Performance Evaluation of Glucometer Barozen H Based on ISO 15197 Standards

Yeong-Bin Kim; Ji-Young Seo; Soo-Youn Lee; Hyung-Doo Park

doi:10.3343/lmo.2015.5.1.6

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Kim, Seo, Lee, and Park: Performance Evaluation of Glucometer Barozen H Based on ISO 15197 Standards

Original Article

Clinical Chemistry

Laboratory Medicine Online 2015; 5(1): 6-14.

Published online: 1 January 2015

DOI: https://doi.org/10.3343/lmo.2015.5.1.6

Performance Evaluation of Glucometer Barozen H Based on ISO 15197 Standards

Yeong-Bin Kim, M.D.^1,², Ji-Young Seo, M.T.², Soo-Youn Lee, M.D.^1,², Hyung-Doo Park, M.D.^1,²

¹Department of Laboratory Medicine and Genetics, Sungkyunkwan University School of Medicine, Seoul, Korea.

²Department of Laboratory Medicine and Genetics, Samsung Medical Center, Seoul, Korea.

Corresponding author: Hyung-Doo Park. Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 135-710, Korea. Tel: +82-2-3410-0290, Fax: +82-2-3410-2719, nayadoo@hanmail.net

Received 31 January 2014 Revised 9 June 2014 Accepted 10 June 2014

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

We have evaluated the analytical performance of Barozen H (i-SENS Inc. Seoul, Korea), which was developed for glucose testing and can be connected to hospital information network systems.

Methods

We evaluated the precision of ten glucometers based on repeatability and intermediate precision according to the guidelines of the International Standardization Organization (ISO) 15197:2011. The linearity of patient samples was in the range of 30.7-551.2 mg/dL. The accuracy of the results of Barozen H and the correlation of these results and those of the two other glucometers in comparisons with the Modular D reference device (Roche Diagnostics Ltd., Switzerland) were evaluated using 150 capillary blood and venous whole blood samples.

Results

The ranges for the repeatability and intermediate precision of ten Barozen H glucometers were 1.58-4.61% and 2.85-5.48%, respectively. The linearity was expressed by y=0.9681x+2.0791, and the coefficient of determination (R²) was 0.9996. When venous whole blood samples were used, the correlation coefficient (r) was 0.9914. When glucose levels were under 100 mg/dL, 95.2% of Barozen H results were within ±15 mg/dL, and when glucose levels were 100 mg/dL or higher, 97.2% were within ±15%. When capillary blood samples were used, 41.4% (under 100 mg/dL) and 55.4% (100 mg/dL or higher) of Barozen H results were within ±15 mg/dL and ±15%, respectively.

Conclusions

Barozen H provided reliable results and satisfied the ISO15197:2011 criteria when venous whole blood samples were used. It is thought to be clinically useful as a hospital point-of-care glucometer.

Keywords: Barozen H, Glucometer, ISO 15197:2011, Performance evaluation

Figures and Tables

Fig. 1

Linearity results of the three different glucometers (Barozen H and glucometers A and B).

Fig. 2

Correlations between capillary blood glucose concentrations measured with the three point-of-care glucometers and plasma glucose concentration estimated by the reference method (Modular D).

Fig. 3

Correlations between venous whole blood glucose concentrations measured with the three point-of-care glucometers and plasma glucose concentration estimated by the reference method (Modular D).

Table 1

Overall results of repeatability and intermediate precision of Barozen H

	Repeatability					Intermediate precision
Mean (mg/dL)	40.95	72.55	146.03	198.64	316.93	36.99	118.96	338.77
SD (mg/dL)	1.89	2.67	3.91	4.19	5.00	2.03	3.58	9.65
Total CV (%)	4.61	3.68	2.68	2.11	1.58	5.48	3.01	2.85

Table 2

ISO 15197:2011 criteria and patient proportion according to the glucose level measured by the reference device in a correlation study

Glucose level	ISO 15197 criteria	Capillary blood		Venous whole blood
Glucose level	ISO 15197 criteria	No.	Proportion (%)	No.	Proportion (%)
≤50 mg/dL	5%	0	0	8	5
>50-80 mg/dL	15%	6	4	22	15
>80-120 mg/dL	20%	91	61	30	20
>120-200 mg/dL	30%	33	22	45	30
>200-300 mg/dL	15%	14	9	22	15
>300-400 mg/dL	10%	5	3	15	10
>400 mg/dL	5%	1	1	8	5
Total	100%	150	100	150	100

Table 3

Accuracy results of the three different glucometers

Specimen	Device	Glucose level	N	Within ± 15 mg/dL (<100 mg/dL) or ± 15% (≥100 mg/dL)	Proportion (%)
Capillary blood	Barozen H	<100 mg/dL	58	24	41.4
	Barozen H	≥100 mg/dL	92	51	55.4
	Glucometer A	<100 mg/dL	58	28	48.3
	Glucometer A	≥100 mg/dL	92	66	71.7
	Glucometer B	<100 mg/dL	58	37	63.8
	Glucometer B	≥100 mg/dL	92	77	83.7
Venous whole blood	Barozen H	<100 mg/dL	42	40	95.2
	Barozen H	≥100 mg/dL	108	105	97.2
	Glucometer A	<100 mg/dL	42	42	100
	Glucometer A	≥100 mg/dL	108	97	89.8
	Glucometer B	<100 mg/dL	42	38	90.5
	Glucometer B	≥100 mg/dL	108	97	89.8

Notes

This article is available from http://www.labmedonline.org

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