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1.
Adv Healthc Mater ; 12(28): e2301280, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37407030

RESUMO

Diabetic foot ulcers are chronic wounds that affect millions and increase the risk of amputation and mortality, highlighting the critical need for their early detection. Recent demonstrations of wearable sensors enable real-time wound assessment, but they rely on bulky electronics, making them difficult to interface with wounds. Herein, a miniaturized, wireless, battery-free wound monitor that measures lactate in real-time and seamlessly integrates with bandages for conformal attachment to the wound bed is introduced. Lactate is selected due to its multifaceted role in initiating healing. Studies in healthy and diabetic mice reveal distinct lactate profiles for normal and impaired healing wounds. A mathematical model based on the sensor data predicts wound closure rate within the first 3 days post-injury with ≈76% accuracy, which increases to ≈83% when pH is included. These studies underscore the significance of monitoring biomarkers during the inflammation phase, which can offer several benefits, including short-term use of wound monitors and their easy removal, resulting in lower risks of injury and infection at the wound site. Improvements in prediction accuracy can be achieved by designing mathematical models that build on multiple wound parameters such as pro-inflammatory and metabolic markers. Achieving this goal will require designing multi-analyte wound monitors.


Assuntos
Diabetes Mellitus Experimental , Pé Diabético , Animais , Camundongos , Cicatrização , Bandagens , Pé Diabético/diagnóstico , Lactatos
2.
Commun Med (Lond) ; 3(1): 91, 2023 Jun 23.
Artigo em Inglês | MEDLINE | ID: mdl-37353603

RESUMO

BACKGROUND: Point-of-care diagnostic devices, such as lateral-flow assays, are becoming widely used by the public. However, efforts to ensure correct assay operation and result interpretation rely on hardware that cannot be easily scaled or image processing approaches requiring large training datasets, necessitating large numbers of tests and expert labeling with validated specimens for every new test kit format. METHODS: We developed a software architecture called AutoAdapt POC that integrates automated membrane extraction, self-supervised learning, and few-shot learning to automate the interpretation of POC diagnostic tests using smartphone cameras in a scalable manner. A base model pre-trained on a single LFA kit is adapted to five different COVID-19 tests (three antigen, two antibody) using just 20 labeled images. RESULTS: Here we show AutoAdapt POC to yield 99% to 100% accuracy over 726 tests (350 positive, 376 negative). In a COVID-19 drive-through study with 74 untrained users self-testing, 98% found image collection easy, and the rapidly adapted models achieved classification accuracies of 100% on both COVID-19 antigen and antibody test kits. Compared with traditional visual interpretation on 105 test kit results, the algorithm correctly identified 100% of images; without a false negative as interpreted by experts. Finally, compared to a traditional convolutional neural network trained on an HIV test kit, the algorithm showed high accuracy while requiring only 1/50th of the training images. CONCLUSIONS: The study demonstrates how rapid domain adaptation in machine learning can provide quality assurance, linkage to care, and public health tracking for untrained users across diverse POC diagnostic tests.


It can be difficult to correctly interpret the results of rapid diagnostic tests that give a visual readout, such as COVID rapid tests. We developed a computational algorithm to interpret rapid test results using an image taken by a smartphone camera. This algorithm can easily be adapted for use on results from different test kits. The algorithm was accurate at interpreting results obtained by members of the public using various COVID rapid tests and diagnostic tests with similar outputs used for other infections. The use of this algorithm should enable accurate interpretation of rapid diagnostic tests by members of the public and hence enable improved medical care.

3.
Arch Sex Behav ; 52(5): 1961-1968, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37188893

RESUMO

We present experiences of transgender women (TW) who have sex with men with SMARTtest, a smartphone app to accompany the INSTI Multiplex®, a one-minute, dual blood-based HIV/syphilis rapid test. TW participants (N = 11) received 10 INSTI Multiplex® tests to take home for self- and/or partner-testing and installed the SMARTtest app on their phones. The SMARTtest app aimed to support INSTI Multiplex users in correctly performing the test, interpreting the results, and connecting with care following a positive HIV or syphilis screening. After 3 months, users completed in-depth interviews on their experiences. A total of 9 TW used SMARTtest with partners. App feedback was positive, but refining is necessary. Specifically, TW reported that SMARTtest is easy to use and convenient; instructions on how to use the INSTI Multiplex presented on the app were helpful to complete procedures correctly; the most frequently used feature on SMARTtest was the information on clinics that offered confirmatory testing; and participants and their partners were not concerned about app privacy but reported that this could change if INSTI Multiplex detected an HIV-positive result. Further, participants provided recommendations on how to improve SMARTtest, and changes were mostly related to features, content, functionality, navigation, and overall "look" of the app. SMARTtest is promising to facilitate INSTI Multiplex® use in TW. User feedback should be integrated in future versions.


Assuntos
Infecções por HIV , Aplicativos Móveis , Sífilis , Pessoas Transgênero , Masculino , Humanos , Feminino , Sífilis/diagnóstico , Smartphone , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Homossexualidade Masculina
4.
Lab Chip ; 23(5): 1376-1388, 2023 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-36629022

RESUMO

Throughout the COVID-19 pandemic, we have witnessed the critical and expanding roles of testing. Despite the development of over a thousand brand of tests - with some close to fulfilling the 4As (accuracy, access, affordability, and actionability via quick time to result) of an ideal diagnostic test - gaps persisted in developing tests to fit public health needs, and in providing equitable access. Here, we review how the use cases for testing evolved over the course of the COVID-19 pandemic, with associated engineering challenges (and potential lessons) at each phase for test developers. We summarise lessons learnt from the recent epidemic and propose four areas for future cooperative effort among test developers, government regulators and policy makers, public health experts, and the public: 1) develop new models for public sector funding and research and development; 2) increase testing capacity by investing in adaptable open-platform technologies at every level of the healthcare system; 3) build data connectivity infrastructures to support a connected diagnostic system as a backbone for surveillance; and 4) facilitate the rapid translation of innovation into use through a coordinated framework for regulatory approval and policy development.


Assuntos
COVID-19 , Humanos , Pandemias , Atenção à Saúde , Teste para COVID-19
5.
Nat Nanotechnol ; 17(9): 984-992, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35879456

RESUMO

Quantitative polymerase chain reaction (qPCR) offers the capabilities of real-time monitoring of amplified products, fast detection, and quantitation of infectious units, but poses technical hurdles for point-of-care miniaturization compared with end-point polymerase chain reaction. Here we demonstrate plasmonic thermocycling, in which rapid heating of the solution is achieved via infrared excitation of nanoparticles, successfully performing reverse-transcriptase qPCR (RT-qPCR) in a reaction vessel containing polymerase chain reaction chemistry, fluorescent probes and plasmonic nanoparticles. The method could rapidly detect SARS-CoV-2 RNA from human saliva and nasal specimens with 100% sensitivity and 100% specificity, as well as two distinct SARS-CoV-2 variants. The use of small optical components for both thermocycling and multiplexed fluorescence monitoring renders the instrument amenable to point-of-care use. Overall, this study demonstrates that plasmonic nanoparticles with compact optics can be used to achieve real-time and multiplexed RT-qPCR on clinical specimens, towards the goal of rapid and accurate molecular clinical diagnostics in decentralized settings.


Assuntos
COVID-19 , Nanopartículas , COVID-19/diagnóstico , Teste para COVID-19 , RNA Polimerases Dirigidas por DNA , Corantes Fluorescentes , Humanos , Sistemas Automatizados de Assistência Junto ao Leito , RNA Viral/genética , Reação em Cadeia da Polimerase em Tempo Real , Reação em Cadeia da Polimerase Via Transcriptase Reversa , SARS-CoV-2/genética , Sensibilidade e Especificidade
6.
Angew Chem Int Ed Engl ; 61(20): e202116515, 2022 05 09.
Artigo em Inglês | MEDLINE | ID: mdl-35233907

RESUMO

Traditional implanted drug delivery systems cannot easily change their release profile in real time to respond to physiological changes. Here we present a microfluidic aqueous two-phase system to generate microcapsules that can release drugs on demand as triggered by focused ultrasound (FUS). The biphasic microcapsules are made of hydrogels with an outer phase of mixed molecular weight (MW) poly(ethylene glycol) diacrylate that mitigates premature payload release and an inner phase of high MW dextran with payload that breaks down in response to FUS. Compound release from microcapsules could be triggered as desired; 0.4 µg of payload was released across 16 on-demand steps over days. We detected broadband acoustic signals amidst low heating, suggesting inertial cavitation as a key mechanism for payload release. Overall, FUS-responsive microcapsules are a biocompatible and wirelessly triggerable structure for on-demand drug delivery over days to weeks.


Assuntos
Hidrogéis , Microfluídica , Cápsulas/química , Sistemas de Liberação de Medicamentos , Liberação Controlada de Fármacos , Ultrassonografia , Água
7.
JCI Insight ; 7(6)2022 03 22.
Artigo em Inglês | MEDLINE | ID: mdl-35230973

RESUMO

The current strategy to detect acute injury of kidney tubular cells relies on changes in serum levels of creatinine. Yet serum creatinine (sCr) is a marker of both functional and pathological processes and does not adequately assay tubular injury. In addition, sCr may require days to reach diagnostic thresholds, yet tubular cells respond with programs of damage and repair within minutes or hours. To detect acute responses to clinically relevant stimuli, we created mice expressing Rosa26-floxed-stop uracil phosphoribosyltransferase (Uprt) and inoculated 4-thiouracil (4-TU) to tag nascent RNA at selected time points. Cre-driven 4-TU-tagged RNA was isolated from intact kidneys and demonstrated that volume depletion and ischemia induced different genetic programs in collecting ducts and intercalated cells. Even lineage-related cell types expressed different genes in response to the 2 stressors. TU tagging also demonstrated the transient nature of the responses. Because we placed Uprt in the ubiquitously active Rosa26 locus, nascent RNAs from many cell types can be tagged in vivo and their roles interrogated under various conditions. In short, 4-TU labeling identifies stimulus-specific, cell-specific, and time-dependent acute responses that are otherwise difficult to detect with other technologies and are entirely obscured when sCr is the sole metric of kidney damage.


Assuntos
Injúria Renal Aguda , RNA , Animais , Perfilação da Expressão Gênica , Camundongos , RNA/metabolismo
8.
Am J Hypertens ; 35(5): 380-387, 2022 05 10.
Artigo em Inglês | MEDLINE | ID: mdl-35136906

RESUMO

Hypertension is associated with more end-organ damage, cardiovascular events, and disability-adjusted life years lost in the United States compared with all other modifiable risk factors. Several guidelines and scientific statements now endorse the use of out-of-office blood pressure (BP) monitoring with ambulatory BP monitoring or home BP monitoring to confirm or exclude hypertension status based on office BP measurement. Current ambulatory or home BP monitoring devices have been reliant on the placement of a BP cuff, typically on the upper arm, to measure BP. There are numerous limitations to this approach. Cuff-based BP may not be well-tolerated for repeated measurements as is utilized with ambulatory BP monitoring. Furthermore, improper technique, including incorrect cuff placement or use of the wrong cuff size, may lead to erroneous readings, affecting diagnosis and management of hypertension. Compared with devices that utilize a cuff, cuffless BP devices may overcome challenges related to technique, tolerability, and overall utility in the outpatient setting. However, cuffless devices have several potential limitations that limit its routine use for the diagnosis and management of hypertension. The review discusses the different approaches for determining BP using various cuffless devices including engineering aspects of cuffless device technologies, validation protocols to test accuracy of cuffless devices, potential barriers to widespread implementation, and future areas of research. This review is intended for the clinicians who utilize out-of-office BP monitoring for the diagnosis and management of hypertension.


Assuntos
Monitorização Ambulatorial da Pressão Arterial , Hipertensão , Pressão Sanguínea/fisiologia , Determinação da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/métodos , Humanos , Hipertensão/diagnóstico , Hipertensão/terapia , Reprodutibilidade dos Testes , Esfigmomanômetros
9.
Sci Rep ; 12(1): 559, 2022 01 11.
Artigo em Inglês | MEDLINE | ID: mdl-35017558

RESUMO

Identification of cognate interactions between antigen-specific T cells and dendritic cells (DCs) is essential to understanding immunity and tolerance, and for developing therapies for cancer and autoimmune diseases. Conventional techniques for selecting antigen-specific T cells are time-consuming and limited to pre-defined antigenic peptide sequences. Here, we demonstrate the ability to use deep learning to rapidly classify videos of antigen-specific CD8+ T cells. The trained model distinguishes distinct interaction dynamics (in motility and morphology) between cognate and non-cognate T cells and DCs over 20 to 80 min. The model classified high affinity antigen-specific CD8+ T cells from OT-I mice with an area under the curve (AUC) of 0.91, and generalized well to other types of high and low affinity CD8+ T cells. The classification accuracy achieved by the model was consistently higher than simple image analysis techniques, and conventional metrics used to differentiate between cognate and non-cognate T cells, such as speed. Also, we demonstrated that experimental addition of anti-CD40 antibodies improved model prediction. Overall, this method demonstrates the potential of video-based deep learning to rapidly classify cognate T cell-DC interactions, which may also be potentially integrated into high-throughput methods for selecting antigen-specific T cells in the future.


Assuntos
Linfócitos T CD8-Positivos
10.
AIDS Behav ; 26(1): 35-46, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34037931

RESUMO

At home self- and partner-testing may reduce HIV and syphilis transmission by detecting undiagnosed infections. Forty-eight cisgender men and transgender women who men who have sex with men were given ten INSTI Multiplex kits and downloaded the SMARTtest app to facilitate self- and partner testing over the next three months. Thirty-seven (77%) participants self-tested using the INSTI (mean = 3.7 times, SD = 3.9); 26 (54%) tested partners (mean = 1.6 times, SD = 2.2). Participants liked the test for its ease of use, quick results, and dual HIV/syphilis testing but its blood-based nature hindered use with partners. Participants with reactive syphilis results always attributed them to a past infection and these results presented a challenge to testing with partners and the ability to accurately assess risk of infection. Most participants stated they would use the INSTI for self-testing (100%) and for partner-testing (89%). Acceptability of the SMARTtest app was high for functionality (M = 4.16 of max 5, SD = 0.85) and helpfulness (M = 6.12 of max 7, SD = 1.09). Participants often used the app as needed, eschewing its use if they felt comfortable conducting the test and interpreting its results. Seventy-eight percent would recommend the app to a friend. Availability of the INSTI Multiplex as a self-test with the accompanying SMARTtest app might increase frequency of HIV and syphilis testing, allowing for earlier detection of infection and reduced transmission.


RESUMEN: El uso de pruebas rápidas caseras con parejas y como auto-pruebas puede reducir la transmisión del VIH y la sifilis al detectar infecciones no diagnosticadas. Cuarenta y ocho hombres cisgénero y mujeres transgénero que tienen sexo con hombres recibieron diez kits del INSTI Multiplex y descargaron la aplicación SMARTtest para facilitar su uso con parejas y para auto-pruebas durante los próximos tres meses. Treinta y siete (77%) participantes se auto-testearon utilizando el INSTI (media = 3.7 veces, DE = 3.9); 26 (54%) testearon a sus parejas (media = 1.6 veces, DE = 2.2). A los participantes les gustó la prueba por su facilidad de uso, rapidez de los resultados y por ser una prueba dual de VIH/sífilis, pero al ser una prueba basada en sangre dificultó su uso con parejas. Los participantes con resultados de sífilis reactivos siempre atribuyeron éstos a una infección pasada y sus resultados presentaron un desafío para el uso de pruebas con parejas. La mayoría de los participantes afirmaron que utilizarían el INSTI como auto-pruebas (100%) y para testear a sus parejas (89%). La aceptabilidad de la aplicación SMARTtest fue alta para la funcionalidad (M = 4.16 de un máximo de 5, SD = 0.85) y utilidad (M = 6.13 de un máximo de 7, SD = 1.09). Los participantes solían utilizar la aplicación según fuera necesario, evitando su uso si se sentían cómodos realizando la prueba e interpretando sus resultados. El 78% recomendaría la aplicación a un amigo. La disponibilidad del INSTI Multiplex como auto-prueba con la aplicación SMARTtest podría aumentar la frecuencia de las pruebas de VIH y sífilis, lo que permite una detección más temprana de la infección y reduce la transmisión.


Assuntos
Infecções por HIV , Aplicativos Móveis , Minorias Sexuais e de Gênero , Sífilis , Pessoas Transgênero , Feminino , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Homossexualidade Masculina , Humanos , Masculino , Sífilis/diagnóstico
11.
Lab Chip ; 21(23): 4517-4548, 2021 11 25.
Artigo em Inglês | MEDLINE | ID: mdl-34778896

RESUMO

In this review, we provide an overview of developments in point-of-care (POC) diagnostics during the COVID-19 pandemic. We review these advances within the framework of a holistic POC ecosystem, focusing on points of interest - both technological and non-technological - to POC researchers and test developers. Technologically, we review design choices in assay chemistry, microfluidics, and instrumentation towards nucleic acid and protein detection for severe acute respiratory coronavirus 2 (SARS-CoV-2), and away from the lab bench, developments that supported the unprecedented rapid development, scale up, and deployment of POC devices. We describe common features in the POC technologies that obtained Emergency Use Authorization (EUA) for nucleic acid, antigen, and antibody tests, and how these tests fit into four distinct POC use cases. We conclude with implications for future pandemics, infectious disease monitoring, and digital health.


Assuntos
COVID-19 , Pandemias , Ecossistema , Humanos , Sistemas Automatizados de Assistência Junto ao Leito , SARS-CoV-2
12.
Kidney Int Rep ; 5(11): 1982-1992, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33163719

RESUMO

INTRODUCTION: The identification of acute injury of the kidney relies on serum creatinine (SCr), a functional marker with poor temporal resolution as well as limited sensitivity and specificity for cellular injury. In contrast, urinary biomarkers of kidney injury have the potential to detect cellular stress and damage in real time. METHODS: To detect the response of the kidney to injury, we have tested a lateral flow dipstick that measures a urinary protein called neutrophil gelatinase-associated lipocalin (NGAL). Analysis of urine was performed in a prospective cohort of 479 patients (final cohort N = 426) entering an emergency department in New York City and subsequently admitted for inpatient care. RESULTS: Colorimetric development had high interrater reliability (88% concordance rate) and correlated with traditional enzyme-linked immunosorbent assay (ELISA) measurements (ρ = 0.732, P < .0001). Of the 14% of the cohort who met Acute Kidney Injury Network (AKIN) SCr criteria for acute kidney injury (AKI), 67% demonstrated transient (<2 days) and 33% demonstrated sustained (>2 days) elevation of SCr. Comparing the outcomes of patients with sustained versus transient or undetectable changes in SCr revealed that the urinary NGAL (uNGAL) dipstick had high specificity and negative predictive value (NPV) (high- vs. low-intermediate readings, sensitivity = 0.55, specificity = 0.91, positive predictive value = 0.24, NPV = 0.97, χ2 = 20.39, P < 0.001). CONCLUSION: We show that the introduction of a bedside uNGAL dipstick permits accurate triage by identifying individuals who do not have tubular injury. In an era of shortening length of stay and rapid decisions based on isolated SCr measurements, real-time exclusion of kidney injury by a dipstick will be particularly useful to overcome the retrospective, insensitive, and nonspecific attributes of SCr.

13.
Adv Mater Technol ; 5(3)2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33043127

RESUMO

Advances in mobile biosensors, integrating developments in materials science and instrumentation, are fueling an expansion in health data being collected and analyzed in decentralized settings. For example, semiconductor-based sensors are enabling measurement of vital signs, and microfluidic-based sensors are enabling measurement of biochemical markers. As biosensors for mobile health are becoming increasingly paired with smart devices, it will become critical for researchers to design biosensors - with appropriate functionalities and specifications - to work seamlessly with accompanying connected hardware and software. This article describes recent research in biosensors, as well as current mobile health devices in use, as classified into four distinct system architectures that take into account the biosensing and data processing functions required in personal mobile health devices. We also discuss the path forward for integrating biosensors into smartphone-based mobile health devices.

14.
iScience ; 23(5): 101052, 2020 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-32353766

RESUMO

Organoids are becoming widespread in drug-screening technologies but have been used sparingly for cell therapy as current approaches for producing self-organized cell clusters lack scalability or reproducibility in size and cellular organization. We introduce a method of using hydrogels as sacrificial scaffolds, which allow cells to form self-organized clusters followed by gentle release, resulting in highly reproducible multicellular structures on a large scale. We demonstrated this strategy for endothelial cells and mesenchymal stem cells to self-organize into blood-vessel units, which were injected into mice, and rapidly formed perfusing vasculature. Moreover, in a mouse model of peripheral artery disease, intramuscular injections of blood-vessel units resulted in rapid restoration of vascular perfusion within seven days. As cell therapy transforms into a new class of therapeutic modality, this simple method-by making use of the dynamic nature of hydrogels-could offer high yields of self-organized multicellular aggregates with reproducible sizes and cellular architectures.

15.
AIDS Behav ; 24(5): 1560-1573, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31679075

RESUMO

Acceptability of rapid HIV self-testing is high but potential users remain concerned about correct use, interpretation of test results, and linkage to care. This article describes user preferences for a smartphone app to mitigate these challenges and how these were integrated into the SMARTtest app to support self- and partner-testing using the INSTI Multiplex®. Sixty men and transgender women who have sex with men self-tested for HIV and syphilis while guided by a prototype app that provided a video, pictorial step-by-step instructions, and sample test results presented textually ("positive," "negative"). Subsequently, participants provided feedback on revisions and additional app content. Participants recommended offering different user modes (self, partner, both), and retaining the video, step-by-step instructions, and textual test results. They strongly favored the ability to save and send test results to sexual partners or providers. These features were integrated into the SMARTtest app to facilitate HIV/syphilis self- and partner-testing, HIV/syphilis status awareness and disclosure, and linkage to care.


Assuntos
Infecções por HIV , Smartphone , Sífilis , Adulto , Idoso , Feminino , Identidade de Gênero , Infecções por HIV/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Parceiros Sexuais , Sífilis/diagnóstico , Adulto Jovem
16.
iScience ; 21: 328-340, 2019 Nov 22.
Artigo em Inglês | MEDLINE | ID: mdl-31698247

RESUMO

Digital health promises a paradigm shift for medicine where biomarkers in individuals are continuously monitored to improve diagnosis and treatment of disease. To that end, a technology for minimally invasive quantification of endogenous analytes in bodily fluids will be required. Here, we describe a strategy for designing and fabricating hydrogel microfilaments that can penetrate the skin while allowing for optical fluorescence sensing. The polyacrylamide formulation was selected to provide high elastic modulus in the dehydrated state and optical transparency in the hydrated state. The microfilaments can be covalently tethered to a fluorescent aptamer to enable functional sensing. The microfilament array can penetrate the skin with low pain and without breaking, contact the dermal interstitial fluid, and be easily removed from the skin. In the future, hydrogel microfilaments could be integrated with a wearable fluorometer to serve as a platform for continuous, minimally invasive monitoring of intradermal biomarkers.

17.
J Clin Microbiol ; 57(12)2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31597750

RESUMO

Single multiplexed assays could replace the standard 2-tiered (STT) algorithm recommended for the laboratory diagnosis of Lyme disease if they perform with a specificity and a sensitivity superior or equal to those of the STT algorithm. We used human serum rigorously characterized to be sera from patients with acute- and convalescent-phase early Lyme disease, Lyme arthritis, and posttreatment Lyme disease syndrome, as well as the necessary controls (n = 241 samples), to select the best of 12 Borrelia burgdorferi proteins to improve our microfluidic assay (mChip-Ld). We then evaluated its serodiagnostic performance in comparison to that of a first-tier enzyme immunoassay and the STT algorithm. We observed that more antigens became positive as Lyme disease progressed from early to late stages. We selected three antigens (3Ag) to include in the mChip-Ld: VlsE and a proprietary synthetic 33-mer peptide (PepVF) to capture sensitivity in all disease stages and OspC for early Lyme disease. With the specificity set at 95%, the sensitivity of the mChip-Ld with 3Ag ranged from 80% (95% confidence interval [CI], 56% to 94%) and 85% (95% CI, 74% to 96%) for two panels of serum from patients with early Lyme disease and was 100% (95% CI, 83% to 100%) for serum from patients with Lyme arthritis; the STT algorithm detected early Lyme disease in the same two panels of serum from patients with early Lyme disease with a sensitivity of 48.5% and 75% and Lyme arthritis in serum from patients with Lyme arthritis with a sensitivity of 100%, and the specificity was 97.5% to 100%. The mChip-Ld platform outperformed the STT algorithm according to sensitivity. These results open the door for the development of a single, rapid, multiplexed diagnostic test for point-of-care use that can be designed to identify the Lyme disease stage.


Assuntos
Borrelia burgdorferi/imunologia , Doença de Lyme/diagnóstico , Microfluídica/métodos , Sistemas Automatizados de Assistência Junto ao Leito , Testes Sorológicos/métodos , Humanos , Sensibilidade e Especificidade
18.
Lab Chip ; 19(13): 2241-2255, 2019 06 25.
Artigo em Inglês | MEDLINE | ID: mdl-31168548

RESUMO

With point-of-care (POC) diagnostic devices becoming increasingly available to untrained users, it will be critical to understand how real-world user behavior can best inform and guide the engineering design process. Social sciences present frameworks for analyzing user behavior, but they have not yet been applied to POC diagnostics in a methodical manner. Here, we develop a framework that synthesizes two models that can collectively account for user behavior and experience with POC diagnostic devices: a social psychological information-motivation-behavior (IMB) model (first described by Fisher and Fisher) for identifying determinants for health-related behavior, and user experience (UX) elements for studying interactions between users and products. Based on studies of 40 naïve users of our smartphone-enabled microfluidics device that can be used for HIV home-testing, we found that untrained participants could perform 90% of steps correctly, with engineering design elements that provided feedback that was either direct (e.g., a light or click) or binary (e.g., a switch) enhancing usability. Interestingly, of the steps performed incorrectly, over 70% were due not to errors in the device or user operation, but user-to-user variability (e.g. time in collecting fingerstick and force applied to initiate vacuum), which could be addressed by further modifications to the device. Overall, this study suggests that microfluidic POC HIV home-testing is likely to benefit from smartphone integration, and that engineering design of POC diagnostic devices can benefit from a structured evaluation of user behavior and experience, as guided by a social-psychological framework, which emphasizes user credibility, accessibility, acceptability, usability, and value.


Assuntos
Telefone Celular , Dispositivos Lab-On-A-Chip , Técnicas Analíticas Microfluídicas , Sistemas Automatizados de Assistência Junto ao Leito , Kit de Reagentes para Diagnóstico , Engenharia Tecidual , Adulto , Idoso , Telefone Celular/instrumentação , Feminino , Infecções por HIV/diagnóstico , Humanos , Técnicas Analíticas Microfluídicas/instrumentação , Pessoa de Meia-Idade , Adulto Jovem
19.
JMIR Public Health Surveill ; 4(3): e11203, 2018 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-30087088

RESUMO

BACKGROUND: Precise measurements of HIV incidences at community level can help mount a more effective public health response, but the most reliable methods currently require labor-intensive population surveys. Novel mobile phone technologies are being tested for adherence to medical appointments and antiretroviral therapy, but using them to track HIV test results with automatically generated geospatial coordinates has not been widely tested. OBJECTIVE: We customized a portable reader for interpreting the results of HIV lateral flow tests and developed a mobile phone app to track HIV test results in urban and rural locations in Rwanda. The objective was to assess the feasibility of this technology to collect front line HIV test results in real time and with geospatial context to help measure HIV incidences and improve epidemiological surveillance. METHODS: Twenty health care workers used the technology to track the test results of 2190 patients across 3 hospital sites (2 urban sites in Kigali and a rural site in the Western Province of Rwanda). Mobile phones for less than US $70 each were used. The mobile phone app to record HIV test results could take place without internet connectivity with uploading of results to the cloud taking place later with internet. RESULTS: A total of 91.51% (2004/2190) of HIV test results could be tracked in real time on an online dashboard with geographical resolution down to street level. Out of the 20 health care workers, 14 (70%) would recommend the lateral flow reader, and 100% would recommend the mobile phone app. CONCLUSIONS: Smartphones have the potential to simplify the input of HIV test results with geospatial context and in real time to improve public health surveillance of HIV.

20.
J Vis Exp ; (137)2018 07 18.
Artigo em Inglês | MEDLINE | ID: mdl-30080207

RESUMO

Polyethylene glycol (PEG)-based hydrogels are biocompatible hydrogels that have been approved for use in humans by the FDA. Typical PEG-based hydrogels have simple monolithic architectures and often function as scaffolding materials for tissue engineering applications. More sophisticated structures typically take a long time to fabricate and do not contain moving components. This protocol describes a photolithography method that allows for facile and rapid microfabrication of PEG structures and devices. This strategy involves an in-house developed fabrication stage that allows for the rapid fabrication of 3D structures by building upwards in a layer-by-layer fashion. Independent moving components can also be aligned and assembled onto support structures to form integrated devices. These independent components are doped with superparamagnetic iron oxide nanoparticles that are sensitive to magnetic actuation. In this manner, the fabricated devices can be actuated using external magnets to yield movement of the components within. Hence, this technique allows for the fabrication of sophisticated MEMS-like devices (micromachines) that are composed entirely out of a biocompatible hydrogel, able to function without an onboard power source, and respond to a contact-less method of actuation. This manuscript describes the fabrication of both the fabrication set-up as well as the step-by-step method for the microfabrication of these hydrogels-based MEMS-like devices.


Assuntos
Hidrogéis/química , Microtecnologia/métodos , Engenharia Tecidual/métodos , Humanos
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