Background. Diabetes requires significant disease management, patient-provider communication, and interaction between patients, family members, caregivers, and care teams. Emerging patient-facing technologies, such as cellular-enabled glucose meters, can facilitate additional care support and improve diabetes self-management. This study evaluated patient acceptability, feasibility, and efficacy of a diabetes care support program facilitated by cellular-enabled glucose meters. Methods. A two-phase study approach was taken. Get In Touch – Phase 1 (GIT-1) was a 1-month pilot involving patients with type 1 and type 2 diabetes. Get In Touch – Phase 2 (GIT-2) was a 12-month randomized controlled crossover trial involving patients with poorly-controlled type 2 diabetes. Results from GIT-1 and preliminary results from GIT-2 are presented. Results. GIT-1 participants with type 1 (n=6) and type 2 (n=10) diabetes reported the intervention and cellular-enabled glucose meter were easy to use and useful while identifying potential areas of improvement. GIT-2 participants in both the intervention (n=60) and control (n=60) groups saw significant improvements in treatment satisfaction and A1c change, with intervention participants experiencing slightly greater improvements in each after 6 months (p=0.09 and p=0.16, respectively) compared to control participants. Conclusions. Patients reported favorable acceptability of the intervention. Preliminary results from a randomized trial demonstrated potential of intervention to improve patient-reported and physiological health outcomes. Future studies should evaluate feasibility and efficacy over a longer period of time, with a greater number of participants, and targeting different populations of patients with diabetes. Provider perspectives and changes in provider behavior, clinical work flow, and caregiver burden should also be assessed.

No description available.

<p>In 2021, an estimated 1.5 million people were diagnosed with HIV globally, increasing the total to 38.4 million people. Approximately 16% of this population were unaware of their infected status and required HIV testing, which is a critical first step in HIV prevention, treatment, and care. Hence, there is a need to develop a rapid, user-friendly, and cost-effective point-of-care test for HIV detection. The time between HIV infection and a detectable host HIV antibody concentration can extend up to 90 days. By incorporating more sensitive testing for the HIV p24 antigen on the virus, the diagnosis lag can be reduced to 17 days. This window could be further shortened by using horseradish peroxidase (HRP) enzyme as a signal enhancement technique. The work herein focuses on developing an enzymatically signal-enhanced lateral flow assay test for the p24 antigen to detect HIV during the acute phase of infection. Conjugation chemistry for the sandwich assay was characterized using DLS and UV-Vis. Dot blots were then used to assess and enhance the functionality of the individual components via a visual color gradient formed by the protein coupled with antibody-conjugated gold nanoparticles. A quantitative analysis was performed using ImageJ software through signal pixel intensity analysis. A limit of detection (LoD) of 6 ng/mL was obtained for the detection of the p24 antigen. This LoD was improved to 0.2 ng/mL by incorporating HRP signal enhancement with the diaminobenzidine substrate. This 30x signal improvement could drive down the LoD even further to improve the sensitivity of the commercial p24 antigen tests. Different fabrication and scalability studies were performed to produce a cost- efficient, fully functional prototype of a paper-based lateral flow device incorporating the signal- enhanced p24 assay. This study serves as a solid foundation to research focused on creating more efficient point-of-care tests that can be used in resource-limited settings to provide early detection of HIV for the 6 million individuals who are currently unaware of their HIV status. </p>

<p>The 2020 pandemic emphasized the need for accessible and accurate point-of-care diagnostic tests. With the continued development of isothermal nucleic acid amplification tests, this can be achieved. A requirement of these tests includes heating and holding a specific temperature, in this case, 65C for 30 minutes, for amplification to occur. To achieve this, heaters often require external feedback to control the temperature; bringing up the device’s cost. Several self-regulating heaters have been made with materials having a positive thermal coefficient of resistance eliminating the need for complex circuitry. With this property, point-of-care diagnostic tests can be simplified and made more accessible. In this study, ink-based positive thermal coefficient of resistance heaters are developed and characterized using the scalable method of screen printing to achieve 65C and aid in the detection of SARS-CoV-2. Various curing methods and screen-printing parameters were evaluated to improve the stability and understanding of the reproducibility of the heaters. The longevity of the heaters was evaluated with oxidation studies and a COMSOL model was created to study the heat transfer within the device. Furthermore, the heaters were successfully implemented into a second-generation electronic point-of-care diagnostic device. Detection of SARS-CoV-2 using a self-regulating heater removes the need for complex circuitry, improving the accessibility of point-of-care tests with the potential to be expanded to a wide range of pathogen detection. </p>

Preterm birth (PTB) results in over 15 million early births annually and is the leading cause of neonatal deaths. There are no clinical methods currently available to evaluate risk of PTB at early stages in pregnancy; thus, a rapid diagnostic to analyze PTB risk would be beneficial. Microfluidic immunoaffinity extraction is a promising platform for preparing complex samples, such as maternal serum with PTB risk biomarkers. 3D printed microfluidic devices have advantages over conventional microfluidic systems including simple fabrication and potential for iterative optimization to improve designs. In this work, I developed immunoaffinity monoliths in 3D printed microfluidic devices modified with antibodies to enrich PTB biomarkers from human blood serum. I retained and eluted a peptide PTB biomarker in both buffer and blood serum using an immunoaffinity column. An additional three PTB biomarkers were also successfully extracted either from buffer or blood serum on single-antibody columns. Both polyclonal and monoclonal antibodies to PTB biomarkers were characterized by dot blots, biolayer interferometry, and surface plasmon resonance to determine their specificity and dissociation constants. I created multiplexed immunoaffinity columns to simultaneously enrich three PTB biomarkers from depleted human blood serum in a single extraction. This is the first demonstration of multiplexed immunoaffinity columns for PTB biomarkers in a 3D printed microfluidic device. My work is a key step towards the future development of 3D printed microfluidic devices for rapid PTB testing.

Medical-grade ultrasound devices are now pocket sized and can be easily transported to underserved parts of the world, allowing health care providers to have the tools to optimize diagnoses, inform management plans, and improve patient outcomes in remote locations. Other great advances in technology have recently occurred, such as artificial intelligence applied to mobile health devices and cloud computing, as augmented reality instructions make these devices more user friendly and readily applicable across health care encounters. However, broader awareness of the impact of these mobile health technologies is needed among health care providers, along with training on how to use them in valid and reproducible environments, for accurate diagnosis and treatment. This article provides a summary of a Mayo International Health Program journey to Bwindi, Uganda, with a portable mobile health unit. This article shows how point-of-care ultrasonography and other technologies can benefit remote clinical diagnosis and management in underserved areas around the world.

N,N′-methylenebisacrylamide-crosslinked poly(N-isopropylacrylamide), also known as P(NIPAM), was developed as a fluid delivery system for use with microfluidic paper-based analytical devices (microPADs). MicroPADs are postage-stamp-sized devices made out of paper that can be used as platforms for low-cost, simple-to-use point-of-care diagnostic assays. P(NIPAM) is a thermally responsive polymer that absorbs aqueous solutions at room temperature and will expel the solutions to microPADs when heated. The fluid delivery characteristics of P(NIPAM) were assessed, and P(NIPAM) was able to deliver multiple solutions to microPADs in specific sequences or simultaneously in a laminar-flow configuration. P(NIPAM) was then shown to be suitable for delivering four classes of reagents to microPADs: small molecules, enzymes, antibodies and DNA. P(NIPAM) successfully delivered a series of standard concentrations of glucose (0 – 5 mM) to microPADs equipped to perform a colorimetric glucose assay. The results of these tests were used to produce an external calibration curve, which in turn was used to determine accurately the concentrations of glucose in sample solutions. P(NIPAM) successfully delivered fluorescein-labeled IgG and fluorescein-labeled oligonucleotides (20 base pairs) to microPADs in a variety of concentrations. P(NIPAM) also successfully delivered horseradish peroxidase (HRP) to microPADs, and it was determined that HRP could be stored in P(NIPAM) for 35 days with minimal loss in activity. The combination of P(NIPAM) with microPADs will allow for more complex assays to be performed with minimal user input, will facilitate the preparation of external calibration curves in the field, and may be useful in extending the shelf life of microPADs by stabilizing reagents.

<p dir="ltr">Nucleic acid testing has become a prominent method for rapid microbial detection. Unlike polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP) is a simple method of nucleic acid amplification where the reaction can be performed at a constant temperature and the output provided in a colorimetric format. A transparent water bath heater is a desirable instrument to perform the heating and observe the visual results of nucleic acid amplification. However, existing methods of heating the water are not convenient for loading and unloading the nucleic acid samples. Here, we developed a field-deployable water bath heating device—an isothermal heater called IsoHeat for short–which is solely dedicated to performing LAMP reactions and can heat the water up to 85 °C (if needed). Using 3D-printing and LASER-cutting technology, we fabricated different parts of the device and mechanically assembled the parts to develop the entire device. Users can commence the heating by pressing the start button on the screen after entering the target temperature. Subsequently, the device heats up the water bath and maintains the target temperature through a PID algorithm-based control system. We demonstrate that IsoHeat can operate in environmental temperatures ranging from 5-33 °C and it can conduct LAMP reactions in a liquid format as well as in paper-based devices. IsoHeat is more efficient and user-friendly compared to a commercially available immersion-heating device, which is often used to perform LAMP reactions. This newly developed device would be helpful to detect pathogens conveniently in the field (e.g., at the point-of-care for human applications, on farms for plant and animal applications, and in production facilities for food safety applications).</p>

No description available.

No / This study aimed to compare ultrasound examinations performed within a land ambulance (stationary and moving) with those completed in a simulated emergency department (ED) to determine the feasibility of undertaking ultrasound examinations within the UK prehospital care environment. The findings suggest that abdominal aortic aneurysm and extended focused assessment with sonography in trauma emergency ultrasound examinations can be performed in the stationary or moving land ambulance environment to a standard consistent with those performed in the hospital ED.