Comparative study of i-SENS glucometers in neonates using capillary blood samples
- Authors
- Kim, H.N.; Yoon, S.-Y.
- Issue Date
- 5월-2021
- Publisher
- De Gruyter Open Ltd
- Keywords
- Capillary blood glucose levels; Hypoglycemia; I-sens glucometers; Neonatal care; Neonates; Point-of care blood glucometers
- Citation
- Clinical Chemistry and Laboratory Medicine, v.59, no.6, pp.1133 - 1141
- Indexed
- SCIE
SCOPUS
- Journal Title
- Clinical Chemistry and Laboratory Medicine
- Volume
- 59
- Number
- 6
- Start Page
- 1133
- End Page
- 1141
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/128902
- DOI
- 10.1515/cclm-2020-1367
- ISSN
- 1434-6621
- 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. © 2021 De Gruyter. All rights reserved.
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