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Feasibility of a Novel Mobile C-Reactive Protein–Testing Device Using Gold-Linked Electrochemical Immunoassay: Clinical Performance Study

BACKGROUND: Home-based care is one of the most promising solutions to provide sufficient medical care for several older patients in Japan. However, because of insufficient diagnostic devices, it is sometimes difficult to detect early signs of the occurrence or worsening of diseases, such as infectio...

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Autores principales: Gondoh-Noda, Yuko, Kometani, Mitsuhiro, Nomura, Akihiro, Aono, Daisuke, Karashima, Shigehiro, Ushijima, Hiromi, Tamiya, Eiichi, Murayama, Toshinori, Yoneda, Takashi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7506539/
https://www.ncbi.nlm.nih.gov/pubmed/32894233
http://dx.doi.org/10.2196/18782
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author Gondoh-Noda, Yuko
Kometani, Mitsuhiro
Nomura, Akihiro
Aono, Daisuke
Karashima, Shigehiro
Ushijima, Hiromi
Tamiya, Eiichi
Murayama, Toshinori
Yoneda, Takashi
author_facet Gondoh-Noda, Yuko
Kometani, Mitsuhiro
Nomura, Akihiro
Aono, Daisuke
Karashima, Shigehiro
Ushijima, Hiromi
Tamiya, Eiichi
Murayama, Toshinori
Yoneda, Takashi
author_sort Gondoh-Noda, Yuko
collection PubMed
description BACKGROUND: Home-based care is one of the most promising solutions to provide sufficient medical care for several older patients in Japan. However, because of insufficient diagnostic devices, it is sometimes difficult to detect early signs of the occurrence or worsening of diseases, such as infections under home-based care settings. C-reactive protein (CRP) is highly sensitive to diagnosing infections, and its elevation can help diagnose acute infection in older patients. Therefore, a CRP-measuring device that can be used in such a specific occasion is needed for home-based care. However, aspects such as its size, weight, and procedure are still challenging with respect to the practical use of mobile devices that quantitatively measure CRP levels easily and quickly under home-based care settings. OBJECTIVE: We developed a new mobile, rapid CRP measurement device using a gold-linked electrochemical immunoassay (GLEIA) system. The aim of this study was to evaluate the feasibility of this mobile CRP-testing device. METHODS: First, we assessed the performance of bare GLEIA-based electrode chips as the foundation of the device. After embedding the bare GLEIA-based electrode chips in a special plastic case and developing the mobile CRP-testing device, we further tested the device prototype using clinical blood samples. Finally, we evaluated the intra-assay variability for precision in the same condition and inter-assay variability for reproducibility in different conditions. RESULTS: Blood samples for analysis were obtained by direct vein puncture from outpatients (N=85; females: 57/85; males: 28/85; age: 19-88 years) at Kanazawa University Hospital in Japan. For performance evaluation of bare GLEIA-based electrode chips, we used 85 clinical blood samples. There was a significant positive correlation between the electrode-predicted CRP levels and the reference CRP concentrations (R(2)=0.947; P<.001). The assembled device was mobile (size 45×90×2.4 mm; weight 10 g) and disposable. The minimum volume of the sample needed for measuring CRP was 1.4 µL. The estimated preanalytical time was approximately 7 minutes and 40 seconds, and analysis time was approximately 1 minute and 10 seconds. Subsequently, for performance evaluation of the mobile CRP-testing device using GLEIA-based electrode chips, we used 26 clinical blood samples and found a significant positive correlation between the mobile device-predicted CRP levels and the reference CRP concentrations (R(2)=0.866, P<.001). The intra-assay variabilities were 34.2%, 40.8%, and 24.5% for low, medium, and high CRP concentrations, respectively. The inter-assay variabilities were 46.5%, 38.3%, and 64.1% for low, medium, and high CRP concentrations, respectively. CONCLUSIONS: Our findings suggest that this new mobile CRP-testing device might be suitable for use in home-based care settings.
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spelling pubmed-75065392020-10-05 Feasibility of a Novel Mobile C-Reactive Protein–Testing Device Using Gold-Linked Electrochemical Immunoassay: Clinical Performance Study Gondoh-Noda, Yuko Kometani, Mitsuhiro Nomura, Akihiro Aono, Daisuke Karashima, Shigehiro Ushijima, Hiromi Tamiya, Eiichi Murayama, Toshinori Yoneda, Takashi JMIR Mhealth Uhealth Original Paper BACKGROUND: Home-based care is one of the most promising solutions to provide sufficient medical care for several older patients in Japan. However, because of insufficient diagnostic devices, it is sometimes difficult to detect early signs of the occurrence or worsening of diseases, such as infections under home-based care settings. C-reactive protein (CRP) is highly sensitive to diagnosing infections, and its elevation can help diagnose acute infection in older patients. Therefore, a CRP-measuring device that can be used in such a specific occasion is needed for home-based care. However, aspects such as its size, weight, and procedure are still challenging with respect to the practical use of mobile devices that quantitatively measure CRP levels easily and quickly under home-based care settings. OBJECTIVE: We developed a new mobile, rapid CRP measurement device using a gold-linked electrochemical immunoassay (GLEIA) system. The aim of this study was to evaluate the feasibility of this mobile CRP-testing device. METHODS: First, we assessed the performance of bare GLEIA-based electrode chips as the foundation of the device. After embedding the bare GLEIA-based electrode chips in a special plastic case and developing the mobile CRP-testing device, we further tested the device prototype using clinical blood samples. Finally, we evaluated the intra-assay variability for precision in the same condition and inter-assay variability for reproducibility in different conditions. RESULTS: Blood samples for analysis were obtained by direct vein puncture from outpatients (N=85; females: 57/85; males: 28/85; age: 19-88 years) at Kanazawa University Hospital in Japan. For performance evaluation of bare GLEIA-based electrode chips, we used 85 clinical blood samples. There was a significant positive correlation between the electrode-predicted CRP levels and the reference CRP concentrations (R(2)=0.947; P<.001). The assembled device was mobile (size 45×90×2.4 mm; weight 10 g) and disposable. The minimum volume of the sample needed for measuring CRP was 1.4 µL. The estimated preanalytical time was approximately 7 minutes and 40 seconds, and analysis time was approximately 1 minute and 10 seconds. Subsequently, for performance evaluation of the mobile CRP-testing device using GLEIA-based electrode chips, we used 26 clinical blood samples and found a significant positive correlation between the mobile device-predicted CRP levels and the reference CRP concentrations (R(2)=0.866, P<.001). The intra-assay variabilities were 34.2%, 40.8%, and 24.5% for low, medium, and high CRP concentrations, respectively. The inter-assay variabilities were 46.5%, 38.3%, and 64.1% for low, medium, and high CRP concentrations, respectively. CONCLUSIONS: Our findings suggest that this new mobile CRP-testing device might be suitable for use in home-based care settings. JMIR Publications 2020-09-07 /pmc/articles/PMC7506539/ /pubmed/32894233 http://dx.doi.org/10.2196/18782 Text en ©Yuko Gondoh-Noda, Mitsuhiro Kometani, Akihiro Nomura, Daisuke Aono, Shigehiro Karashima, Hiromi Ushijima, Eiichi Tamiya, Toshinori Murayama, Takashi Yoneda. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 07.09.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Gondoh-Noda, Yuko
Kometani, Mitsuhiro
Nomura, Akihiro
Aono, Daisuke
Karashima, Shigehiro
Ushijima, Hiromi
Tamiya, Eiichi
Murayama, Toshinori
Yoneda, Takashi
Feasibility of a Novel Mobile C-Reactive Protein–Testing Device Using Gold-Linked Electrochemical Immunoassay: Clinical Performance Study
title Feasibility of a Novel Mobile C-Reactive Protein–Testing Device Using Gold-Linked Electrochemical Immunoassay: Clinical Performance Study
title_full Feasibility of a Novel Mobile C-Reactive Protein–Testing Device Using Gold-Linked Electrochemical Immunoassay: Clinical Performance Study
title_fullStr Feasibility of a Novel Mobile C-Reactive Protein–Testing Device Using Gold-Linked Electrochemical Immunoassay: Clinical Performance Study
title_full_unstemmed Feasibility of a Novel Mobile C-Reactive Protein–Testing Device Using Gold-Linked Electrochemical Immunoassay: Clinical Performance Study
title_short Feasibility of a Novel Mobile C-Reactive Protein–Testing Device Using Gold-Linked Electrochemical Immunoassay: Clinical Performance Study
title_sort feasibility of a novel mobile c-reactive protein–testing device using gold-linked electrochemical immunoassay: clinical performance study
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7506539/
https://www.ncbi.nlm.nih.gov/pubmed/32894233
http://dx.doi.org/10.2196/18782
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