Ease of Use Considerations for Wearable Point-Of-Care Devices in Home Environments

Background: Thrombelastography (TEG) is an established but labor intensive method for assessing global hemostasis for the management of bleeding and thrombotic risk in surgical, cardiovascular, and trauma patients. We performed the initial validation study of the first true point-of-care TEG, the CORA® (COagulation Resonance Analyzer or TEG-6S system). CORA uses resonance-frequency viscoelasticity measurements and a disposable multi-channel microfluidic cartridge to assess hemostasis and response to antiplatelet therapy. Methods: TEG assays (n=5,100) were performed from the blood of healthy volunteers (n=160) and patients undergoing coronary revascularization (n=300) collected at 3 hospitals. Quality controls were also assayed. The performance of the TEG-6S system was compared with the conventional TEG 5000 system in accordance with Clinical Laboratory Standards Institute Guidelines. Results: Regression analysis demonstrated a strong correlation (R) between the two systems by all standard measures and a lower coefficient of variation (CV %) with the CORA system at all hospitals (Table). Receiver operating characteristic (ROC) curve analysis showed an excellent correlation between platelet mapping methods (AUC≥0.90, p<0.001) and there was a substantial agreement for measuring antiplatelet response to aspirin (k=0.67, agreement=87%) and P2Y12 inhibitors (k=0.69, agreement=86%). Conclusion: The new point-of-care TEG-6S system is associated with improved precision, greater ease of use, and a strong correlation as compared to the conventional TEG 5000 system. The TEG-6S will facilitate future trials of personalized antiplatelet therapy and improve the assessment of bleeding and thrombotic risk in cardiovascular, surgical, and trauma patients.

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Direct-RT-qPCR Detection of SARS-CoV-2 without RNA Extraction as Part of a COVID-19 Testing Strategy: From Sample to Result in One Hour

Diagnostics ◽

10.3390/diagnostics10080605 ◽

2020 ◽

Vol 10 (8) ◽

pp. 605 ◽

Cited By ~ 3

Author(s):

Eva Kriegova ◽

Regina Fillerova ◽

Petr Kvapil

Keyword(s):

High Throughput Screening ◽

High Speed ◽

Limit Of Detection ◽

Point Of Care ◽

Rna Extraction ◽

Rna Isolation ◽

High Sensitivity ◽

Ease Of Use ◽

Diagnostic Tools ◽

Heat Inactivation

Due to the lack of protective immunity in the general population and the absence of effective antivirals and vaccines, the Coronavirus disease 2019 (COVID-19) pandemic continues in some countries, with local epicentres emerging in others. Due to the great demand for effective COVID-19 testing programmes to control the spread of the disease, we have suggested such a testing programme that includes a rapid RT-qPCR approach without RNA extraction. The Direct-One-Step-RT-qPCR (DIOS-RT-qPCR) assay detects severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in less than one hour while maintaining the high sensitivity and specificity required of diagnostic tools. This optimised protocol allows for the direct use of swab transfer media (14 μL) without the need for RNA extraction, achieving comparable sensitivity to the standard method that requires the time-consuming and costly step of RNA isolation. The limit of detection for DIOS-RT-qPCR was lower than seven copies/reaction, which translates to 550 virus copies/mL of swab. The speed, ease of use and low price of this assay make it suitable for high-throughput screening programmes. The use of fast enzymes allows RT-qPCR to be performed under standard laboratory conditions within one hour, making it a potential point-of-care solution on high-speed cycling instruments. This protocol also implements the heat inactivation of SARS-CoV-2 (75 °C for 10 min), which renders samples non-infectious, enabling testing in BSL-2 facilities. Moreover, we discuss the critical steps involved in developing tests for the rapid detection of COVID-19. Implementing rapid, easy, cost-effective methods can help control the worldwide spread of the COVID-19 infection.

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Advantages of Graphene Biosensors for Human Stem Cell Therapy Potency Assays

BioMed Research International ◽

10.1155/2018/1676851 ◽

2018 ◽

Vol 2018 ◽

pp. 1-12 ◽

Cited By ~ 3

Author(s):

Roxana-Maria Amărandi ◽

Diana F. Becheru ◽

George M. Vlăsceanu ◽

Mariana Ioniță ◽

Jorge S. Burns

Keyword(s):

Stem Cell ◽

Cell Therapy ◽

Point Of Care ◽

Cell Types ◽

Small Sample ◽

Ease Of Use ◽

Potency Assay ◽

Cell Therapies ◽

Potential Biomarker ◽

Effective Development

Regenerative medicine is challenged by the need to conform to rigorous guidelines for establishing safe and effective development and translation of stem cell-based therapies. Counteracting widespread concerns regarding unproven cell therapies, stringent cell-based assays seek not only to avoid harm but also to enhance quality and efficacy. Potency indicates that the cells are functionally fit for purpose before they are administered to the patient. It is a paramount quantitative critical quality attribute serving as a decisive release criterion. Given a broad range of stem cell types and therapeutic contexts the potency assay often comprises one of the most demanding hurdles for release of a cell therapy medicinal product. With need for improved biomarker assessment and expedited measurement, recent advances in graphene-based biosensors suggest that they are poised to be valuable platforms for accelerating potency assay development. Among several potential advantages, they offer versatility for sensitive measurement of a broad range of potential biomarker types, cell biocompatibility for direct measurement, and small sample sufficiency, plus ease of use and point-of-care applicability.

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Two Potential Clinical Applications of Origami-Based Paper Devices

Diagnostics ◽

10.3390/diagnostics9040203 ◽

2019 ◽

Vol 9 (4) ◽

pp. 203

Author(s):

Zong-Keng Kuo ◽

Tsui-Hsuan Chang ◽

Yu-Shin Chen ◽

Chao-Min Cheng ◽

Chia-Ying Tsai

Keyword(s):

Limit Of Detection ◽

Point Of Care ◽

Test Sample ◽

Clinical Applications ◽

Ease Of Use ◽

Enzyme Linked Immunosorbent Assay ◽

Elisa System ◽

Test Zone ◽

Moist Environment ◽

Simplex Virus

Detecting small amounts of analyte in clinical practice is challenging because of deficiencies in specimen sample availability and unsuitable sampling environments that prevent reliable sampling. Paper-based analytical devices (PADs) have successfully been used to detect ultralow amounts of analyte, and origami-based PADs (O-PADs) offer advantages that may boost the overall potential of PADs in general. In this study, we investigated two potential clinical applications for O-PADs. The first O-PAD we investigated was an origami-based enzyme-linked immunosorbent assay (ELISA) system designed to detect different concentrations of rabbit IgG. This device was designed with four wing structures, each of which acted as a reagent loading zone for pre-loading ELISA reagents, and a central test sample loading zone. Because this device has a low limit of detection (LOD), it may be suitable for detecting IgG levels in tears from patients with a suspected viral infection (such as herpes simplex virus (HSV)). The second O-PAD we investigated was designed to detect paraquat levels to determine potential poisoning. To use this device, we sequentially folded each of two separate reagent zones, one preloaded with NaOH and one preloaded with ascorbic acid (AA), over the central test zone, and added 8 µL of sample that then flowed through each reagent zone and onto the central test zone. The device was then unfolded to read the results on the test zone. The three folded layers of paper provided a moist environment not achievable with conventional paper-based ELISA. Both O-PADs were convenient to use because reagents were preloaded, and results could be observed and analyzed with image analysis software. O-PADs expand the testing capacity of simpler PADs while leveraging their characteristic advantages of convenience, cost, and ease of use, particularly for point-of-care diagnosis.

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Usability Evaluation of User Requirement–Based Teleconsultation Robots: A Preliminary Report from South Korea

Methods of Information in Medicine ◽

10.1055/s-0040-1715579 ◽

2020 ◽

Vol 59 (02/03) ◽

pp. 086-095

Author(s):

Hyeongsuk Lee ◽

Jeongeun Kim ◽

Sukwha Kim ◽

Hyoun-Joong Kong ◽

Hyunjin Joo ◽

...

Keyword(s):

Health Care ◽

User Interface ◽

Point Of Care ◽

Healthcare Providers ◽

Usability Evaluation ◽

Ease Of Use ◽

Perceived Usefulness ◽

Perceived Ease Of Use ◽

User Requirement ◽

Effective Decision Making

Abstract Background Telepresence robots used to deliver a point-of-care (POC) consultation system that may provide value to enable effective decision making by healthcare providers at care sites. Objectives This study aimed to evaluate usability of teleconsultation robots, based on endusers' needs, that can improve acceptance in future robot applications. Methods This is a single group postdesign study using mixed methods to assess the usability of teleconsultation robots using scenarios. To collect opinions from various departments, 15 nurses or physicians currently working at medical institutions in Korea were selected using purposive sampling. The usability evaluation was conducted on healthcare providers twice at the simulation center; the think-aloud method was used and surveys and interviews were conducted to identify problems or improvements that may arise from the use of robots in hospital settings. Results The results showed that perceived usefulness, perceived ease of use, and satisfaction level each scored 4 points or higher out of 7 points, showing usability of midhigh level. Camera angle control and robot driving functions were the most difficult. Other basic robot user interface was shown to be relatively easy. There was no difference in usability depending on the characteristics of the evaluator. Some functions including user interface were modified based on the usability test. Conclusion Using robots in health care institutions may support effective communication among healthcare providers, thus contributing to health care improvement.

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Performance and ease of use of a molecular point-of-care test for influenza A/B and RSV in patients presenting to primary care

European Journal of Clinical Microbiology & Infectious Diseases ◽

10.1007/s10096-020-03860-5 ◽

2020 ◽

Vol 39 (8) ◽

pp. 1453-1460

Author(s):

Jan Y Verbakel ◽

Veerle Matheeussen ◽

Katherine Loens ◽

Mandy Kuijstermans ◽

Herman Goossens ◽

...

Keyword(s):

Primary Care ◽

Influenza A ◽

Point Of Care ◽

Ease Of Use ◽

Point Of Care Test

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Initial Experience with Cancer Guidelines Navigator, a tool to standardize and improve the quality of cancer care in Sub-Saharan Africa, at Ocean Road Cancer Institute in Tanzania.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e14106 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e14106-e14106

Author(s):

Fernando Jose Suarez Saiz ◽

Leemor Yuravlivker ◽

Jerry Ndumbalo ◽

Julius Mwaiselage ◽

Sadiq Maalim Siu ◽

...

Keyword(s):

Cancer Treatment ◽

Treatment Planning ◽

Reference System ◽

Point Of Care ◽

Lessons Learned ◽

Ease Of Use ◽

Sub Saharan Africa ◽

Digital Reference ◽

Sub Saharan ◽

Cancer Guidelines

e14106 Background: The IBM Cancer Guidelines Navigator (CGN) is a digital reference system to support treatment planning that allows clinicians to enter a cancer patient’s clinical characteristics and presents the corresponding treatment options in the NCCN Harmonized Guidelines (TM) for Sub-Saharan Africa. In October 2019, Ocean Road Cancer Institute (ORCI) in Tanzania became the first site in Africa to initiate a hospital-wide implementation of the tool to help clinicians reduce cancer treatment variability by increasing adherence to standard evidence-based care. We describe training and lessons learned from system introduction. Methods: Training for clinical staff at ORCI occurred over one week and included daily one-hour lectures, followed by personalized hands-on training. A survey was administered to assess usability and use cases of the tool. Results: Thirty-one ORCI clinical and IT staff members participated in training, and 12 completed the survey. Responses indicated that the most beneficial uses for CGN were at point of care and for self-learning. Participants indicated that the top benefits of the tool were quick access to guidelines and evidence (75%) and ease of use (58%). Expanding cancer coverage (42%), offline access and better integration into the workflow (25%) were identified as areas for improvement. Post-training, ORCI implemented easier access to CGN on each computer and tablet used for consultation and care management. Conclusions: CGN is a digital reference system that is designed to support easy and efficient access to regionalized cancer-treatment guidelines for point-of-care treatment planning and education. Expansion of this program has been planned for other hospitals in Tanzania. Future studies will examine whether CGN usage affects guideline adherence.

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A field evaluation of a new molecular-based point-of-care test for chlamydia and gonorrhoea in remote Aboriginal health services in Australia

Sexual Health ◽

10.1071/sh14158 ◽

2015 ◽

Vol 12 (1) ◽

pp. 27 ◽

Cited By ~ 14

Author(s):

Louise M. Causer ◽

Belinda Hengel ◽

Lisa Natoli ◽

Annie Tangey ◽

Steven G. Badman ◽

...

Keyword(s):

Health Services ◽

Sensitivity And Specificity ◽

Point Of Care ◽

Simultaneous Detection ◽

Field Evaluation ◽

Aboriginal Health ◽

Ease Of Use ◽

Nucleic Acid Amplification ◽

Specimen Preparation ◽

Sexually Transmissible Infections

Background Point-of-care (POC) tests could be important public health tools in settings with treatment delays and high rates of sexually transmissible infections (STIs). Use is limited due to suboptimal performance. The performance and ease-of-use of a new molecular-based POC test for simultaneous detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) was assessed, alongside two single-organism immunochromatographic tests (ICT). Methods: The evaluation occurred between May 2012 and March 2013 during community STI screens in two remote Aboriginal health services. Urine was tested with the GeneXpert®CT/NG and if sufficient volume, also with Diaquick CT and Gonorrhoea Card. The gold standard comparison was laboratory nucleic acid amplification testing (NAAT). Operational characteristics were also assessed. Results: Among 198 samples, GeneXpert CT sensitivity and specificity was 100% [95% confidence intervals (CI): 75.9–100] and 99.5% (95% CI: 96.5–100), and NG was 100% (95% CI: 96.5–100) and 100% (95% CI: 97.5–100), respectively. Among a sample subset, Diaquick CT (n = 104) sensitivity and specificity was 27.3% (95% CI: 7.3–60.7) and 66.7% (95% CI: 12.5–98.2), and Gonorrhoea Card (n = 29), was 66.7% (95% CI: 12.5–98.2) and 76.9% (95% CI: 56.0–90.2), respectively. GeneXpert required 1 mL of urine, four steps, 1 min specimen preparation and 90 min to result. ICTs required 15 mL of urine, eight steps, 18 min preparation and 10–15 min to result. Conclusion: The accuracy and operational benefits of GeneXpert CT/NG make it very suitable in these settings where delays to treatment are encountered.

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Multiplex logic processing isothermal diagnostic assays for an evolving virus

10.1101/424440 ◽

2018 ◽

Author(s):

Sanchita Bhadra ◽

Miguel A. Saldaña ◽

Hannah Grace Han ◽

Grant L. Hughes ◽

Andrew D. Ellington

Keyword(s):

Point Of Care ◽

Direct Analysis ◽

Human Saliva ◽

Ease Of Use ◽

Molecular Diagnostic ◽

One Pot ◽

Diagnostic Assays ◽

Specificity And Sensitivity ◽

Isothermal Assay ◽

Fail Safe

AbstractWe have developed a generalizable ‘smart molecular diagnostic’ capable of accurate point-of-care (POC) detection of variable nucleic acid targets. Our one-pot isothermal assay relies on multiplex execution of four loop-mediated isothermal amplification reactions, with primers that are degenerate and redundant, thereby increasing the breadth of targets while reducing the probability of amplification failure. An easy-to-read visual answer is computed directly by a multi-input Boolean OR gate signal transducer that uses degenerate strand exchange probes to assess any combination of amplicons. We demonstrate our platform by using the same assay to detect divergent Asian and African lineages of the evolving Zika virus (ZIKV), while maintaining selectivity against non-target viruses. Direct analysis of biological specimens proved possible, with 20 virions / µl being directly detected in human saliva within 90 minutes, and crudely macerated ZIKV-infected Aedes aegypti mosquitoes being identified with 100% specificity and sensitivity. The ease-of-use with minimal instrumentation, broad programmability, and built-in fail-safe reliability make our smart molecular diagnostic attractive for POC use.

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Point-of-Care Viscosity Surrogate Measurement Through Utilization of Smartphone Sensors and Custom 3D Printed Design

2020 Design of Medical Devices Conference ◽

10.1115/dmd2020-9004 ◽

2020 ◽

Author(s):

Awaiz Khan ◽

Edmundo Rubio ◽

Bradley Icard

Keyword(s):

Clinical Trial ◽

Point Of Care ◽

Ease Of Use ◽

Mechanically Ventilated ◽

Mechanically Ventilated Patients ◽

Smartphone Sensors ◽

3D Printed ◽

Surrogate Measurement ◽

Surrogate Measure ◽

Ventilated Patients

Abstract This project sought to develop a method to provide a clinically meaningful, surrogate measure for viscosity that will help analyze complex biofluids. Goals for this project included precise measurements that differentiate a wide variety of standard viscosities, table-top level of size, and ease-of-use. The design utilized a custom 3D-printed analog of a cone and plate viscometer with an attachment for a smartphone to provide gyroscopic data. The device is currently in the stages of final validation and will ultimately be tested in a 40-patient clinical trial intended to assess efficacy of mucolytic therapy in mechanically ventilated patients.

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