Table 2.
SMBG System Accuracy Evaluation: Test Procedure Requirements Described in the ISO 15197 Standard in Its 2003 and 2013 Versions.
| ISO 15197:2003 | ISO 15197:2013 | ||||
|---|---|---|---|---|---|
| Number of test strip lots | 1 | 3 | |||
| Performance of measurements with the SMBG system | Laboratory/medical personnela | Laboratory/medical personnela | |||
| Reference measurement procedure | Manufacturer’s measurement procedure | Any method with verified metrological traceability | |||
| Sample type/number | Capillary whole blood/100 | Capillary whole blood/100 | |||
| Glucose concentrations | Number of samples | Glucose concentrations (mg/dl) | Number of samples | Glucose concentrations (mg/dl) | |
| 5% | <50 | 5% | ≤50 | ||
| 15% | 50-80 | 15% | >50-80 | ||
| 20% | 80-120 | 20% | >80-120 | ||
| 30% | 120-200 | 30% | >120-200 | ||
| 15% | 201-300 | 15% | >200-300 | ||
| 10% | 301-400 | 10% | >300-400 | ||
| 5% | >400 | 5% | >400 | ||
| • Only unaltered samples between 50 and 400 mg/dl | • Only unaltered samples between >80 and 300 mg/dl | ||||
| • At least 8 unaltered samples between >50 and 80 mg/dl | |||||
| • At least 5 unaltered samples between >300 and 400 mg/dl | |||||
a
Not clearly defined but indicated (“trained operators” in ISO 15197:2013).