Table 1.
System Accuracy Results for GlucoCheck neo and Element.
| Results within minimum accuracy criteria of |
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|---|---|---|---|---|---|---|
| ISO 15197:2013b |
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| System | Lot | Comparison method | Study date | ISO 15197:2003a | Criterion A | Criterion B |
| GluNeo, tested as GlucoCheck neo | 1 | Cobas c111 | April-May 2013 | 198/200 (99%) | 193/200 (96.5%) | 600/600 (100%) |
| 2 | 195/200 (97.5%) | 190/200 (95%) | ||||
| 3 | 199/200 (99.5%) | 195/200 (97.5%) | ||||
| Element | 1 | Cobas Integra 400 Plus | Oct 2014 | 198/200 (99%) | 195/200 (97.5%) | 600/600 (100%) |
| 2 | 198/200 (99%) | 193/200 (96.5%) | ||||
| 3 | 196/200 (98%) | 191/200 (95.5%) | ||||
a
At least 95% of results of each individual test strip lot have to be within ±15 mg/dl of comparison measurement results at glucose concentrations <75 mg/dl and within ±20% at glucose concentrations ≥75 mg/dl.
b
For criterion A, at least 95% of results of each individual test strip lot have to be within ±15 mg/dl of comparison measurement results at glucose concentrations <100 mg/dl and within ±15% at glucose concentrations ≥100 mg/dl. For criterion B, at least 99% of results of all 3 test strip lots combined have to be within consensus error grid zones A and B.