Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Mar 22, 2020
Date Accepted: Jun 14, 2020
Feasibility of a Novel Mobile C-reactive Protein Testing Device Using a Gold-linked Electrochemical Immunoassay: Clinical Performance Study
ABSTRACT
Background:
Home-based care is one of the most promising solutions to provide sufficient medical care for several elderly patients in Japan. However, because of insufficient diagnostic devices, it is sometimes difficult to detect early signs of the occurrence and/or worsening of diseases, such as infections under home-based care settings. C-reactive protein (CRP) is highly sensitive for 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 and evaluated the feasibility of a new mobile, rapid CRP measurement device using a gold-linked electrochemical immunoassay (GLEIA) system.
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 (n = 85; males: 28; age: 19–88 years) were obtained by direct vein puncture from outpatients at Kanazawa University Hospital, 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 (R2 = 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 pre-analytical 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 (R2 = 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. Clinical Trial: This study was approved by the Ethics Committees of Kanazawa University (no. 2017078).
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