kjhp Korean Journal of Health Promotion Korean J Health Promot 2234-2141 2093-5676 The Korean Society of Health Promotion and Disease Prevention 10.15384/kjhp.2016.16.4.223 kjhp-16-223 Original Article Analytic Performance Evaluation of Blood Monitoring System G400 according to ISO 15197:2013 ChungDoheun ChoiByungkeun YooByungwook ChoChooyon HongSungho OhJungeun ChoYongjin Department of Family Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea 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 01 2016 20 01 2016 16 4 223 230 02092016 11102016 Copyright © 2016 The Korean Society of Health Promotion and Disease Prevention 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. 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

 ISO 15197:2013 Blood glucose self-monitoring Diabetes mellitus G400S References Kim MH Kim MK Choi BY Shin YJ Educational disparities in the metabolic syndrome in a rapidly changing society–the case of South Korea Int J Epidemiol 200534 6 126673 Huh HJ Park HD Lee SY Kim JW Evaluation of CareSens(R) N glucometer glucose monitoring system J Lab Med Qual Assur 201032 2 22936 Kwon MJ Lee SY Evaluation of GLUCOCARD X-METER glucose monitoring system Korean J Lab Med 200828 1 815 Song SH Park HD Lee HJ Chun SH Park KU Kim JQ Evaluation of Gluchec fine glucometer J Lab Med Qual Assur 200729 1 18794 Lee SY Lee NY Kim JW Evaluation of 6 glucose testing systems Korean J Lab Med 200323 3 1709 Yoo EH Cho HJ Ki CS Lee SY Evaluation of COSMOsensor glucose monitoring system Korean J Lab Med 200626 1 18 The International Organization for Standardization In vitro diagnostic test systems – Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. ISO/TC 212/SC. International Standard ISO 15197 Geneva The International Organization for Standardization 2013 Lee JH Cha YJ Performance evaluation of BAROZEN H, a networking blood glucose monitoring system for medical institutions Lab Med Online 20155 2 6976 Figures and Tables

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

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.

Dose-response evaluation.

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

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
Mean SD CV Mean SD CV Mean SD 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 (%).

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

Intermediate precision of G400

  Interval Lot 1 Lot 2 Lot 3 Pooled SD or CV
  Mean SD CV Mean SD CV Mean SD 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 (%).

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

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

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

Interference testing possible interfering

Interfering substances   Interfering substances Glucose Lot 1 Lot 2 Lot 3 Average Acceptable Results
  concentration concentration criteria
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.