New concept for control material in glucose point-of-care-testing for external quality assessment schemes.

OBJECTIVES: Until now, the external quality assessment (EQA) of glucose point-of-care testing (POCT) has lacked a high quality, suitable and commutable control material to assess measurement accuracy. Here we present a concept for determining the accuracy of glucose measurements, which uses human whole blood and does not require stabilising agents. METHODS: This new generation of quality control samples uses a bead that contains a specific amount of glucose. The bead is then dissolved in a whole blood matrix by the EQA participant immediately before the POCT. We analysed its suitability as an EQA material with respect to its reproducibility, homogeneity and stability, and applied it in an EQA pilot study. The glucose target value was determined using the reference measurement procedure and served as an evaluation criterion for the accuracy of the EQA survey results. RESULTS: The homogeneity and stability of the new control material fulfilled the quality requirements of ISO 17043. Based on the reference measurement value for glucose, the results of the pilot EQA scheme showed a pass rate of 84.6 % for the participating POCT devices. The acceptance limit was a 15 % permitted deviation from the target value according to Rili-BAEK. All of the device collectives deviated from the target value by 0-4.4 % with the exception of one device type, which deviated by 21 %. CONCLUSIONS: The new concept offers, for the first-time, whole blood-based trueness controls for glucose POCT analysis for external quality assurance. The concept does not require the addition of any stabilising reagent and is easy to use.

Portable detection of Salmonella in food of animal origin via Cas12a-RAA combined with an LFS/PGM dual-signaling readout biosensor.

A highly specific and sensitive rapid two-signal assay was developed for the detection of Salmonella typhimurium in foods of animal origin. The invA gene of Salmonella was used as the biorecognition element and recombinase-assisted amplification (RAA) technology for signal amplification. By utilizing the specific recognition and efficient trans-cleavage activity of CRISPR/Cas12a, point-of-care testing (POCT) for S. typhimurium was achieved via lateral flow strips (LFS) and personal glucometer (PGM) biosensors as dual signal readout systems, with sensitivities of 33 CFU/mL and 20 CFU/mL, respectively. Users can select the appropriate test system on the basis of specific application requirements: LFSs are ideal for rapid onsite screening, whereas glucometer biosensors offer precise quantitative determination. This approach simplifies the use of large instruments and overcomes site constraints, demonstrating good accuracy and applicability in animal-derived samples, with significant potential for the detection of other pathogens and for use in restricted environments.

Microvolumetric determination of thrombomodulin based on competitive immunoreaction using a portable glucometer.

A new method of reducing the amount of reagent and sample for determination of thrombomodulin (TM) was developed based on competitive immunoreaction using a portable glucometer (PGM). Two types of nanocomposites, TM protein-modified magnetic nanoparticles (MNPs-TM) and TM antibody-/glucose oxidase-modified gold nanoparticles (Ab-GNPs-GOx), were prepared. Their binding product, MNPs-TM-Ab-GNPs-GOx, in the microvolumetric solution was used to catalyze the oxidation of glucose, leading to a decline of the glucose content. The TM-involved competitive immunoreaction had a negative effect on the generation of MNPs-/GNPs-based nanocomposites and inhibited the catalytic oxidation of glucose. The glucose content difference in the microvolumetric solution, which was revealed by a PGM, was in proportion to the logarithm of the TM concentration from 25 ng mL-1 to 2.5 µg mL-1. The limit of detection was 5.7 ng mL-1. Microvolumetric solution and a PGM were used in the measurement, which overcame some deficiencies of classical methods in chemo/biosensing, for example, special instrument, complicated measurement procedure, and high cost.

Glucometrics utilisation in an urban teaching hospital in ireland: current practice and future aims.

BACKGROUND: Dysglycaemia in hospitalised patients is associated with poorer clinical outcomes, including cardiovascular events, longer hospital stays, and increased risk of mortality. Therefore, glucose monitoring is necessary to achieve best outcomes. AIMS: This audit assesses use of point-of-care (POC) blood glucose (BG) testing in Tallaght University Hospital (TUH) over an 8-day period. It evaluates compliance with international and TUH glucose monitoring protocols and determines frequency of diabetes team consultations for inpatient adults. METHODS: Data from an 8-day period (12/03/2023-19/03/2023) were extracted from the TUH COBAS-IT system and analysed. Invalid tests were excluded. Hyperglycaemia was defined as ≥ 10 mmol/L and hypoglycaemia as ≤ 3.9 mmol/L. Persistent hyperglycaemia was defined as two BG results of ≥ 10 mmol/L. A chart review was conducted on adult patients with persistent hyperglycaemia to assess for HbA1C results, diabetes diagnosis, and diabetes consult. RESULTS: 3,530 valid tests were included and analysed. 674 individual patients had tests done. 1,165 tests (33.00%) were hyperglycaemic and 75 (2.12%) were hypoglycaemic. 68.25% of adults with persistent hyperglycaemia had an HbA1C test performed or documented within three months. 42.71% of inpatient adults with persistent hyperglycaemia and a known diabetes diagnosis received a consult from the diabetes team. CONCLUSION: Increased adherence to hospital protocols for testing HbA1C in adults with persistent hyperglycaemia could improve treatment and clinical outcomes. Increased diabetes team consultation could facilitate appropriate treatment and improve patient outcomes in persistently hyperglycaemic adult patient populations.

NIR-Based Electronic Platform for Glucose Monitoring for the Prevention and Control of Diabetes Mellitus.

The glucose level in the blood is measured through invasive methods, causing discomfort in the patient, loss of sensitivity in the area where the sample is obtained, and healing problems. This article deals with the design, implementation, and evaluation of a device with an ESP-WROOM-32D microcontroller with the application of near-infrared photospectroscopy technology that uses a diode array that transmits between 830 nm and 940 nm to measure glucose levels in the blood. In addition, the system provides a webpage for the monitoring and control of diabetes mellitus for each patient; the webpage is hosted on a local Linux server with a MySQL database. The tests are conducted on 120 people with an age range of 35 to 85 years; each person undergoes two sample collections with the traditional method and two with the non-invasive method. The developed device complies with the ranges established by the American Diabetes Association: presenting a measurement error margin of close to 3% in relation to traditional blood glucose measurement devices. The purpose of the study is to design and evaluate a device that uses non-invasive technology to measure blood glucose levels. This involves constructing a non-invasive glucometer prototype that is then evaluated in a group of participants with diabetes.

A veterinary-calibrated point-of-care glucometer accurately measures blood glucose concentration in dogs and cats.

OBJECTIVE: To determine the clinical and analytical accuracy of a new veterinary-calibrated portable blood glucose monitor (PBGM) compared to a reference laboratory analyzer. ANIMALS: Client-owned dogs (n = 77) and cats (n = 64). METHODS: Peripheral and paired capillary whole-blood glucose concentrations measured via PBGM were compared to plasma glucose concentrations measured via a Cobas c501 reference analyzer (Roche). Analytical accuracy was evaluated with the Spearman rank correlation coefficient, Bland-Altman difference plot analysis, and Deming regression. Clinical accuracy was evaluated with Parkes error grid analysis. Paired peripheral and capillary blood samples were compared with the Wilcoxon matched-pairs signed-rank test. RESULTS: There was a high correlation between PBGM and reference analyzer readings in dogs and cats. Human quality assurance standards (International Organization for Standardization 15197:2013 guidelines) for analytical accuracy were met for 95% of feline peripheral blood samples and 89% of canine samples. Similar veterinary standards (American Society of Veterinary Clinical Pathology guidelines) were met for 89% of canine and 92% of feline peripheral blood glucose measurements. Error grid analysis showed that all peripheral canine and 97% of feline measurements were clinically accurate (zone A). Any altered clinical decision for the remaining feline measurements was expected to minimally impact outcome (zone B). No significant difference was found between peripheral and capillary blood glucose measurements in either species. CLINICAL RELEVANCE: The PBGM produced clinically accurate results and is suitable for use in veterinary and home settings to measure blood glucose.

A cost-effective enzyme kinetics and inhibition model for biochemistry education and research.

Enzyme kinetics and inhibition studies are crucial in biochemistry education and research. Conventional methods often require expensive equipment and reagents, potentially limiting their accessibility in limited resource settings. Our approach sought to develop a cost-effective experimental design for studying enzyme kinetics and inhibition. Lactase was chosen as a protein model and its activity was investigated by measuring glucose production from lactose hydrolysis. In the study, commercially available lactase pills were used as an enzyme source, while milk was used as a substrate. Instead of scientific equipment, glucometers were used to measure lactase activity. Enzyme kinetics were evaluated using Michaelis-Menten and Lineweaver-Burk plots. In the study, the effects of temperature, pH, and inhibitors were also investigated. The results of our study aligned with established enzyme kinetics theories and previous studies. Lactase showed temperature and pH-dependent activity, with decreased activity observed at both low and high extremes. Results also showed that galactose acts as a competitive inhibitor of lactase. The approach presented here offers a cost-effective procedure for studying enzyme kinetics and inhibition. It can act as a valuable tool for educational purposes and for preliminary research in settings with limited resources.

Blood Coagulation-Inspired Fibrin Hydrogel for Portable Detection of Thrombin Based on Personal Glucometer.

As one of the biomarkers of coagulation system-related diseases, the detection of thrombin is of practical importance. Thus, this study developed a portable biosensor based on a personal glucometer for rapid detection of thrombin activity. Fibrinogen was used for the detection of thrombin, and the assay principle was inspired by the blood coagulation process, where thrombin hydrolyzes fibrinogen to produce a fibrin hydrogel, and the amount of invertase encapsulated in the fibrin hydrogel fluctuates in accordance with the activity of thrombin in the sample solution. The quantitative assay is conducted by measuring the amount of unencapsulated invertase available to hydrolyze the substrate sucrose, and the signal readout is recorded using a personal glucometer. A linear detection range of 0-0.8 U/mL of thrombin with a limit of detection of 0.04 U/mL was obtained based on the personal glucometer sensing platform. The results of the selectivity and interference experiments showed that the developed personal glucometer sensing platform is highly selective and accurate for thrombin activity. Finally, the reliability of the portable glucometer method for rapid thrombin detection in serum samples was investigated by measuring the recovery rate, which ranged from 92.8% to 107.7%. In summary, the fibrin hydrogel sensing platform proposed in this study offers a portable and versatile means for detecting thrombin using a personal glucometer. This approach not only simplifies the detection process, but also eliminates the need for large instruments and skilled operators, and substantially reduces detection costs.

Enhancing diabetes therapy adherence: a comprehensive study on glucometer usability for type 2 diabetes patients.

Background: Self-monitoring of blood glucose (SMBG) is a vital practice for type 2 diabetes (T2DM), and glucometers have the potential to improve therapy adherence. However, characteristics of glucometers improving their usability are underexplored. A knowledge gap exists regarding patients under 65, warranting further research for diabetes care improvement. Thus, this study aims to gather insights on glucometer accessibility, by analyzing the case of the Accu-Chek® Instant glucometer by Roche Diabetes Care GmbH. Methods: Starting from a previous study having the objective of investigating devices' features able to improve SMBG in over 65 T2DM patients, using the same device, we enlarged the scale, designing a survey that collected answers from 1145 patients of the Center and South of Italy, both under and over 65. 957 answers were analyzed, according to a threshold of 50% completion of the answers. Results: Our results show the major characteristics presented in Accu-Chek® Instant are appreciated differently between patients under 65 and over 65, and between patients with or without previous experience with a glucometer. Discussions and conclusions: It emerged how Accu-Chek® was perceived as more user-friendly among individuals under 65 compared to those aged 65 and over, where more people had prior experience, indicating how such a glucometer can be particularly helpful for naive patients. The study provides valuable insights to the academic discourse on glucometer features and their influence on therapy adherence.

A Serious Game (MyDiabetic) to Support Children's Education in Type 1 Diabetes Mellitus: Iterative Participatory Co-Design and Feasibility Study.

BACKGROUND: Serious games, which are gaming applications used for purposes beyond entertainment to educate users on, and address, specific issues, may present a timely approach to promote healthy diabetes management behaviors among children with type 1 diabetes mellitus (T1DM). The lasting benefits associated with these serious games encompass improved patient education; enhanced glycemic control; the reinforcement of bonds within the community of people with diabetes; the facilitation of meaningful dialogues with caregivers, especially within the familial setting; and a significant reduction in the economic burdens associated with subsequent complications. OBJECTIVE: This paper primarily aims to provide a detailed overview of the iterative design process and the associated evaluation methods used in the development of the educational game. Furthermore, this study aims to enhance motivation for sustained and extended engagement with the game over time. The MyDiabetic game design aims to educate children on various aspects, including the connections among food, insulin, and physical activity. Furthermore, it seeks to impart knowledge related to the operation of a glucometer and an insulin pen, as well as more advanced technologies such as administering glucagon, measuring ketoacidosis, and continuous glucose monitoring. METHODS: The co-design methodology was applied, involving interviews, design workshops, and prototype feedback sessions. A combination of several approaches, such as tailoring, observational learning, social and family support, decision-making practice, and reward systems, was used to support children's compliance. Moreover, incorporating the literature, guidelines, and current practices into the design ensured that the game was aligned with established health care pathways and included relevant information and best practices for diabetes management. RESULTS: The game was tested on 32 children in 3 iterations. Positive responses were received from children who tested the game as well as their parents. The game was also presented to 5 schoolmates of children with T1DM who appreciated a better understanding of the disease and the opportunity to support their friends more efficiently in T1DM compensation. The involvement of children and clinicians in participatory co-design contributed to to the game's high acceptance. With regard to the game's impact on education, 1 week of testing revealed an enhancement in educational outcomes. CONCLUSIONS: The game is especially suitable for children newly diagnosed with T1DM because it acquaints them in a fun way with new terminology; for example, they can try to measure glycemia levels in an interactive way. The game also caters to children who still need to develop reading skills by including an audio guide. The guide ensures that children of all literacy levels can benefit from the game's educational content and interactive experiences. The game is available for download on Google Play and the Apple App Store.

Precision and accuracy of a point of care glucometer for detection of hypoglycaemia in horses.

Point-of-care (POC) glucometry is commonly used in horses; however, measurement error with this method when analysing hypoglycaemic samples (<4 mmol/L) is unknown. The objective of this study was to determine the precision and accuracy of glucometry in hypoglycaemic horses in comparison to a laboratory method of glucose measurement (LAB). Repeatability coefficients were 0.47 mmol/L for POC and 0.09 mmol/L for LAB, and coefficients of variation were 10 % and 2.11 %, for the POC and LAB methods, respectively. Systemic bias with the POC method was present, with a mean bias of -0.26 mmol/L (95 % limits of agreement: -0.88 - 0.37) in comparison to LAB, and <70% of measurements were within 20 % of paired LAB results. Prior to use of glucometers, assessment of the diagnostic performance of the equipment is necessary, including determination of acceptable criteria and reference ranges for hypoglycaemic samples.

Reliability and accuracy of bedside capillary blood glucose measurement by glucometers compared to venous blood glucose in critically ill patients: A facility based cross-sectional study.

BACKGROUND: The traditional reference standard, venous blood glucose requires venipuncture and laboratories usually return the test results after 60 min. Our aim was to determine the agreement accuracy of glucose (capillary) levels obtained by POC glucometers with glucose (venous) values by standard laboratory method (glucose-oxidase) and to assess whether and to what extent the glucometers perform uniformly well across the entire range of blood glucose values. METHODS: We compared the diagnostic accuracy of two-point of care glucometers with laboratory venous glucose, the reference standard using Bland-Altman plots and Clark error grid method to analyse the results. RESULTS: This study included a total of 110 patients (38[34 %] women; mean age 52.1 years (SD, 17.3); range 14-85 years. Fourteen patients (12 %) were known to have diabetes. The mean glucose value (glucometer 1) was 152.9 mg/dL (SD 83.1); range = 48-501 mg/dL; that by glucometer 2 was 152.2 mg/dL (SD 76.2); range = 30-458 mg/dL and by the laboratory was 148.6 mg/dL (SD 81.5); range = 52-480 mg/dL. Of the 110 subjects, 2(2 %) had blood glucose below 70 mg/dL; 85(77 %) between 70 and 180 mg/dL and 23(21 %) had blood glucose exceeding 180 mg/dL. The Bland-Altman plot showed a bias of 4 mg% (95%CI -9.8 to +1.1); and the limits of agreement were -63 and + 54 mg%. The area under the receiver operating characteristic curve for the two glucometers was 0.92 and 0.93 respectively. CONCLUSIONS: Point of care glucose, measured by glucometers was in agreement with the venous glucose estimation. Both glucometers were equally accurate and performed uniformly well across the wide range of blood glucose values.

High concordance of blood glucose measurement in cats between a beta prototype glucometer device and a reference laboratory standard in a clinical setting.

OBJECTIVE: The objective of this study was to evaluate the accuracy of a beta prototype version of a new portable blood glucose meter in feline patients. ANIMALS: 60 client-owned cats. METHODS: In this prospective study, 3-mL blood samples were collected from each cat and analyzed in triplicate using a beta prototype device (AlphaTRAK 3 [AT3]) and by a reference lab standard immediately after collection. Accuracy of the AT3 device was determined in accordance with the International Organization of Standardization (ISO) 15197:2013 criteria, including Bland-Altman plotting and consensus error grid analysis. A Passing-Bablok regression analysis was also performed. RESULTS: 96% of feline measurements fell within the ISO accuracy threshold, and 100% of measurements fell within zones A and B of the consensus error grid, meeting the ISO accuracy requirements. There was no significant bias in the data according to the Bland-Altman analysis. Within the full range of glucose concentrations (20 to 750 mg/dL) the correlation coefficient between the AT3 and the reference lab standard was 0.99. There was no significant constant or proportional bias present in the data. CLINICAL RELEVANCE: The AT3 device met the ISO requirements and is accurate for measurement of blood glucose concentrations in cats.

Impedance-based polymer microneedle patch sensor for continuous interstitial fluid glucose monitoring.

Early detection and effective blood glucose control are critical for preventing and managing diabetes-related complications. Conventional glucometers provide point-in-time measurements but are painful and cannot facilitate continuous monitoring. Continuous glucose monitoring systems are comfortable but face challenges in terms of accuracy, cost, and sensor lifespan. This study aimed to develop a microneedle-based sensor patch for minimally invasive, painless, and continuous glucose monitoring in the interstitial fluid to address these limitations. Experimental results confirm painless and minimally invasive penetration of the skin tissue with cylindrical microneedles (3 × 3 array) to a depth of approximately 520 µm with minimal loading. The microneedle sensors fabricated with precision using the complementary metal-oxide semiconductor process were immobilized with glucose oxidase, as confirmed through phase angle analysis. Long-term tests confirmed the effective operation of the sensor for up to seven days. Glucose concentrations determined from the fitted concentration-impedance curves correlated well with those measured using commercial glucometers, indicating the reliability and precision of the microneedle sensor. The flexible and minimally invasive sensor developed in this study facilitates painless and continuous glucose monitoring.

Accuracy of the Nova StatStrip® glucometer in patients undergoing major abdominal surgery: an observational study.

PURPOSE: While the Nova StatStrip® Glucose Hospital Meter System (Nova Biomedical, Waltham, MA, USA) is approved for point-of-care testing (POCT) in critically ill patients, its use during major abdominal surgery has not been evaluated. The purpose of this study was to assess the accuracy of the Nova StatStrip glucometer in patients undergoing major hepatobiliary procedures using the Parkes error grid (ISO15197:2013) and criteria defined by the Clinical and Laboratory Standards Institute (CLSI) POCT12-A3 guideline. METHODS: This study was a post hoc exploratory study of patients participating in a prospective randomized controlled trial on the effects of hyperinsulinemic normoglycemia (HNC) on infectious outcomes after hepatobiliary surgery. Arterial blood samples were collected before surgery and one hour, two hours, and three hours after baseline. Blood glucose levels were analyzed by the Nova StatStrip glucometer and the GEM® PremierTM 5000 blood gas analyzer. Accuracy of the StatStrip glucometer was assessed using the Parkes error grid for type 1 diabetes mellitus (when 99% of samples were within zones A and B on the Parkes error grid and clinical accuracy was acceptable) and the CLSI POCT12-A3 criteria. RESULTS: Blood glucose levels were analyzed in 135 patients, 70 of whom received the HNC. In the Parkes error grid plotted, all samples at all time-points were within zones A and B. The Nova StatStrip glucometer also satisfied CLSI POCT12-A3 criteria at all time-points. CONCLUSION: The Nova StatStrip glucometer was accurate in patients undergoing major upper abdominal surgery, independent of the administration of high-dose insulin therapy. STUDY REGISTRATION: ClinicalTrials.gov (NCT01528189); registered 7 February 2012.

RéSUMé: OBJECTIF: Bien que le système hospitalier de lecture de la glycémie StatStrip® de Nova (Nova Biomedical, Waltham, MA, É.-U.) soit approuvé pour une utilisation au chevet (ou POCT, pour 'Point of Care Testing') chez la patientèle en état critique, son utilisation n'a pas été évaluée en chirurgie abdominale majeure. L'objectif de cette étude était d'évaluer la précision du glucomètre StatStrip de Nova chez la patientèle bénéficiant d'interventions hépatobiliaires majeures à l'aide de la grille d'erreur de Parkes (ISO15197:2013) et des critères définis par la directive POCT12-A3 du Clinical and Laboratory Standards Institute (CLSI). MéTHODE: Il s'agissait d'une étude exploratoire post-hoc auprès de patient·es participant à une étude randomisée contrôlée prospective sur les effets de la normoglycémie hyperinsulinémique (HNC) sur les issues infectieuses après une chirurgie hépatobiliaire. Des échantillons de sang artériel ont été prélevés avant la chirurgie et une heure, deux heures et trois heures après l'échantillon initial. Les taux de glycémie ont été analysés avec le glucomètre StatStrip de Nova et l'analyseur de gaz sanguin GEM® PremierTM 5000. La précision du glucomètre StatStrip a été évaluée à l'aide de la grille d'erreur de Parkes pour le diabète sucré de type 1 (lorsque 99 % des échantillons se trouvaient dans les zones A et B de la grille d'erreur de Parkes et que la précision clinique était acceptable) et des critères POCT12-A3 du CLSI. RéSULTATS: La glycémie a été analysée chez 135 personnes, dont 70 ont reçu une normoglycémie hyperinsulinémique. Dans la grille d'erreur de Parkes tracée, tous les échantillons à tous les points temporels se trouvaient dans les zones A et B. Le glucomètre StatStrip de Nova a également satisfait aux critères POCT12-A3 du CLSI à tous les points temporels. CONCLUSION: Le glucomètre StatStrip de Nova était précis chez la patientèle bénéficiant d'une chirurgie abdominale supérieure majeure, indépendamment de l'administration d'insulinothérapie à forte dose. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT01528189); enregistrée le 7 février 2012.

Comparison of Two Methods for the Measurement of Blood Plasma and Capillary Blood Glucose in Tropical Highland Grassing Dairy Cows.

(1) Background: There is lack of published studies validating specific cow-side glucometers such as Centrivet GK (CVGK). (2) Methods: The aims were (1) to measure and compare the blood glucose concentrations in 52 tropic highland grassing cows by using CVGK and the traditional enzymatic/photometric assay (EPA) in plasma and serum (reference method) and (2) to establish if glucose concentrations obtained via these methods could be affected by several demographic and zootechnical parameters of the dairy herd evaluated. (3) Results: Glucose concentrations were significantly (p = 0.00) affected by the method used for their measurement. The intra-assay coefficient of variation (CV) for glucose concentrations in plasma EPA and for CVGK was 14% for both methods with serum EPA, whereas the inter-assay CV for plasma EPA and CVGK was 8% and 13.7%, respectively, with serum EPA. Pearson correlation coefficient calculations between the reference method in serum and plasma presented a slightly positive significant (p = <0.000) correlation (r = 0.56), whereas there was not a significant (p = 0.413) correlation between serum EPA and CVGK (r = 0.135). The Passing and Bablok regressions were out of the ideal expected values for the slope (ß = 1) and the intercept (α = 0) (11), whereas the Bland-Altman plots showed a bias of 5.29 ± 11.73 (mg/dL) for serum and plasma and 11.01 ± 15.74 (mg/dL) for serum and CVGK. The ROC curve showed no sensitivity in detecting normoglycemic cows (area = 53.7 %, e.d = 12.5 %, p = 0.759) for CVGK when compared to plasma EPA (area = 36.1 %, e.d = 14.2 %, p = 0.256). Plasma EPA exhibited a better but not significant effect in detecting hyperglycemic cows (area = 63.9%, e.d = 14.2%, p = 0.256) when compared to HHD (area = 46.3 %, e.d = 12.5 %, p = 0.759). General glucose concentrations, independently of the method used, were significantly (p = <0.001) greater in young cows when compared to adult and old cows. (4) Conclusions: Glucose concentration measurement in plasma by using EPA or in capillary blood via CVGK were not reliable methods when compared with the reference method.

Combining hybrid nanoflowers with hybridization chain reaction for highly sensitive detection of SARS-CoV-2 nucleocapsid protein.

BACKGROUND: COVID-19 (coronavirus disease 2019) pandemic has had enormous social and economic impacts so far. The nucleocapsid protein (N protein) is highly conserved and is a key antigenic marker for the diagnosis of early SARS-CoV-2 infection. RESULTS: In this study, the N protein was first captured by an aptamer (Aptamer 58) coupled to magnetic beads (MBs), which in turn were bound to another DNA sequence containing the aptamer (Aptamer 48-Initiator). After adding 5'-biotinylated hairpin DNA Amplifier 1 and Amplifier 2 with cohesive ends for complementary hybridization, the Initiator in the Aptamer 48-Initiator began to trigger the hybridization chain reaction (HCR), generating multiple biotin-labeled DNA concatamers. When incubated with synthetic streptavidin-invertase-Ca3(PO4)2 hybrid nanoflower (SICa), DNA concatamers could specifically bind to SICa through biotin-streptavidin interaction with high affinity. After adding sucrose, invertase in SICa hydrolyzed sucrose to glucose, whose concentration could be directly read with a portable glucometer, and its concentration was positively correlated with the amount of captured N protein. The method is highly sensitive with a detection limit as low as 1 pg/mL. SIGNIFICANCE: We believe this study provided a practical solution for the early detection of SARS-CoV-2 infection, and offered a new method for detecting other viruses through different target proteins.

Impact on result interpretation of correct and incorrect selection of veterinary glucometer canine and feline settings.

Veterinary glucometers should be correctly coded for the patient species; however, coding errors occur in clinical settings and the impact of such errors has not been characterized. We compared glucose concentrations in 127 canine and 37 feline samples using both canine and feline settings on a veterinary glucometer (AlphaTrak; Zoetis). All samples were measured first on the canine setting and then measured using the feline setting. Glucose concentration was also measured using a central laboratory biochemical analyzer (Cobas c311; Roche). Three data comparisons for each species were investigated: incorrectly coded glucometer vs. correctly coded glucometer, correctly coded glucometer vs. Cobas c311, and incorrectly coded glucometer vs. Cobas c311. For each comparison, the following analyses were conducted: Spearman rank correlation coefficient, Bland-Altman difference plot analysis, mountain plot analysis, and Deming regression. For clinical context, Clarke error grids were constructed. There was high positive correlation for all comparisons with both species. For all comparisons, mean difference was low (-0.7 to 0.5 mmol/L for canine samples, 1.0-2.0 mmol/L for feline samples). Incorrect glucometer coding resulted in proportional bias for canine samples and positive constant bias for feline samples, and individual differences could be large (-4.44 mmol/L for one dog, 6.16 mmol/L for one cat). Although the glucometer should be used per the manufacturer's recommendation, coding errors are unlikely to have severe adverse clinical consequences for most patients based on error grid analysis.

An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection.

INTRODUCTION: Each year, people with diabetes and their insurers or governments spend billions of dollars on blood glucose monitors and their associated components. These monitors have evolved substantially since their introduction in the 1970s, and manufacturers frequently protect original medical devices and their modifications by applying for and obtaining patent protection. RESEARCH DESIGN AND METHODS: We tracked the product iterations of five widely used blood glucose monitors-manufactured by LifeScan, Dexcom, Abbott, Roche, and Trividia-from information published by the U.S. Food and Drug Administration (FDA), and extracted relevant U.S. patents. RESULTS: We found 384 products made by the five manufacturers of interest, including 130 devices cleared through the 510(k) pathway, 251 approved via the premarket approval (PMA) pathway or via PMA supplements, and three for which de novo requests were granted. We identified 8095 patents potentially relevant to these devices, 2469 (31%) of which were likely to have expired by July 2021. CONCLUSIONS: Manufacturers of blood glucose monitoring systems frequently modified their devices and obtained patent protection related to these device modifications. The therapeutic value of these new modifications should be critically evaluated and balanced against their additional cost. Older glucose monitoring devices that were marketed in decades past are now in the public domain and no longer protected by patents. Newer devices will join them as their patents expire. Increased demand from people with diabetes and the health care system for older, off-patent devices would provide an incentive for the medical device industry to make these devices more widely available, enabling good care at lower cost when such devices are substantially equivalent in effectiveness and safety. In turn, availability and awareness of older, off-patent devices could help stimulate such demand.

Accuracy of Point-of-Care Blood Glucometers in Neonates and Critically Ill Adults.

PURPOSE: Inpatient glycemic management has become a common issue because of the increasing number of hospitalized patients with hyperglycemia. Point-of-care devices can enable timely inpatient glucose monitoring, which may lead to better outcomes. The accuracy of point-of-care testing in various clinical scenarios has been questioned, particularly in neonates and critically ill patients. This study aimed to evaluate the accuracy of the CONTOUR PLUS and CONTOUR PLUS ONE glucometers (new wireless systems that link to a smart mobile device) when used as point-of-care devices for blood glucose monitoring in neonates and critically ill adults in inpatient settings. METHODS: This cross-sectional study was conducted at a medical center in central Taiwan and enrolled patients admitted to the neonatal intensive care unit, sick child room, or respiratory intensive care unit between November 2020 and April 2021. Neonates with suspected infection or abnormal blood coagulation and adults who had abnormal blood coagulation, were pregnant, had received organ transplants, or had undergone massive blood transfusions were excluded. The accuracy of the glucometers was determined based on the following criteria of the International Organization for Standardization (ISO) standard: 15197:2013. FINDINGS: Overall, 114 neonates (mean age, 4.2 days [range, 0-28 days]; 65 boys [57.0%]) and 106 hospitalized critically ill adults (mean age, 68.2 years [range, 27-94 years]; 72 men [67.9%]) were enrolled in this study. The glucose values obtained with each glucometer had good precision, and all findings met the reference criteria of the within-lot results. All measurements of the neonates' venous blood by each glucometer met the accuracy criteria specified by ISO standard 15197:2013. Furthermore, 98.1% and 97.2% of the arterial blood glucose measurements for critically ill adults obtained with CONTOUR PLUS and CONTOUR PLUS ONE met the accuracy criteria, respectively. IMPLICATIONS: Both glucose management systems met the accuracy criteria for venous blood from neonates and arterial blood from critically ill adults. Thus, the use of these 2 point-of-care devices in inpatient settings, including for neonates and critically ill adults, can be recommended to minimize limitations associated with the clinical application of point-of-care testing in glucose management. The wireless connection may play a role in the subsequent development of institution-wide virtual glycemic management under the supervision of a team of endocrinologists.