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

Original Article

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

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

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

Received September 02, 2016       Accepted October 11, 2016

Copyright © 2016 The Korean Society of Health Promotion and Disease Prevention

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
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

Key words: 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.
kjhp-16-223f1.tif
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.
kjhp-16-223f2.tif
Figure 3.
Dose-response evaluation.
kjhp-16-223f3.tif
Figure 4.
User performance. (A) Consensus error grid. (B) Accuracy plot.
kjhp-16-223f4.tif
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
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 (%).

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
  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 (%).

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
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%    
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
  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.

REFERENCES
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