Table 3.
Accuracy Based on ISO Numerical Criteria.
| Glucose meter | Met ISO 2003 criteria | ISO 2003 (%) | 95% CI (%) | Met ISO 2013 criteria | ISO 2013 (%) | 95% CI (%) |
|---|---|---|---|---|---|---|
| Contour Next | Yes | 98.3 | [96.2, 99.2] | Yes | 96.8 | [94.3, 98.2] |
| StatStrip Xpress | Yes | 98.8 | [97.0, 99.6] | Yes | 96.5 | [94.0, 98.0] |
| OneTouch VerioIQ | Yes | 97.7 | [95.4, 98.8] | No | 91.9 | [88.5, 94.4] |
| Accu-Chek Nano | Yes | 97.1 | [94.7, 98.4] | No | 91.0 | [87.5, 93.6] |
| FreeStyle Freedom Lite | Yes | 97.1 | [94.7, 98.4] | No | 92.2 | [88.8, 94.6] |
| Accu-Chek Aviva Plus | Yes | 96.0 | [93.3, 97.6] | No | 91.0 | [87.5, 93.6] |
| FreeStyle Lite | Yes | 98.0 | [95.8, 99.0] | No | 91.9 | [88.5, 94.4] |
| Nova Max | No | 92.5 | [89.2, 94.8] | No | 88.2 | [84.3, 91.2] |
| TRUEresult | No | 82.4 | [78.0, 86.01] | No | 68.2 | [63.1, 72.9] |
| HemoCue Glucose 201 | No | 85.3 | [81.1, 88.6] | No | 67.1 | [61.9, 71.8] |
| OneTouch Ultra2 | No | 80.6 | [76.1, 84.5] | No | 70.2 | [65.2, 74.8] |
| ReliOn Prime | No | 75.4 | [70.6, 79.7] | No | 62.1 | [56.9, 67.1] |
| BREEZE ®2 | No | 74.0 | [69.1, 78.4] | No | 62.4 | [57.2, 67.4] |
| ReliOn Micro | No | 72.3 | [67.3, 76.7] | No | 61.9 | [56.6, 66.8] |
| AgaMatrix PRESTO | No | 74.6 | [69.7, 78.9] | No | 63.3 | [58.1, 68.2] |
| AgaMatrix JAZZ | No | 72.5 | [67.6, 77.0] | No | 60.4 | [55.1, 65.5] |
| SideKick | No | 58.4 | [53.1, 63.5] | No | 49.1 | [43.9, 54.4] |
Meters are listed in order of overall increasing MARD. Samples were not collected according to the ISO methods, so failure to meet the criteria in this study does not mean that the meters are not compliant.