Evidence map›Paper›PMID 32894233›Full record

ArticleJMIR mHealth and uHealth2020

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

Yuko Gondoh-Noda, Mitsuhiro Kometani, Akihiro Nomura, Daisuke Aono, Shigehiro Karashima, Hiromi Ushijima, Eiichi Tamiya, Toshinori Murayama, Takashi Yoneda

Abstract read
In one paragraph

Article in JMIR mHealth and uHealth, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Yuko Gondoh-NodaDepartment of Clinical Development, Kanazawa University Graduate School of Medicine, Kanazawa, Japan.ORCID 0000-0003-2072-7728
Mitsuhiro KometaniDivision of Endocrinology and Hypertension, Department of Cardiovascular and Internal Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.ORCID 0000-0003-0461-3018
Akihiro NomuraDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Innovative Clinical Research Center, Kanazawa University (iCREK), Kanazawa, Japan.ORCID 0000-0001-6647-8240
Daisuke AonoDivision of Endocrinology and Hypertension, Department of Cardiovascular and Internal Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.ORCID 0000-0003-3031-306X
Shigehiro KarashimaDivision of Endocrinology and Hypertension, Department of Cardiovascular and Internal Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.ORCID 0000-0002-4084-9653
Hiromi UshijimaBioDevice Technology Ltd, Nomi, Japan.ORCID 0000-0001-6691-8832
Eiichi TamiyaBioDevice Technology Ltd, Nomi, Japan.ORCID 0000-0002-7646-4827
Toshinori MurayamaInnovative Clinical Research Center, Kanazawa University (iCREK), Kanazawa, Japan.ORCID 0000-0001-9635-357X
Takashi YonedaDivision of Endocrinology and Hypertension, Department of Cardiovascular and Internal Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.ORCID 0000-0002-0921-158X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHome-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.

objectiveWe 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.

methodsFirst, 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.

resultsBlood 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

conclusionsOur findings suggest that this new mobile CRP-testing device might be suitable for use in home-based care settings.

Indexed as

ImmunoassayAdultAgedAged, 80 and overComputers, HandheldC-Reactive ProteinFeasibility StudiesFemaleGoldHumansJapanMaleMiddle AgedReproducibility of ResultsYoung AdultC-Reactive ProteinGoldassayc-reactive proteinCRPdiagnosticgold-linked electrochemical immunoassay (GLEIA)home-based careimmunoassayinfectionmHealthmobile CRP testing device

Identifiers

PMID32894233
PMCPMC7506539

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.