Nonenzymatic glucose detection using Au nanodots decorated Cu2O nanooctahedrons

2021 ◽  
Vol 11 ◽  
pp. 184798042110128
Author(s):  
Dexiang Chen ◽  
Kaifeng Xue ◽  
Huaiqiang Liu ◽  
Binbin Yao ◽  
Aixin Sun ◽  
...  
Keyword(s):  
High Performance ◽  
Glucose Monitoring ◽  
Rapid Test ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Commercial Application ◽  
Galvanic Replacement ◽  
Detection Accuracy ◽  
Glucose Detection ◽  
Au Nanodots

Au nanodots decorated Cu2O nanooctahedrons were fabricated by a facile liquid-phase process combined with a galvanic replacement reaction for nonenzyme glucose detection. A simple rapid test strip based on the nanooctahedrons was proposed to evaluate the possibility of commercial application in nonenzymatic glucose detection. This test strip shows excellent response toward glucose. Linear response was obtained over a concentration ranging from 0.05 mM to 15 mM, and the detection accuracy is 0.05 mM. The good detection performance in selectivity, stability, and feasibility proving the great potential application in human blood glucose monitoring. This study demonstrated the possibility of a high-performance nonenzyme glucose test strip based on metal-oxide nanostructures decorated by catalysts.

scholarly journals Solvothermal synthesis of Fe3O4 nanospheres for high-performance electrochemical non-enzymatic glucose sensor

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Jiasheng Xu ◽  
Yuting Sun ◽  
Jie Zhang
Keyword(s):  
Active Sites ◽  
High Performance ◽  
Glucose Sensor ◽  
Limit Of Detection ◽  
Glucose Monitoring ◽  
High Sensitivity ◽  
Blood Glucose Monitoring ◽  
Glucose Detection ◽  
Uniform Size ◽  
Long Term Stability

Abstract Ferroferric oxide (Fe3O4) nanospheres have been synthesized via a facile solvothermal procedure to serve as an electrode material for high performance non-enzymatic glucose sensor. The as-synthesized Fe3O4 nanospheres with a uniform size from 16 to 18 nm, which can increase the reaction contact area and the active sites in the process of glucose detection. Benefiting from the particular nanoscale structure, the Fe3O4 nanospheres obviously enhanced the activity of electrocatalytic oxidation towards glucose. When the Fe3O4 nanospheres material was used for non-enzymatic glucose sensor, several electrochemical properties including the high sensitivity 6560 μA mM−1 cm−2 (0.1–1.1 mM), limit of detection 33 μM (S/N = 3) and good long-term stability were well demonstrated. Furthermore, Fe3O4 nanospheres electrode confirmed the excellent performance of selectivity in glucose detection with the interfering substances existed such as urea, citric acid, ascorbic acid, and NaCl. Due to the excellent electrocatalytic activity in alkaline solution, the Fe3O4 nanospheres material can be considered as a promising candidate in blood glucose monitoring.

867-P: Ongoing Manufacturer-Led Clinical Surveillance of Two Blood Glucose Monitoring Test Strip Systems

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 867-P
Author(s):  
STEVEN J. SETFORD ◽  
LAURENCE B. KATZ ◽  
MIKE GRADY ◽  
KIRSTY MACLEOD ◽  
HILARY CAMERON
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Monitoring Test ◽  
Clinical Surveillance

Performance of a New Test Strip for FreeStyle Blood Glucose Monitoring Systems

2011 ◽  
Vol 13 (1) ◽  
pp. 1-10 ◽  
Author(s):  
John Paul Lock ◽  
Ronald Brazg ◽  
Robert M. Bernstein ◽  
Elizabeth Taylor ◽  
Mona Patel ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems

scholarly journals Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision

2018 ◽  
Vol 13 (1) ◽  
pp. 111-117 ◽  
Author(s):  
Stefan Pleus ◽  
Nina Jendrike ◽  
Annette Baumstark ◽  
Jochen Mende ◽  
Cornelia Haug ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Measurement Precision ◽  
Blood Glucose Monitoring ◽  
Monitoring Systems ◽  
Analytical Quality ◽  
Acceptance Criteria ◽  
Accuracy Measurement ◽  
Measurement Repeatability

Introduction: Blood glucose monitoring systems (BGMS) should provide sufficient analytical quality to allow adequate therapy for diabetes patients. Besides system accuracy, measurement precision is an important aspect of a BGMS’ analytical quality. Methods: Based on ISO 15197:2013/EN ISO 15197:2015, system accuracy, measurement repeatability, and intermediate measurement precision were assessed. ISO 15197:2013 system accuracy criteria require that ⩾95% of individual BGMS’ test strip lot results shall fall within ±15 mg/dl or ±15% of corresponding comparison method results (at glucose concentrations <100 mg/dl and ⩾100 mg/dl, respectively), and that ⩾99% of results fall within consensus error grid (CEG) zones A and B. Measurement repeatability was assessed using venous blood samples, whereas intermediate measurement precision was assessed using control solution samples. Standard deviation (SD) and coefficient of variation (CV) were calculated for glucose concentrations <100 mg/dl and ⩾100 mg/dl, respectively. Precision acceptance criteria are not specified by ISO 15197:2013. Results: All three BGMS fulfilled system accuracy criteria with 96% to 98% of individual test strip lot’s results falling within the acceptable accuracy limits. All measurement results fell within CEG zones A and B. For measurement repeatability, SD was ⩽3.3 mg/dl, and CV was ⩽3.9% for the investigated BGMS. Assessment of intermediate measurement precision showed SD ⩽1.3 mg/dl and CV ⩽3.0%. Conclusion: All three BGMS fulfilled system accuracy criteria of ISO 15197:2013. In absence of acceptance criteria, precision results were found to be consistent with the manufacturer’s labeling of the investigated devices.

Assessment of a New Visual Test Strip for Blood Glucose Monitoring

Diabetes Care ◽  
1983 ◽  
Vol 6 (6) ◽  
pp. 543-547 ◽  
Author(s):  
S. M. Marshall ◽  
K. G. M. M. Alberti
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Visual Test

scholarly journals Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance

2021 ◽  
pp. 193229682110394 ◽  
Author(s):  
Steven Setford ◽  
Zuifang Liu ◽  
David McColl ◽  
Stuart Phillips ◽  
Hilary Cameron ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Absolute Difference ◽  
Market Surveillance ◽  
Post Market Surveillance ◽  
Post Market ◽  
Clinical Accuracy ◽  
Improved Algorithm

Background: On-going manufacturer-led post-market surveillance (PMS), assessing the clinical accuracy of blood glucose monitoring (BGM) systems, is critical to substantiate the performance of such products for people with diabetes. Materials and Methods: Batches of Verio test-strip product were randomly and routinely selected over the period from launch of an improved-algorithm product to reporting date and sent to 3 clinic sites for clinician-led accuracy assessment. Accuracy is reported as per recently adopted FDA guidance for BGM systems, EN ISO 15197:2015 and MARD/MAD (Mean absolute relative difference/Mean absolute difference). Results: Thirty-three individual test-strip batches were evaluated corresponding to 506 unique donors. Accuracy performance - FDA: 98.9% of values within ±15% of comparator; ISO: 99.0% within ±15 mg/dL or ±15% at <100 mg/dL (<5.55 mmol/L) or ≥100 mg/dL (≥5.55 mmol/L) glucose, respectively. Overall MARD was 4.19% with a MARD range of 3.54%-5.73% across all test strip batches. Conclusions: This post-market surveillance program demonstrates the new BGM system consistently meets measures of clinical accuracy specified by regulators. This program supports a growing demand by regulators for real-world evidence demonstrating consistent in-market product efficacy as opposed to the current largely passive approach that relies on assessment of reports filed by device users.

Clinical evaluation of a novel test strip technology for blood glucose monitoring: Accuracy at hypoglycaemic glucose levels

2012 ◽  
Vol 98 (3) ◽  
pp. 430-435 ◽  
Author(s):  
Srikanth Bellary ◽  
Hillary Cameron ◽  
Kirsty Macleod ◽  
Michael Malecha ◽  
Krisna Koria ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Clinical Evaluation ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Glucose Levels ◽  
Monitoring Accuracy

scholarly journals Accuracy and User Performance Evaluation of a New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device

2017 ◽  
Vol 11 (4) ◽  
pp. 736-743 ◽  
Author(s):  
Timothy S. Bailey ◽  
Jane F. Wallace ◽  
Scott Pardo ◽  
Mary Ellen Warchal-Windham ◽  
Bern Harrison ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Monitoring System ◽  
Mobile Device ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Section 8 ◽  
Self Testing ◽  
Study Staff ◽  
Smart Mobile

Background: The new Contour®Plus ONE blood glucose monitoring system (BGMS) features an easy-to-use, wireless-enabled blood glucose meter that links to a smart mobile device via Bluetooth® connectivity and can sync with the Contour™ Diabetes app on a smartphone or tablet. Methods: The accuracy of the new BGMS was assessed in 2 studies according to ISO 15197:2013 criteria. In Study 1 (laboratory study), fingertip capillary blood samples from 100 subjects were tested in duplicate using 3 test strip lots. In Study 2 (clinical study), 134 subjects with type 1 or type 2 diabetes enrolled at 2 clinical sites. BGMS results and YSI analyzer (YSI) reference results were compared for fingertip blood obtained by untrained subjects’ self-testing and for study staff–obtained fingertip, subject palm, and venous results. Results: In Study 1, 99.0% (594/600) of combined results for all 3 test strip lots fulfilled ISO 15197:2013 Section 6.3 accuracy criteria. In Study 2, 99.2% (133/134) of subject-obtained capillary fingertip results, 99.2% (133/134) of study staff–obtained fingertip results, 99.2% (125/126) of subject-obtained palm results, and 100% (132/132) of study staff–obtained venous results met ISO 15197:2013 Section 8 accuracy criteria. Moreover, 95.5% (128/134) of subject-obtained fingertip self-test results were within ±10 mg/dl (±0.6 mmol/L) or ±10% of the YSI reference result. Questionnaire results showed that most subjects found the BGMS easy to use. Conclusions: The BGMS exceeded ISO 15197:2013 accuracy criteria both in the laboratory and in a clinical setting when used by untrained subjects with diabetes.

scholarly journals Analysis of a Unique Postmarket Surveillance Dataset That a Glucose Test-Strip Demonstrates no Evidence of Interference and Robust Clinical Accuracy Irrespective of the Prescription Medication Status of a Large Cohort of Patients With Diabetes

2019 ◽  
Vol 15 (1) ◽  
pp. 82-90
Author(s):  
Mike Grady ◽  
Hilary Cameron ◽  
Stuart Phillips ◽  
Gillian Smith ◽  
Steven Setford
Keyword(s):  
Glucose Monitoring ◽  
Prescription Medication ◽  
Test Strip ◽  
Blood Glucose Monitoring ◽  
Clinical Registry ◽  
Specific Test ◽  
Patients With Diabetes ◽  
Clinical Accuracy ◽  
The Impact ◽  
Medication Status

Background: Despite a marked increase in polypharmacy in patients with diabetes there have been no thorough evaluations of the impact of polypharmacy on the accuracy of any current blood glucose monitoring (BGM) system. This study evaluated the accuracy of a BGM test-strip with respect to polypharmacy using a large clinical registry dataset. Methods: Medication profiles were analyzed for 830 subjects (334 with type 1 [T1D] and 496 with type 2 diabetes [T2D]) attending three hospitals. Blood samples were analyzed to determine clinical accuracy of the BGM test-strip compared to a laboratory comparator. Results: Across the 830 subjects, 473 different medications (41 diabetes and 432 nondiabetes) were recorded. Patients took on average 6.5 ( n = 1-23) individual medications and 4 ( n = 1-11) unique classes of medication. Clinical accuracy to EN ISO 15197:2015 criteria was met irrespective of increasing average number of individual medication, categorized from 1 to 4, 5 to 8, 9 to 12, and >12 taken per subject (97.7%, 98.4%, 98.1%, and 98.5%, respectively). Clinical accuracy to EN ISO 15197:2015 criteria was also met across 15 classes of medication using the combined dataset (98.1%; 13 003/13 253). Surveillance error grid analysis showed 98.8% (13 079/13 232) of readings presented no clinical risk. No individual class or combination of medication classes impacted clinical accuracy of the BGM test-strip. Conclusions: This comprehensive analysis for this specific test-strip platform demonstrated no evidence of interference and robust clinical accuracy of this test strip, irrespective of the prescription medication status of patients with diabetes.

Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197

2021 ◽  
pp. 193229682110014
Author(s):  
Guido Freckmann ◽  
Jochen Mende ◽  
Stefan Pleus ◽  
Delia Waldenmaier ◽  
Annette Baumstark ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Evaluation Studies ◽  
Glucose Monitoring ◽  
Test Strip ◽  
Relative Difference ◽  
Blood Glucose Monitoring ◽  
Limits Of Agreement ◽  
Measurement Results ◽  
The Mean

Background: The analytical quality of a blood glucose monitoring system (BGMS) is often assessed according to the requirements described in the international standard ISO 15197. However, the mean absolute relative difference (MARD) is sometimes used as well. This analysis aims at providing empirical data from BGMS evaluation studies conducted according to ISO 15197 and at providing an estimation of how MARD and percentage of measurement results within ISO accuracy limits are related. Methods: Results of 77 system accuracy evaluations conducted according to ISO 15197 were used to calculate MARD between BGMS and a laboratory comparison method’s results (glucose oxidase or hexokinase method). Additionally, bias and 95%-limits of agreement (LoA) using the Bland and Altman method were calculated. Results: MARD results ranged from 2.3% to 20.5%. The lowest MARD of a test strip lot that showed <95% of results within ISO limits was 6.1%. The distribution of MARD results shows that only 3.6% of test strip lots with a MARD equal to or below 7% showed <95% of results within ISO limits (2.2% of all test strip lots). Bias of test strip lots that showed ≥95% of results within the limits ranged from −10.3% to +7.4%. The half-width of the 95%-LoA of test strip lots that showed ≥95% of results within the limits ranged from 4.8% to 24.0%. Conclusion: There is a threshold MARD that may allow an estimate whether ISO 15197 requirements are fulfilled, but this statement cannot be made with certainty.

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