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

2020 ◽  
Author(s):  
Yuko Gondoh-Noda ◽  
Mitsuhiro Kometani ◽  
Akihiro Nomura ◽  
Daisuke Aono ◽  
Shigehiro Karashima ◽  
...  

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<sup>2</sup>=0.947; <i>P</i>&lt;.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<sup>2</sup>=0.866, <i>P</i>&lt;.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.

10.2196/18782 ◽  
2020 ◽  
Vol 8 (9) ◽  
pp. e18782
Author(s):  
Yuko Gondoh-Noda ◽  
Mitsuhiro Kometani ◽  
Akihiro Nomura ◽  
Daisuke Aono ◽  
Shigehiro Karashima ◽  
...  

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 (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 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 (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.


2016 ◽  
Vol 6 (1) ◽  
pp. 19
Author(s):  
John Hoon Rim ◽  
Hyo-Jun Ahn ◽  
Kwang Kuk Yoon ◽  
Hye Ryun Kim ◽  
Young-Ah Kim ◽  
...  

Author(s):  
Jianping Lu ◽  
Tingting He ◽  
Guiwu Wei ◽  
Jiang Wu ◽  
Cun Wei

The aging trend of China’s population is increasing, and the pension problem is becoming increasingly prominent. The pension mode provided by the government alone can no longer meet the social demand, and the government’s purchase of home-based care services from social organizations has become a new trend. In order to improve the efficiency and quality of pension services, a reasonable performance evaluation model needs to be established. Performance evaluations of home-based elderly-care services purchased by the government are problematic as a result of multiple-attribute group decision-making (MAGDM), as the problems are not single-attribute or single-expert issues. The extended TODIM not only integrates the advantages of cumulative prospect theory (CPT) into a consideration of the psychological factors of DMs, but also retains the superiority of the classical TODIM in relative dominance. The Pythagorean 2-tuple linguistic sets (P2TLSs) could easily depict qualitative assessment information related to the government’s purchase of home-based care services. Thus, in this paper, we extend the TODIM method based on the cumulative prospect theory (CPT) to the Pythagorean 2-tuple linguistic sets (P2TLSs) and propose a Pythagorean 2-tuple linguistic CPT-TODIM (P2TL-CPT-TODIM) method for MAGDM. The P2TL-CPT-TODIM method was proven superior to the classical one through a case study that included a performance evaluation of a home-based elderly-care service purchased by the government. Meanwhile, a comparison with the P2TL-CPT-TODIM method was performed to demonstrate the stability and effectiveness of the designed method.


2014 ◽  
Vol 9 (1) ◽  
pp. 35-43 ◽  
Author(s):  
Hye-Yoon Jeon ◽  
Deok-Hoon Kong ◽  
Su-Hyeon Kim ◽  
In-Bum Suh ◽  
Eun-Taek Han ◽  
...  

Author(s):  
Mary P. Miles ◽  
Erin E. Walker ◽  
Stephen B. Conant ◽  
Shelly P. Hogan ◽  
Jessy R. Kidd

Attenuation of exercise-induced interleukin-6 (IL-6) responses by carbohydrate (CHO) has been demonstrated in studies comparing controlled doses (≥ 0.9 g · kg−1 · h−1) to placebo, but not in studies of voluntary intake. This study sought to determine if attenuation of the IL-6 response during a 32.2-km mountain trail race occurs for high compared to low ad libitum CHO intakes. IL-6, C-reactive protein (CRP), and creatine kinase activity (CK) were analyzed from blood samples collected 12 h pre-, 0, 4, and 24 h post-race. Subjects were grouped into low (n = 14, 0.4 ± 0.1 g · kg−1· h−1) and high (n = 18, 0.8 ± 0.2 g · kg−1 · h−1) CHO intake groups. IL-6 0 h post-race (P < 0.05) was higher in the low (40.2 ± 22.7 pg · mL−1) compared to the high CHO group (32.7 ± 22.1 pg · mL−1). CRP and CK both increased post-race, but no differences were observed between groups. Attenuation of exercise-induced IL-6 is apparent across a range of CHO intakes.


2021 ◽  
Vol 9 ◽  
Author(s):  
Arturo Alejandro Canul-Euan ◽  
Gibran Zúñiga-González ◽  
Janelly Estefania Palacios-Luna ◽  
Rolando Maida-Claros ◽  
Néstor Fabián Díaz ◽  
...  

Background: Extracellular heat-shock proteins (eHsp) are highly conserved molecules that play an important role in inflammatory diseases and have been quantified in plasma from patients with infectious diseases, including sepsis. There is a constant search for dependable biochemical markers that, in combination with conventional methods, could deliver a prompt and reliable diagnosis of early-onset neonatal sepsis.Objective: We sought to assess the level of eHsp-27, eHsp-60, eHsp-70, and tumor necrosis factor-alpha (TNFα) in plasma of healthy neonates at term and infants with early-onset neonatal sepsis.Methods: This study included 34 newborns that were classified as healthy neonates at term (blood samples from the umbilical cord, n = 23) or infants with early-onset neonatal sepsis (blood samples obtained from umbilical artery by standard sterile procedures before starting a systemic antibiotic intervention, n = 11). All blood samples were centrifuged, and the plasma recovered to determine eHsp-27, eHsp-60, eHsp-70, and TNFα levels by ELISA.Results: Our results indicate that the level of eHsp-27 in healthy neonates at term was 0.045 ± 0.024 pg/ml. This value decreased 2.5-fold in infants with early-onset neonate sepsis (0.019 ± 0.006 pg/ml, p = 0.004). In contrast, the levels of eHsp-60 and eHsp-70 in healthy neonates at term were 13.69 ± 5.3 and 4.03 ± 2.6 pg/ml, respectively. These protein levels increased significantly 1.8- and 1.9-fold in the plasma of infants with early-onset neonatal sepsis (p ≤ 0.001). The level of TNFα in healthy neonates at term was 2.94 ± 0.46 pg/ml, with a 3.0-fold increase in infants with early-onset neonatal sepsis (8.96 ± 0.72 pm/ml, p ≤ 0.001). The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of eHsp compared with that of C-reactive protein were 73.3, 60.0, 47.8, and 33.3%, respectively.Conclusion: This study demonstrated a consistent increase of eHsp-60 and eHsp-70 in the plasma of infants diagnosed with early-onset neonatal sepsis. These proteins showed higher sensitivity and specificity than C-reactive protein and blood culture test.


2021 ◽  
Author(s):  
Man Man Niu ◽  
Qi Jiang ◽  
Jin Wei Ruan ◽  
Hui Hui Liu ◽  
Wei Xia Chen ◽  
...  

Abstract Objective Kawasaki disease (KD) is a common childhood vasculitis absent of the specific laboratory definitions, besides a significant elevation in several inflammatory mediators, such as procalcitonin (PCT). However, whether PCT can serve as a useful candidate for differentiating KD from sepsis, and even for predicting incomplete KD, intravenous immunoglobulin (IVIG) nonrespondsiveness and coronary artery abnormalities (CAAs) remains unclear.Methods 254 Chinese KD children were enrolled and divided into 6 subgroups, including complete KD, incomplete KD, IVIG-responsive KD, IVIG-nonresponsive KD, KD with CAAs and KD without CAAs. Blood samples were collected from all subjects within 24-h pre- and 48-h post-IVIG infusion, respectively. PCT, C-reactive protein, sedimentation rate and blood cell counts were detected. In addition, both 261 sepsis children and 251 healthy children sex- and age-matched with KD children were enrolled in the same period.Results (1) PCT experienced the highest increase in sepsis patients before antibiotic therapy, followed by acute KD patients and the healthy controls. (2) The proportion of KD patients with a PCT concentration below 0.25 ng/ml was 11 folds higher than that of sepsis patients. (3) PCT had a sensitivity of 91.7% and a specificity of 30.3% at a cut-off value of >0.15 ng/ml to predict IVIG nonresponsiveness, and the proportion of IVIG-nonresponders with a PCT concentration of 0.25-0.50 ng/ml was 2 folds higher than that of IVIG-responders. Conclusions The PCT concentrations below 0.25 ng/ml may be useful for discriminating KD from sepsis, and moreover, the PCT concentrations of 0.25-0.50 ng/ml may be helpful in predicting IVIG nonresponsiveness.


2020 ◽  
Vol 25 (12) ◽  
Author(s):  
Anne‐Laure Couderc ◽  
Eddy Puchades ◽  
Patrick Villani ◽  
Robin Arcani ◽  
Laure Farnault ◽  
...  

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Yi Jiang ◽  
Subi Abudurexiti ◽  
Meng-Meng An ◽  
Da Cao ◽  
Jie Wei ◽  
...  

AbstractWe aimed to analyse clinical characteristics and identify risk factors predicting all-cause mortality in older patients with severe coronavirus disease 2019 (COVID-19). A total of 281 older patients with severe COVID-19 were categorized into two age groups (60–79 years and ≥ 80 years). Epidemiological, clinical, and laboratory data, and outcome were obtained. Patients aged ≥ 80 years had higher mortality (63.6%) than those aged 60–79 years (33.5%). Anorexia and comorbidities including hypertension, diabetes and COPD, higher levels of lactate dehydrogenase (LDH), osmotic pressure, C-reactive protein, D-dimer, high-sensitivity troponin I and procalcitonin, and higher SOFA scores were more common in patients aged > 80 years than those aged 60–79 years and also more common and higher in non-survivors than survivors. LDH, osmotic pressure, C-reactive protein, D-dimer, high-sensitivity troponin I, and procalcitonin were positively correlated with age and sequential organ failure assessment (SOFA), whereas CD8+ and lymphocyte counts were negatively correlated with age and SOFA. Anorexia, comorbidities including hypertension, diabetes, and chronic obstructive pulmonary disease (COPD), LDH, osmotic pressure, and SOFA were significantly associated with 28-day all-cause mortality. LDH, osmotic pressure and SOFA were valuable for predicting 28-day all-cause mortality, whereas the area under the receiver operating characteristic curve of LDH was the largest, with sensitivity of 86.0% and specificity of 80.8%. Therefore, patients with severe COVID-19 aged ≥ 80 years had worse condition and higher mortality than did those aged 60–79 years, and anorexia and comorbidities including hypertension, diabetes, COPD, elevated plasma osmotic pressure, LDH, and high SOFA were independent risk factors associated with 28-day all-cause mortality in older patients with severe COVID-19. LDH may have the highest predictive value for 28-day all-cause mortality in all examined factors.


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