Analytic Performance Evaluation of Blood Monitoring System G400 according to ISO 15197:2013

Doheun Chung; Byungkeun Choi; Byungwook Yoo; Chooyon Cho; Sungho Hong; Jungeun Oh; Yongjin Cho

doi:10.15384/kjhp.2016.16.4.223

Korean J Health Promot > Volume 16(4); 2016 > Article

Chung, Choi, Yoo, Cho, Hong, Oh, and Cho: Analytic Performance Evaluation of Blood Monitoring System G400 according to ISO 15197:2013

Original Article

Korean Journal of Health Promotion 2016;16(4):223-230.

Published online: January 20, 2016

DOI: https://doi.org/10.15384/kjhp.2016.16.4.223

Analytic Performance Evaluation of Blood Monitoring System G400 according to ISO 15197:2013

Department of Family Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea

Doheun Chung, Byungkeun Choi, Byungwook Yoo, Chooyon Cho, Sungho Hong, Jungeun Oh, Yongjin Cho

Corresponding author: Byungwook Yoo, MD, PhD Department of Family Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, 59 Daesagwan-ro, Yongsan-gu, Seoul 04401, Korea
Tel: +82-2-709-9133, Fax: +82-2-795-3687 E-mail: dryoo@schmc.ac.kr

Received September 02, 2016 Accepted October 11, 2016

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.

요약

Background

Self-monitoring of blood glucose is an important component of therapy for diabetes mellitus. The aim of this study was to evaluate the analytic performance evaluation of blood monitoring system G400 according to ISO 15197:2013.

Methods

We evaluated the G400 according to the ISO 15197:2013 guideline, we measured precision, accuracy, interference of hematocrit and interfering substances, user performance.

Results

Repeatability and intermediate precision of G400 showed standard deviation 2.7–3.8 mg/dL, 2.4–3.6 mg/dL and coefficient of variation 1.9–2.9% and 1.7–3.7%, respectively. Accuracy measured 98–98.5%, satisfied acceptable criteria. Error grid analysis showed that all results of this study were in zone A. Hematocrit between 20% to 60% did not cause interference. Three of 24 interfering substances were not acceptable criteria, and dose-response evaluation was needed.

Conclusions

This study showed that G400 was considered reliable results satisfying the ISO 15197:2013 criteria

Keywords: ISO 15197:2013, Blood glucose self-monitoring, Diabetes mellitus, G400S

Figure 1.

Accuracy of G400. (A) Consensus Error grids of each lots. (B) Accuracy plot of each lots.

Figure 2.

Interference of hematocrit. The two bold lines represent the acceptance criteria: ±10 mg/dL of the results at glucose concentrations <100 mg/dL, ±10% of the results at glucose concentrations ≥100 mg/dL. Interval 1 is 30–50 mg/dL, interval 2 is 96–144 mg/dL, interval 3 is 280–420 mg/dL.

Figure 3.

Dose-response evaluation.

Figure 4.

User performance. (A) Consensus error grid. (B) Accuracy plot.

Table 1.

Repeatability of G400

YSI 2300 STAT PLUS, mg/dL	Lot 1			Lot 2			Lot 3			YSI 2300 STAT PLUS last mean, mg/dL	YSI 2300 STAT PLUS differ % or mg/dL	Grand mean, mg/dL	Pooled SD or CV
YSI 2300 STAT PLUS, mg/dL	Mean	SD	CV	Mean	SD	CV	Mean	SD	CV	YSI 2300 STAT PLUS last mean, mg/dL	YSI 2300 STAT PLUS differ % or mg/dL	Grand mean, mg/dL	Pooled SD or CV
41.5	42.3	3.1	–^a	39.3	3.3	–	40.5	3.7	–	39.5	2.0 mg/dL	40.7	3.6 mg/dL
99.2	95.3	3.8	–	93.3	2.7	–	90.8	3.8	–	98.4	0.9 mg/dL	93.1	3.9 mg/dL
138	131.6	3.4	2.6	130.9	3.2	2.4	132.0	3.8	2.9	135.5	1.8%	131.5	2.7%
206	194.4	4.6	2.3	195.2	4.3	2.2	193.9	5.4	2.8	202.0	1.9%	194.5	2.5%
281	272.0	5.5	2.0	270.0	5.1	1.9	272.4	5.6	2.1	277.0	1.4%	271.5	2.0%

Abbreviations: SD, standard deviation; CV, coefficient of variation. Values are presented as mean (mg/dL), SD (mg/dL) or CV (%).

^aAcceptance criteria: <100 mg/dL: SD less than 5 mg/dL, ≥100 mg/dL: CV less than 5%.

Table 2.

Intermediate precision of G400

	Interval	Lot 1			Lot 2			Lot 3			Pooled SD or CV
	Interval	Mean	SD	CV	Mean	SD	CV	Mean	SD	CV	Pooled SD or CV
User 1
	30–50	42.6	3.1	–^a	43.5	2.8	–	44.1	2.5	–	2.8 mg/dL
	96–144	120.2	3.9	3.3	119.9	3.6	3.0	120.1	4.4	3.6	3.3%
	280–420	365.2	8.6	2.4	365.6	8.8	2.4	370.1	8.6	2.3	2.4%
User 2
	30–50	45.7	3.4	–	46.1	2.4	–	45.7	2.8	–	2.9 mg/dL
	96–144	125.0	3.6	2.9	124.7	2.9	2.3	124	2.7	2.2	2.5%
	280–420	379.6	7.7	2.0	384.7	6.6	1.7	365.5	7.1	1.9	1.9%
Combined result
	30–50	44.1	3.6	–	44.8	2.9	–	44.9	2.8	–	3.1 mg/dL
	96–144	122.6	4.5	3.7	122.3	4.1	3.3	122.0	4.1	3.4	3.5%
	280–420	372.4	10.9	2.9	375.1	12.3	3.3	367.8	8.2	2.2	2.8%

Abbreviations: SD, standard deviation; CV, coefficient of variation. Values are presented as interval (mg/dL), mean (mg/dL), SD (mg/dL) or CV (%).

^aAcceptance criteria: <100 mg/dL: SD less than 5 mg/dL, ≥100 mg/dL: CV less than 5%.

Table 3.

System accuracy results for glucose concentrations

Lot. number	±15 mg/dL (<100 mg/dL) or			±10 mg/dL (<100 mg/dL) or			±5 mg/dL (<100 mg/dL) or			Result
Lot. number	15%(≥100 mg/dL)			10% (≥100 mg/dL)			5%(≥100 mg/dL)			Result
Total	590		600	553		600	391		600	Pass
Total		98.3%			92.1%			65.1%		Pass
Lot. 1	196		200	184		200	134		200	Pass
Lot. 1		98.0%			92.0%			67.0%		Pass
Lot. 2	197		200	185		200	129		200	Pass
Lot. 2		98.5%			92.5%			64.5%		Pass
Lot. 3	197		200	184		200	128		200	Pass
		98.5%			92.0%			64.0%

Table 4.

Interference of hematocrit

Diff. % (Hct 40%)			Lot 1					Lot 2					Lot 3
Hct, %	20	30	40	50	60	20	30	40	50	60	20	30	40	50	60
30‐50 mg/dL, mg/dL	‐8.1	‐4.2	0.0	6.2	7.0	‐5.2	‐3.5	0.0	7.7	8.5	‐6.9	‐4.1	0.0	7.2	8.3
96‐144 mg/dL, %	1.1	‐0.1	0.0	0.5	1.7	1.2	0.4	0.0	2.3	2.7	0.5	1.1	0.0	2.4	2.0
280‐420 mg/dL, %	9.3	4.7	0.0	‐4.8	‐5.2	6.7	5.4	0.0	‐3.6	‐5.9	7.8	6.3	0.0	‐3.9	‐5.6

Table 5.

Interference testing possible interfering

Interfering substances		Interfering substances	Glucose	Lot 1	Lot 2	Lot 3	Average	Acceptable	Results
Interfering substances		concentration	concentration	Lot 1	Lot 2	Lot 3	Average	criteria	Results
1	Acetaminophen	20 mg/dL	Low	4.1	3.8	4.6	4.2	<10 mg/dL	Pass
			High	0.1	0.6	–0.9	–0.1	<10%	Pass
2	Ascorbate	3 mg/dL	Low	3.7	3.1	3.5	3.4	<10 mg/dL	Pass
			High	4.6	3.7	4.9	4.4	<10%	Pass
3	Bilirubin	20 mg/dL	Low	4.3	4.0	6.7	5.0	<10 mg/dL	Pass
			High	5.3	5.3	4.4	5.0	<10%	Pass
4	Cholesterol	310 mg/dL	Low	–6.8	–5.3	–6.3	–6.1	<10 mg/dL	Pass
			High	–2.9	–2.5	–3.4	–2.9	<10%	Pass
5	Creatinine	10 mg/dL	Low	0.3	0.4	0.9	0.5	<10 mg/dL	Pass
			High	–1.1	–0.6	–0.3	–0.7	<10%	Pass
6	EDTA	200 mg/dL	Low	–3.4	–1.3	–7.0	–3.9	<10 mg/dL	Pass
			High	1.0	1.2	0.7	1.0	<10%	Pass
7	Galactose	10 mg/dL	Low	1.1	0.9	2.0	1.3	<10 mg/dL	Pass
			High	0.9	0.1	–0.3	0.2	<10%	Pass
8	Glutathinone	100 μmol/L	Low	–1.2	–0.3	–0.8	–0.8	<10 mg/dL	Pass
			High	1.8	3.0	2.4	2.4	<10%	Pass
9	Hemoglobin	15,200 mg/dL	Low	–4.4	–3.6	–5.0	–4.3	<10 mg/dL	Pass
			High	–0.2	–1.5	–1.1	–0.9	<10%	Pass
10	Heparin	5,100 U/dL	Low	3.0	3.6	3.6	3.4	<10 mg/dL	Pass
			High	–1.7	–2.3	–2.5	–2.2	<10%	Pass
11	Ibuprofen	50 mg/dL	Low	1.6	1.9	2.1	1.9	<10 mg/dL	Pass
			High	5.5	5.1	6.9	5.8	<10%	Pass
12	Icodextrin	460 mg/dL	Low	–3.4	–2.2	–2.5	–2.7	<10 mg/dL	Pass
			High	–3.1	–2.2	–3.3	–2.9	<10%	Pass
13	Pralidoxime iodide	10 mg/dL	Low	0.5	0.2	0.9	0.5	<10 mg/dL	Pass
			High	–0.5	–0.2	–0.1	–0.3	<10%	Pass
14	L-DOPA	5 μg/mL	Low	4.4	4.5	6.6	5.2	<10 mg/dL	Pass
			High	2.3	3.0	2.9	2.7	<10%	Pass
15	Maltose	500 mg/dL	Low	–6.1	–4.4	–4.9	–5.1	<10 mg/dL	Pass
			High	–1.2	–2.8	–1.8	–1.9	<10%	Pass
16	Methyl-DOPA	1.5 mg/dL	Low	5.5	5.6	6.5	5.9	<10 mg/dL	Pass
			High	6.2	6.0	6.2	6.1	<10%	Pass
17	Salicylate	50 mg/dL	Low	–3.0	–1.9	–1.6	–2.2	<10 mg/dL	Pass
			High	–0.6	–0.8	–0.5	–0.6	<10%	Pass
18	Tolbutamide	100 mg/dL	Low	–7.3	–4.3	–5.8	–5.8	<10 mg/dL	Pass
			High	0.4	0.6	0.2	0.4	<10%	Pass
19	Triglycerides	500 mg/dL	Low	–4.1	–3.7	–2.9	–3.6	<10 mg/dL	Pass
			High	–0.9	–1.7	–2.4	–1.7	<10%	Pass
20	Urate	10 mg/dL	Low	7.1	7.3	8.1	7.5	<10 mg/dL	Pass
			High	3.4	3.0	3.6	3.3	<10%	Pass
21	Xylose	200 mg/dL	Low	9.9	9.8	9.6	9.8	<10 mg/dL	Pass
			High	–0.5	–3.6	–6.4	–3.5	<10%	Pass
22	Dopamine	3 mg/dL	Low	14.3	14.2	13.1	13.9	<10 mg/dL	Fail
			High	3.8	4.3	4.6	4.2	<10%	Pass
23	Gentisic acid	50 mg/dL	Low	85.6	84.6	82.7	84.3	<10 mg/dL	Fail
			High	6.4	7.9	7.4	7.2	<10%	Pass
24	Tolazamide	40 mg/dL	Low	40.4	39.0	41.5	40.3	<10 mg/dL	Fail
			High	11.4	12.4	11.1	11.6	<10%	Fail

Abbreviations: EDTA, ethylenediaminetetraacetic acid; DOPA, 3, 4-dihydroxyphenylalanine.

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