Affiliation:
1. Department of Laboratory Medicine , Korea University Guro Hospital , Seoul , Republic of Korea
Abstract
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.
Funder
Korean Health Technology R&D Project
Ministry of Health & Welfare, Republic of Korea
i-SENS, Inc.
Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea
Subject
Biochemistry, medical,Clinical Biochemistry,General Medicine
Cited by
2 articles.
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