Comparative study of i-SENS glucometers in neonates using capillary blood samples
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Ha Nui Kim
Abstract
Objectives
The accuracy of point-of-care blood glucometers in the detection and evaluation of neonatal hypoglycemia is a concern. This study compared the performance of three i-SENS glucometers with that of the YSI 2300 STAT Plus Analyzer, which was used as a reference.
Methods
The leftover neonatal capillary blood samples of 319 patients were used in this study. The evaluation process and accuracy performance criteria were based on the International Organization for Standardization 15197:2013 guidelines. The evaluation involved three i-SENS glucometers (BAROzen H Expert plus, CareSens PRO, and CareSens H Beat) and the ACCU-CHEK® Inform II glucometer.
Results
The accuracy evaluation yielded acceptable results as follows: a) 100 and 100% for BAROzen H Expert plus; 99.8 and 100% for CareSens PRO; 98.7%, and 97.2% for CareSens H Beat glucometers were within the range of ±0.8 mmol/L (15 mg/dL) and ±15% of the average reference values at glucose concentrations <5.55 mmol/L (100 mg/dL) and ≥5.55 mmol/L (100 mg/dL), respectively, and b) all estimated glucose values (100%) were within the zones A and B of Consensus Error Grid for all three i-SENS glucometers. There was good correlation between the glucose values estimated by the glucometers and the reference values (R>0.990).
Conclusions
This study demonstrated that i-SENS glucometers exhibit acceptable performance and can be used as effective point-of-care devices in neonates.
Funding source: Korean Health Technology R&D Project
Funding source: Ministry of Health & Welfare, Republic of Korea
Award Identifier / Grant number: H15C1512
Funding source: i-SENS, Inc.
Funding source: Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea
Award Identifier / Grant number: HR20C0021
Acknowledgments
We would like to thank Editage (www.editage.co.kr) for the English language editing and also i-SENS, Inc., for providing reagents with technical support.
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Research funding: This study was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HR20C0021) and the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (H15C1512) and i-SENS, Inc.
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Author contributions: HK and SY reviewed the literature and conceived the study. SY was involved in protocol development, obtaining ethical approval, patient recruitment and data analysis. HK wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The research related to human use has been complied with all the relevant national regulations, institutional policies and in accordance the tenets of the Helsinki Declaration, and has been approved by Institutional Review Board of Korea University Guro Hospital (IRB No: 2019GR0016).
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© 2021 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorial
- COVID-19: which lessons have we learned?
- Review
- Global FT4 immunoassay standardization: an expert opinion review
- Mini Review
- Mechanism of bilirubin elimination in urine: insights and prospects for neonatal jaundice
- Opinion Paper
- Laboratory medicine in the COVID-19 era: six lessons for the future
- EFLM Paper
- How to meet ISO15189:2012 pre-analytical requirements in clinical laboratories? A consensus document by the EFLM WG-PRE
- General Clinical Chemistry and Laboratory Medicine
- External quality assessment of M-protein diagnostics: a realistic impression of the accuracy and precision of M-protein quantification
- Error simulation modeling to assess the effects of bias and precision on bilirubin measurements used to screen for neonatal hyperbilirubinemia
- NT-proBNP levels in preeclampsia, intrauterine growth restriction as well as in the prediction on an imminent delivery
- Serum N-glycan fingerprint nomogram predicts liver fibrosis: a multicenter study
- Hematology and Coagulation
- Performance of digital morphology analyzer Vision Pro on white blood cell differentials
- Cardiovascular Diseases
- Prognostic implication of elevated cardiac troponin I in patients visiting emergency department without diagnosis of coronary artery disease
- Relationships between renal function variations and relative changes in cardiac troponin T concentrations based on quantile generalized additive models (qgam)
- Diabetes
- Association of hemoglobin H (HbH) disease with hemoglobin A1c and glycated albumin in diabetic and non-diabetic patients
- Comparative study of i-SENS glucometers in neonates using capillary blood samples
- Infectious Diseases
- Evaluation of four commercial, fully automated SARS-CoV-2 antibody tests suggests a revision of the Siemens SARS-CoV-2 IgG assay
- Vitamin-D levels and intensive care unit outcomes of a cohort of critically ill COVID-19 patients
- Does mid-regional pro-adrenomedullin (MR-proADM) improve the sequential organ failure assessment-score (SOFA score) for mortality-prediction in patients with acute infections? Results of a prospective observational study
- Letters to the Editors
- Global FT4 immunoassay standardization. Response to: Kratzsch J et al. Global FT4 immunoassay standardization: an expert opinion review
- Free-thyroxine standardization: waiting for Godot while well serving our patients today
- Prevalence of SARS-CoV-2 antibodies in health care personnel of two acute care hospitals in Linz, Austria
- Pediatric evaluation of clinical specificity and sensitivity of SARS-CoV-2 IgG and IgM serology assays
- Prevention and control of COVID-19 in the penitentiary of Florence
- Pooling for SARS-CoV-2-testing: comparison of three commercially available RT-qPCR kits in an experimental approach
- Very high SARS-CoV-2 load at the emergency department presentation strongly predicts the risk of admission to the intensive care unit and death
- Next-generation sequencing and RT-PCR to identify a 32-day SARS-CoV-2 carrier
- 25-Hydroxyvitamin D concentrations in COVID-19 patients hospitalized in intensive care unit during the first wave and the second wave of the pandemic
- Laboratory findings in a child with SARS-CoV-2 (COVID-19) multisystem inflammatory syndrome
- Discrepant cardiac troponin results in a young woman
- Response to: towards the rational utilization of SARS-CoV-2 serological tests in clinical practice
- Congress Abstract
- 12th National Scientific Congress SPML,29–31 October 2020, Online, Portugal
Artikel in diesem Heft
- Frontmatter
- Editorial
- COVID-19: which lessons have we learned?
- Review
- Global FT4 immunoassay standardization: an expert opinion review
- Mini Review
- Mechanism of bilirubin elimination in urine: insights and prospects for neonatal jaundice
- Opinion Paper
- Laboratory medicine in the COVID-19 era: six lessons for the future
- EFLM Paper
- How to meet ISO15189:2012 pre-analytical requirements in clinical laboratories? A consensus document by the EFLM WG-PRE
- General Clinical Chemistry and Laboratory Medicine
- External quality assessment of M-protein diagnostics: a realistic impression of the accuracy and precision of M-protein quantification
- Error simulation modeling to assess the effects of bias and precision on bilirubin measurements used to screen for neonatal hyperbilirubinemia
- NT-proBNP levels in preeclampsia, intrauterine growth restriction as well as in the prediction on an imminent delivery
- Serum N-glycan fingerprint nomogram predicts liver fibrosis: a multicenter study
- Hematology and Coagulation
- Performance of digital morphology analyzer Vision Pro on white blood cell differentials
- Cardiovascular Diseases
- Prognostic implication of elevated cardiac troponin I in patients visiting emergency department without diagnosis of coronary artery disease
- Relationships between renal function variations and relative changes in cardiac troponin T concentrations based on quantile generalized additive models (qgam)
- Diabetes
- Association of hemoglobin H (HbH) disease with hemoglobin A1c and glycated albumin in diabetic and non-diabetic patients
- Comparative study of i-SENS glucometers in neonates using capillary blood samples
- Infectious Diseases
- Evaluation of four commercial, fully automated SARS-CoV-2 antibody tests suggests a revision of the Siemens SARS-CoV-2 IgG assay
- Vitamin-D levels and intensive care unit outcomes of a cohort of critically ill COVID-19 patients
- Does mid-regional pro-adrenomedullin (MR-proADM) improve the sequential organ failure assessment-score (SOFA score) for mortality-prediction in patients with acute infections? Results of a prospective observational study
- Letters to the Editors
- Global FT4 immunoassay standardization. Response to: Kratzsch J et al. Global FT4 immunoassay standardization: an expert opinion review
- Free-thyroxine standardization: waiting for Godot while well serving our patients today
- Prevalence of SARS-CoV-2 antibodies in health care personnel of two acute care hospitals in Linz, Austria
- Pediatric evaluation of clinical specificity and sensitivity of SARS-CoV-2 IgG and IgM serology assays
- Prevention and control of COVID-19 in the penitentiary of Florence
- Pooling for SARS-CoV-2-testing: comparison of three commercially available RT-qPCR kits in an experimental approach
- Very high SARS-CoV-2 load at the emergency department presentation strongly predicts the risk of admission to the intensive care unit and death
- Next-generation sequencing and RT-PCR to identify a 32-day SARS-CoV-2 carrier
- 25-Hydroxyvitamin D concentrations in COVID-19 patients hospitalized in intensive care unit during the first wave and the second wave of the pandemic
- Laboratory findings in a child with SARS-CoV-2 (COVID-19) multisystem inflammatory syndrome
- Discrepant cardiac troponin results in a young woman
- Response to: towards the rational utilization of SARS-CoV-2 serological tests in clinical practice
- Congress Abstract
- 12th National Scientific Congress SPML,29–31 October 2020, Online, Portugal
