Table 4.
Accuracy Results of Nine Blood Glucose Systems with an Oxygen Dependency on Measurement Results (as Mentioned in the Manufacturer’s Labeling)a
| DIN EN ISO 15197:2003 | Current draft revision of ISO 15197 | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BG concentration <75 mg/dl | BG concentration ≥75 mg/dl | BG concentration <100 mg/dl | BG concentration ≥100 mg/dl | |||||||||||||
| BG system | Reference method | Within accuracy limits (±15 mg/dl and ±20%) | ±15 mg/dl | ±10 mg/dl | ±5 mg/dl | ±20% | ±15% | ±10% | ±5% | Within accuracy limits (±15 mg/dl and ±15%) | ±15 mg/dl | ±10 mg/dl | ±5 mg/dl | ±15% | ±10% | ±5% |
| n | % | % | % | % | % | % | % | n | % | % | % | % | % | % | ||
| BGStar | GOx | (179/180) | 100 | 93 | 83 | 99 | 96 | 87 | 62 | (175/180) | 98 | 92 | 80 | 97 | 87 | 62 |
| Element | HK | (172/180) | 97 | 90 | 53 | 95 | 83 | 63 | 29 | (153/180) | 90 | 79 | 48 | 83 | 64 | 30 |
| GlucoCheck Comfort | HK | (178/180) | 97 | 87 | 60 | 99 | 95 | 75 | 42 | (171/180) | 96 | 86 | 56 | 95 | 74 | 41 |
| iBGStar | GOx | (173/180) | 100 | 93 | 57 | 95 | 90 | 74 | 36 | (165/180) | 96 | 90 | 52 | 90 | 72 | 35 |
| Omnitest 3 | GOx | (172/180) | 97 | 90 | 70 | 95 | 91 | 79 | 48 | (165/180) | 94 | 86 | 64 | 91 | 79 | 48 |
| OneTouch VITA | GOx | (180/180) | 100 | 100 | 83 | 100 | 99 | 85 | 51 | (178/180) | 98 | 93 | 72 | 99 | 87 | 50 |
| smartLAB genie | GOx | (172/180) | 75 | 36 | 11 | 99 | 98 | 86 | 56 | (170/180) | 84 | 52 | 23 | 98 | 87 | 57 |
| smartLAB global | GOx | (173/180) | 86 | 75 | 43 | 98 | 94 | 80 | 51 | (167/180) | 91 | 85 | 57 | 93 | 79 | 48 |
| WaveSense Jazz | GOx | (178/180) | 100 | 75 | 39 | 99 | 94 | 78 | 45 | (173/180) | 100 | 75 | 38 | 95 | 80 | 47 |
a
180 results from 90 subjects were evaluated. Data of prepared blood samples (BG concentration <50 and ≥400 mg/dl) were excluded. GOx, glucose oxidase; HK, hexokinase.