Table 2.
Blood Glucose Monitoring System Accuracy Results
| Accuracy thresholda | 75 mg/dl(4.2 mmol/liter) | 100 mg/dl(5.6 mmol/liter) | 100 mg/dl(5.6 mmol/liter) | 72 mg/dl(4 mmol/liter) | Secondary criteriaoutside of ±15 mg/dl(0.83 mmol/liter)/20%c |
|---|---|---|---|---|---|
| Accuracy criteriabelow / abovethe threshold | Within ±15 mg/dl (0.83 mmol/liter)/20%b | Within ±15 mg/dl (0.83 mmol/liter)/15% | Within ±12 mg/dl (0.67 mmol/liter)/12.5% | Within ±9 mg/dl (0.50 mmol/liter)/12.5% | |
| Optium Xceed | 216/216 (100%) | 216/216 (100%) | 211/216 (98%) | 210/216 (97%) | 0/216 (0.0%) |
| Accu-Chek Performa | 209/214(98%) | 196/214 (92%)d | 185/214 (86%)f | 185/214 (86%)f | 5/214 (2.3%) |
| Contour TS | 212/216 (98%) | 209/216 (97%) | 202/216 (94%) | 201/216 (93%) | 4/216 (1.9%) |
| Nova Max | 201/216 (93%)d,e | 192/216 (89%)e | 179/216 (83%)e | 176/216 (81%)e | 15/216 (6.9%) |
| Nova StatStrip Xpress | 184/185 (99%) | 182/185 (98%) | 172/185 (93%) | 172/185 (93%) | 1/185 (0.5%) |
| OneTouch Ultra2 | 207/214 (97%) | 197/214 (92%)f | 185/214 (86%)f | 182/214 (85%)f | 7/214 (3.3%) |
a
Concentration at move from mg/dl difference to % difference from the reference value. Results are combined for above and below the accuracy threshold stated, as required by ISO 15197.
b
Current ISO and CLSI criteria.
c
A secondary criteria anticipated to be implemented to ensure all results are reported; there is expectation that a limit will be set (e.g., no more than x%, unknown at present).
Shaded areas indicate significant difference from
d
Optium Xceed and Nova StatStrip Xpress;
e
Optium Xceed, Nova StatStrip Xpress, and Contour TS; and
f
Optium Xceed only (p < .0034).