In this study, the B.Braun Omnitest® 3 Blood Glucose Monitoring System (BGMS, Infopia Co, Ltd, Anyang, Republic of Korea) has been evaluated for accuracy in accordance with ISO 15197:2013 standard.1 From October to November in 2015, this BGMS was evaluated at the Hanil General Hospital in a study conducted by the Institutional Review Board (approval KMC-2015-ME-003) and the notified authority. One hundred capillary blood samples measured by the BGMS were compared to plasma-equivalent glucose values of the fingertip blood samples measured by the YSI 2300 STAT Plus™ (YSI Life Sciences, Yellow Springs, OH, USA) glucose analyzer. Three lots of test strips were repeatedly tested by meters complying with ISO 15197:2013, and assessed the comparison of the results with the respective mean values of the reference measurements. Two meters per lot were tested with capillary whole blood collected from a fingertip with lancing device. The order of measurement by the 6 devices was progressive. Tests using the BGMS were performed by a well-trained technician to minimize user errors and interuser variance. This was to allow the assumption that patients can practice consistent testing with the BGMS. Immediately after skin prick on the finger (interval < 5 min), capillary blood was collected into plasma separation tubes. This blood was then centrifuged at 2400 × g for 10 min. Glucose levels were measured by YSI 2300 STAT Plus Auto analyzer in duplicate. The blood glucose concentration levels and quantities manipulated in the evaluation should be in compliance with ISO 15197:2013. It states that samples with glucose concentrations under 50 mg/dL and over 400 mg/dL can be replaced with manipulated blood during the evaluation. Blood samples can be manipulated through decreasing sugar levels by approximately 7 mg/dL each hour in room temperature, and samples of 50 mg/dL glucose concentration can be produced through glycolysis after collecting capillary blood. In the case of glucose concentration exceeding 400 mg/dL, 40 000 mg/dL stock solution was prepared for addition into blood. After setting the target for blood glucose concentration, measurement of the blood glucose concentration of the collected sample was taken. The formula applied then multiplies the difference in blood glucose concentrations (current volume subtracted from target volume), and divided that product by the stock concentration. With the exception of the above, all blood samples have been evaluated utilizing non-manipulated blood. The accuracy criteria of ISO 15197:2013 is that more than 95% of blood glucose measurement values must be within ±mg/dL for the range below 100 mg/dL and ± the range above 100 mg/dL. In this study, this BGMS fulfilled the accuracy criteria (Table 1). At blood glucose (BG) values <100 mg/dL, this BGMS showed 95% to 100% of results within ±15 mg/dL and 81.7% to 90% within ±10 mg/dL. At BG concentrations ≥100 mg/dL, 96.4% to 98.6% of the values measured with this BGMS were within ±15%, and 82.9 to 88.6% within ±10%. Considering all BG concentrations, 97% to 98.5% of results were within the limits. In consensus error grid analysis, the measurement values of each lot were all within zone A, and therefore 100% of reagent system lots were within zone A and zone B.
Table 1.
System Accuracy Between BGMS and YSI 2300 STAT Plus Auto Analyzer (N = 200).
| Strip lot | Accuracy criteria of ISO 15197:2013 |
||||||
|---|---|---|---|---|---|---|---|
| Total |
BG concentration < 100 mg/dL |
BG concentration ≥ 100 mg/dL |
|||||
| Within ±15 mg/dL or 15%, n/N (%) | Within ±15 mg/dL, n/N (%) | Within ±10 mg/dL, n/N (%) | Within ±5 mg/dL, n/N (%) | Within ±15%, n/N (%) | Within ±10%, n/N (%) | Within ±5%, n/N (%) | |
| F2QF03 | 197/200 (98.5) | 60/60 (100.0) | 54/60 (90.0) | 38/60 (63.3) | 137/140 (97.9) | 124/140 (88.6) | 81/140 (57.9) |
| F2QF04 | 195/200 (97.5) | 57/60 (95.0) | 49/60 (81.7) | 30/60 (50.0) | 138/140 (98.6) | 118/140 (84.3) | 65/140 (46.4) |
| F2QF05 | 194/200 (97.0) | 59/60 (98.3) | 49/60 (81.7) | 29/60 (48.3) | 135/140 (96.4) | 116/140 (82.9) | 72/140 (51.4) |
In this study, the performance of this BGMS met ISO 15197:2013 criteria for a self-monitoring glucose meter.
Footnotes
Abbreviations: BG, blood glucose; BGMS, blood glucose monitoring system.
Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.
Reference
- 1. International Organization for Standardization. In vitro diagnostic test systems—Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2013 (E). [Google Scholar]