile sperm per milliliter. This effort will ensure that both patients and practitioners can rely on vasectomy as a safe and effective form of contraception. Effective patient counseling and strategic follow-up are crucial when it comes to managing expectations and ensuring compliance with post-vasectomy protocols, thereby minimizing the risk of unintended pregnancies post-procedure.

A-240 Validation of the OSOM Flu SARS-CoV-2 Combo Home Test

Abstract Background COVID-19 and Influenza respiratory infections often cause similar symptoms, however, treatment is different for each infection. Delay in diagnosis can be fatal in some cases, therefore rapid detection and differentiation are critical for appropriate medical treatment. The OSOM Flu SARS-CoV-2 Combo Home Test is a lateral flow immunoassay intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2 and influenza A/B proteins using self-collected anterior nasal swab samples (self-collection is only recommended for those 14 years of age and older). An interpretation card, included with the test, is used to reliably distinguish among possible testing results. Methods A prospective study was conducted at multiple geographically distinct sites in the U.S during the 2023-2024 season for the validation of the OSOM Flu SARS-CoV-2 Combo Home Test to detect SARS-CoV-2/Flu A/Flu B in self-collected anterior nasal swab samples. The study evaluated the performance in symptomatic individuals only. A total of 703 prospective samples were evaluable for SARS. For Flu A/B, four additional subject samples were unevaluable due to comparator results not being available and a total of 699 samples were included in the data analysis. The comparator tests were FDA 510(k)-cleared molecular assays. Results Influenza A was detected with a sensitivity of 93.1% (95% CI: 84.8%-97.0%) and a specificity of 99.5% (95% CI: 98.6% - 99.8%). Influenza B was detected with a sensitivity of 89.1% (95% CI: 77.0% - 95.3%) and a specificity of 99.7% (95% CI: 98.9% - 99.9%). SARS CoV-2 was detected with a sensitivity of 87.0% (95% CI 78.6% - 92.4%) and a specificity of 99.1% (95% CI: 97.9% - 99.6%) when Ct values are standardized and 10% of samples are considered low positives, having a Ct value of ≥ 30. Conclusions With respiratory infections often showing indistinguishable symptoms and the possibility of co infection, lowering the testing hurdles for individuals to be able to perform a rapid differential test at home without the aid from a healthcare worker is the most effective way to mitigate spread and patient management from a public health perspective. Comparing the OSOM Flu SARS-CoV-2 Combo Home test to the FDA cleared comparators in a clinical setting, the OSOM Flu SARS-CoV-2 Combo Home test retains acceptable sensitivity and specificity. Using self-collected anterior nasal swabs which are minimally invasive alongside the low cost of a lateral flow immunochromatographic assay remains the most effective way to perform the serial screening testing recommended by the CDC in situations where transmission and severe outcome risk is high.

A-327 Statistical Technique-based Image Analysis for Digital Reading of Immunochemistry Cassette

Abstract Background Covid-19 transformed healthcare and how we think about clinical diagnostics. People prefer at home testing options that enable them to focus on staying healthy at their own comfort and privacy. Fast and accurate lateral flow assays or rapid diagnostic test (RDT) meets that need, however ensuring high test specificity and accuracy are of utmost importance. Visual readout of RDTs is subjective and time consuming. With the current technological advancement, medical devices are smarter and can be used for automated readout. The core of such devices are the algorithms that process the information despite several limitations and unknown variations affecting input signals. Many such algorithms are developed and are used for similar applications. Here, a statistical model for any optical device that is designed to automatically read an RDT with one or more test lines is described. Methods The described LFA algorithm is a innovative way to analyze images acquired with Complementary Metal-Oxide-Semiconductor (CMOS) based optical system with low Signal-to-noise ratio (SNR), giving a semi quantitative result. This also takes care of variations in illumination sources with relatively reduced computation, by converting the images to a 1 Dimensional (1D) signal. Algorithm workflow: Image pre-processing: Affine transformations such as rotation, translation, etc. (depends on the inherent setup) are applied on the acquired images as a pre-processing step. Pattern matching techniques using Gaussian templates are applied to determine the window region of the LFA and precisely identify the test and control line regions. Image formatting: The sample region of the cassette is converted from RGB color space to the weighted gray (Gw) for digital interpretation of the primary biomarker present. Characterization of the Gw channel enables test peak detection with enhanced resolution. This helps in early call out of results and improved accuracy, thereby reducing chances of erroneous results. A second order Butterworth low pass filter is applied to reduce system noise and enhance SNR. The images are converted to 1D signal by averaging for mathematical read out. Mathematical interpretation: Maximum peak height (max) and minimum peak depth (min) of Gw channel values in the test line region (t-peak) are extracted from the 1D signal. The mathematical representation of the test line is calculated as: Test Peak Signal = {max(t-peak) - min(t-peak)} / Alpha; Normalization Factor, Alpha = (sum of all Gw channel values for any clear non-reactive part of the test device) / (number of Gw channel values) Results TPS values for various biomarkers from statistically significant replicates were computed at Low, Medium, and High levels. Two sample T-tests were performed, and respective p values are distinctly different as p-value<0.05. For a concentration level of Low to medium, p-value is 0.044 and for Medium - High p-value is 0.004. Conclusions This algorithm can run on any off-the-shelf available RDT coupled with a CMOS based optical system. The proposed algorithm can differentiate between low, medium, and high concentrations with high confidence. High throughput semiquantitative digital readouts are robust, accurate and are preferred for diagnostic test result interpretation.

Predicting mucosal inflammation in IBD patients using patient-reported symptom scores and a faecal calprotectin home test: protocol for a multicentre prospective validation study

IntroductionCrohn’s disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD) with a relapsing-remitting nature. With adequate non-invasive prediction of mucosal inflammation, endoscopies can be prevented and treatment optimised earlier...

Lessons from Covid-19 and the potential benefit of the implementation of Axon’s personal electronic health records (PEHR) into aesthetic care, plastic and reconstructive surgery

BackgroundCovid-19 pandemic highlighted the need for implementing Personal Electronic Health Records (PEHR) for patients’ data management. Furthermore, this pandemic underscored the relevance for integrated and interoperable Electronic Health Records (EHR) to support disease surveillance, hospital capacity planning and resource management (Peek N, Sujan M, Scott P (2020) Digital health and care in pandemic times: impact of COVID-19. BMJ Health Care Inf 27(1):e100166. https://doi.org/10.1136/bmjhci-2020-100166). Due to the lack of comprehensive patients’ record in plastic, reconstructive and aesthetic surgery, Axon’s myHealth app offers a break-through patient-centric design allowing patients to be in control of their records and updating them in real-time for their plastic and aesthetic care providers to have a clearer understanding of patients’ history and progress from pre-op to post-op.MethodsThe Axon Dublin survey took place during Covid-19 pandemic in two phases: Phase 1 aimed to assess the feasibility of patients integrating the Axon myHealth application into their clinical visits. Testing occurred in a clinical environment, where patients were encouraged to download and use the Axon system with a health practitioner (HP) present. Phase 2 focused on home testing, evaluating patients’ willingness to manage their health remotely with HP assistance. This phase included self-testing activities such as performing rapid Covid-19 antigen tests, recording medical history, and measuring blood pressure at home.ResultsThe Axon Dublin Study aimed to assess patient engagement, clinical impact, and cost-effectiveness of the Axon myHealth application. Over 85% of patients showed interest in owning a Personal Electronic Health Record. Notably, 36% continuously monitored chronic conditions. Clinical decisions, informed by patient data, saw 61.9% compliance. Noteworthy, 23% of hypertensive participants required immediate medication changes. Patient self-capture of data reduced consultation time. Public health implications were significant, with 39% vaccinated and 31% reporting complications. High user satisfaction (97%) demonstrated the app’s effectiveness in infection control and chronic care.ConclusionsOffering patients the ability to update and control their data is a growing interest, with a clear need in plastic and aesthetic surgery to have a better understanding of a patient’s medical past and progress throughout the surgical process and period. This platform, which is time and cost efficient, can only facilitate personalised care and improve outcomes while maintaining patient’s confidentiality.Level of evidenceNot gradable.

Abstract A142: A qualitative assessment of the acceptability of Human Papillomavirus (HPV) self-sampling and informational materials among diverse populations

Abstract Background: Disparities in cervical cancer screening rates among marginalized groups is a driver of inequalities in cervical cancer. Self-sampling for human papillomavirus (HPV) testing is a newly emerging alternative to clinician-performed testing to screen for cervical cancer, and has high potential to reduce screening barriers in under-screened and marginalized groups. We study the acceptability in of HPV self-sampling and informational materials among Black/African American, Hispanic/Spanish speaking, American Indian/Alaska Native and transgender/nonbinary populations. Methods: We conducted qualitative interviews with patients, ages 30-65, who were female at birth, Black/African American, Hispanic, American Indian, and/or transgender/nonbinary. Telephone interviews were conducted in English or Spanish. Patients did not complete the test, rather were asked about the attractiveness, comprehensibility, and acceptability of the HPV self-test, instructions, and messaging. Results: Among 23 completed interviews (5 American Indian/Alaska Native, 7 Hispanic (2 bilingual, 5 Spanish-speaking), 5 Black/African American, and 6 transgender/nonbinary), patients from all groups thought the test was straightforward and convenient, and they would complete the test at home or in clinic. The transgender/nonbinary patients preferred at home testing. American Indian and transgender/nonbinary patients liked that the test might avoid pain, discomfort, and invasiveness. All patients liked the letter and instructions. All groups had specific suggestions for making the materials more culturally acceptable. Conclusions: The HPV self-test and the instructions and materials for use were acceptable for a diverse group of patients. Tailored outreach and messaging should be considered to reduce screening disparities among groups that have been historically underserved by the medical system. Citation Format: Amanda Petrik, Jennifer Rivelli, Allison Firemark, Cheryl Johnson, Blake Locher, Sara Gille, Jennifer Schneider. A qualitative assessment of the acceptability of Human Papillomavirus (HPV) self-sampling and informational materials among diverse populations [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A142.

Summary of Varieties and Diversities of Nanomaterials Used in Food Safety and Quality

In all fields of life sciences, the trends toward sustainability, enhanced product safety, and high standards of quality are significant. The food industry uses intelligent packaging to meet these needs. These systems can continuously monitor a product's quality status and notify the customer of any changes. Conventional methods can only satisfy the needs of regular laboratory food analysis. Thus, in the cases of major food safety concerns, quick, economical, and time-saving analysis techniques, including portable, on-site, and home testing kits, are desperately needed. Nonetheless, there is a chance that nanoparticles could be harmful to people's health. Nanotechnology, for instance, can be applied to food processing to improve food's overall quality, including taste, flavor, and bioavailability. It can also help products last longer on the shelf. Moreover, nanotechnology is often applied to food packaging to deliver innovative packaging and serve as an antimicrobial agent. It can offer fresh approaches to thwart fraud and serve as a valuable weapon in our toolbox to prevent bioterrorism. As a result, it is advised to set up a sufficient regulatory framework to control any dangers related to applications of nanotechnology. This review addresses the classification and safety issues involved in the application of nanotechnology in food safety and packaging.

Evaluating the Effectiveness of Transtibial Prosthetic Socket Shape Design Using Artificial Intelligence: A Clinical Comparison With Traditional Plaster Cast Socket Designs

ObjectiveTo investigate the feasibility of creating an artificial intelligence (AI) algorithm to enhance prosthetic socket shapes for transtibial prostheses, aiming for a less operator-dependent, standardized approach. DesignThe study comprised 2 phases: first, developing an AI algorithm in a cross-sectional study to predict prosthetic socket shapes. Second, testing the AI-predicted digitally measured and standardized designed (DMSD) prosthetic socket against a manually measured and designed (MMD) prosthetic socket in a 2-week within-subject cross-sectional study. SettingThe study was done at the rehabilitation department of the Radboud University Medical Center in Nijmegen, the Netherlands. ParticipantsThe AI algorithm was developed using retrospective data from 116 patients from a Dutch orthopedic company, OIM Orthopedie, and tested on 10 randomly selected participants from Papenburg Orthopedie. InterventionsUtilization of an AI algorithm to enhance the shape of a transtibial prosthetic socket. Main Outcome MeasuresThe algorithm was optimized to minimize the error in the test set. Participants’ socket comfort score and fitting ratings from an independent physiotherapist and prosthetist were collected. ResultsPredicted prosthetic shapes deviated by 2.51 mm from the actual designs. In total, 8 of 10 DMSD and all 10 MMD-prosthetic sockets were satisfactory for home testing. Participants rated DMSD-prosthetic sockets at 7.1 ± 2.2 (n=8) and MMD-prosthetic sockets at 6.6 ± 1.2 (n=10) on average. ConclusionsThe study demonstrates promising results for using an AI algorithm in prosthetic socket design, but long-term effectiveness and refinement for improved comfort and fit in more deviant cases are necessary.

Home self-testing of complete blood counts in patients with breast cancer during chemotherapy: A proof-of-concept cohort study in e-oncology.

Before administration of myelosuppressive chemotherapy, complete blood counts (CBC) collected at the hospital/nursing stations are evaluated to avoid severe bone marrow suppression. This maintains disease fixation which often reduces their quality of life. This mixed-method study examined at home self-testing of CBC, the test quality, and the effects on patients' mental well-being. Patients with breast cancer receiving chemotherapy were recruited and trained to perform capillary finger prick CBC testing at home using the HemoScreen Point-of-Care instrument and to upload the test results to the hospital's IT system subsequently. A venous reference CBC sample was taken and tested at the hospital on the day of self-testing. Semi-structured interviews with open-ended components were performed to investigate the user experience and the impact of self-testing on the patients' everyday lives. Thirty-nine patients completed the self-testing education using the HemoScreen instrument. Eight patients withdrew, while the remaining 31 patients performed 161 home tests (2-11 tests per patient) over a 4-month period. The test results compared well with the venous reference CBCs except for platelet counts (correlation coefficient 0.26). Qualitative interviews with nine of the 31 patients emphasized that the patients were comfortable using the self-testing instrument and becoming an active partner in their own treatment. CBC self-testing at home produced clinically valid hemoglobin and white blood cell counts with the added benefit that the patients became active partners in their own treatment course, which was of great importance for the patients and increased their wellbeing.

Update on Patient Self-Testing with Portable and Wearable Devices: Advantages and Limitations.

Laboratory medicine has undergone a deep and multifaceted revolution in the course of human history, in both organizational and technical terms. Over the past century, there has been a growing recognition of the need to centralize numerous diagnostic activities, often similar or identical but located in different clinical departments, into a common environment (i.e., the medical laboratory service), followed by a progressive centralization of tests from smaller laboratories into larger diagnostic facilities. Nevertheless, the numerous technological advances that emerged at the beginning of the new millennium have helped to create a new testing culture characterized by a countervailing trend of decentralization of some tests closer to patients and caregivers. The forces that have driven this (centripetal) counter-revolution essentially include a few key concepts, namely "home testing", "portable or even wearable devices" and "remote patient monitoring". By their very nature, laboratory medical services and remote patient testing/monitoring are not contradictory, but may well coexist, with the choice of one or the other depending on the demographic and clinical characteristics of the patient, the type of analytical procedure and the logistics and local organization of the care system. Therefore, this article aims to provide a general overview of patient self-testing, with a particular focus on portable and wearable (including implantable) devices.

Abstract P337: Impact of a population health approach using smartphone-enabled home albuminuria testing to improve screening in patients with hypertension or diabetes

Background: Screening for albuminuria with urine albumin/creatinine ratio (ACR) testing among at risk patients is critical as guideline-based therapies can be used to decrease the risk of cardiovascular and kidney disease. However, adherence to testing remains very low, especially for hypertension. Here, we report the results from a prospective pilot study involving a smartphone-enabled home albuminuria testing quality improvement. Methods: We randomly selected 4000 adult individuals (50% with hypertension but no diabetes and 50% with diabetes +/- hypertension) receiving primary care at a large healthcare system in Central and Northeastern Pennsylvania who had not undergone ACR testing in the past 12 months to receive Minuteful Kidney, an FDA-cleared, smartphone-enabled home urine albuminuria screening kit using the vendor’s (Healthy.io) standard workflow. The home testing group was matched 1:1 to 4000 controls who received usual care using propensity score matching addressing imbalances in sociodemographics and comorbidities. The primary outcome was completion of ACR test (either laboratory based ACR or Minuteful Kidney) within 100 days of the index date. Results shown are as of May 1, 2024 (86 days after the index date). Results: Overall, completion of any ACR test was higher in the home testing group than matched controls (50.2% vs. 19.1%; p<0.001). The impact on ACR testing was higher for the hypertension subgroup (50.4% vs. 11.2%; p<0.001) than the diabetes subgroup (49.9% vs. 26.9%; p<0.001). Among the home testing group, 1542/4000 (38.7%) completed the smartphone ACR test, with a higher proportion of completions in non-diabetic hypertension (848/2000 [42.4%] than the diabetes subgroup (663/2000 [33.2%]). Adherence rates were similar across age groups and geographic location. Satisfaction was high among individuals in the home testing group (53+ Net Promoter Score; 94% rated the test as easy or very easy to complete; 88% stated preference for at home testing). Home-based albuminuria screening detected mild to moderate albuminuria (30-300 mg/g) in 33.2% and severe albuminuria (>300 mg/g) in 8.1%. Abnormal results were fairly similar for the diabetes subgroup (33.8% 30-300 mg/g, 10.8% >300 mg/g) and the hypertension subgroup (32.6% 30-300 mg/g, 5.9% >300 mg/g). Conclusions: A population health approach using smartphone-enabled home albuminuria testing is effective in increasing albuminuria screening among individuals with hypertension or diabetes.

An at-home and electro-free COVID-19 rapid test based on colorimetric RT-LAMP.

In the fight against virus-caused pandemics like COVID-19, diagnostic tests based on RT-qPCR are essential, but they are sometimes limited by their dependence on expensive, specialized equipment and skilled personnel. Consequently, an alternative nucleic acid detection technique that overcomes these restrictions, called loop-mediated isothermal amplification following reverse transcription (RT-LAMP), has been broadly investigated. Nevertheless, the developed RT-LAMP assays for SARS-CoV-2 detection still require laboratory devices and electrical power, limiting their widespread use as rapid home tests. This work developed a flexible RT-LAMP assay that gets beyond the drawbacks of the available isothermal LAMP-based SARS-CoV-2 detection, establishing a simple and effective at-home diagnostic tool for COVID-19. A multiplex direct RT-LAMP assay, modified from the previously developed test was applied to simultaneously identify the two genes of SARS-CoV-2. We used a colorimetric readout, lyophilized reagents, and benchmarked an electro-free and micropipette-free method that enables sensitive and specific detection of SARS-CoV-2 in home settings. Forty-one nasopharyngeal swab samples were tested using the developed home-testing RT-LAMP (HT-LAMP) assay, showing 100% agreement with the RT-qPCR results. This is the first electrically independent RT-LAMP assay successfully developed for SARS-CoV-2 detection in a home setting. Our HT-LAMP assay is thus an important development for diagnosing COVID-19 or any other infectious pandemic on a population scale.

VIVALDI ASCOT and Ethnography Study: protocol for a mixed-methods longitudinal study to evaluate the impact of COVID-19 and other respiratory infection outbreaks on care home residents’ quality of life and psychosocial well-being

IntroductionOlder adults in care homes experienced some of the highest rates of mortality from SARS-CoV-2 globally and were subjected to strict and lengthy non-pharmaceutical interventions, which severely impacted their daily...

Feasibility of wearable sensor signals and self-reported symptoms to prompt at-home testing for acute respiratory viruses in the USA (DETECT-AHEAD): a decentralised, randomised controlled trial

Early identification of an acute respiratory infection is important for reducing transmission and enabling earlier therapeutic intervention. We aimed to prospectively evaluate the feasibility of home-based diagnostic self-testing of viral pathogens in individuals prompted to do so on the basis of self-reported symptoms or individual changes in physiological parameters detected via a wearable sensor. DETECT-AHEAD was a prospective, decentralised, randomised controlled trial carried out in a subpopulation of an existing cohort (DETECT) of individuals enrolled in a digital-only observational study in the USA. Participants aged 18 years or older were randomly assigned (1:1:1) with a block randomisation scheme stratified by under-represented in biomedical research status. All participants were offered a wearable sensor (Fitbit Sense smartwatch). Participants in groups 1 and 2 received an at-home self-test kit (Alveo be.well) for two acute respiratory viral pathogens: SARS-CoV-2 and respiratory syncytial virus. Participants in group 1 could be alerted through the DETECT study app to take the at-home test on the basis of changes in their physiological data (as detected by our algorithm) or due to self-reported symptoms; those in group 2 were prompted via the app to self-test only due to symptoms. Group 3 served as the control group, without alerts or home testing capability. The primary endpoints, assessed on an intention-to-treat basis, were the number of acute respiratory infections presented (self-reported) and diagnosed (electronic health record), and the number of participants using at-home testing in groups 1 and 2. This trial is registered with ClinicalTrials.gov, NCT04336020. Between Sept 28 and Dec 30, 2021, 450 participants were recruited and randomly assigned to group 1 (n=149), group 2 (n=151), or group 3 (n=150). 179 (40%) participants were male, 264 (59%) were female, and seven (2%) identified as other. 232 (52%) were from populations historically under-represented in biomedical research. 118 (39%) of the 300 participants in groups 1 and 2 were prompted to self-test, with 61 (52%) successfully completing self-testing. Participants were prompted to home-test more frequently due to symptoms (41 [28%] in group 1 and 51 [34%] in group 2) than due to detected physiological changes (26 [17%] in group 1). Significantly more participants in group 1 received alerts to test than did those in group 2 (67 [45%] vs 51 [34%]; p=0·047). Of the 61 individuals who were prompted to test and successfully did so, 19 (31%) tested positive for a viral pathogen-all for SARS-CoV-2. The individuals diagnosed as positive for SARS-CoV-2 in the electronic health record were eight (5%) in group 1, four (3%) in group 2, and two (1%) in group 3, but it was difficult to confirm if they were tied to symptomatic episodes documented in the trial. There were no adverse events. In this direct-to-participant trial, we showed early feasibility of a decentralised programme to prompt individuals to use a viral pathogen diagnostic test based on symptoms tracked in the study app or physiological changes detected using a wearable sensor. Barriers to adequate participation and performance were also identified, which would need to be addressed before large-scale implementation. Janssen Pharmaceuticals.