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Safe AQ UG
Bi-functional blood glucose and uric acid monitoring system; Automatic strips ejection; ISO15197 2013 approved; Smart code for uric acid test
Overview
The Safe AQ UG Blood Glucose and Uric Acid Monitoring System is designed for the quantitative measurement of glucose and uric acid in fresh capillary whole blood samples and in venous whole blood samples. The Safe AQ UG Blood Glucose and Uric Acid Monitoring System is for use outside the body only (in vitro diagnostic use) for self-testing and professional use as an aid in the management of diabetes and hyperuricemia (HUA).
Specification
| Test Function | Blood Glucose | Uric Acid |
|---|---|---|
| Test method | FAD-GDH | Oxidized Ferrocene Derivative |
| Sample type | Peripheral capillary whole blood/venous whole blood | Peripheral capillary whole blood/venous whole blood |
| Blood sample | 0.6µl | 3µl |
| Test range | 20-600mg/dL (1.1-33.3mmol/L) | 3.0-20.0mg/dL （181-1188 µmol/L） |
| Test time | 5s | 25s |
| Memory | 500 sets | 100 sets |
| Strip validity | 24 months | 12 months |
◆ Blood glucose user performance evaluation:
| Results for glucose concentrations<100 mg/dL (<5.55mmol/l) | ||
|---|---|---|
| Within ± 5mg/dL (within ± 0.28mmol/l) | Within ± 10mg/dL (within ± 0.56mmol/l) | Within ± 15mg/dL (within ± 0.83mmol/l) |
| 50%(14/28) | 85.71% (24/28) | 100% (28/28) |
| Results for glucose concentrations ≥ 100 mg/dL (≥5.55mmol/l) | ||
| Within ± 5% | Within ± 10% | Within ± 15% |
| 55.56%(40/72) | 90.28%（65/72) | 97.22%(70/72) |
◆ Uric acid user performance evaluation:
| Results for uric acid concentrations < 297μmol/L (5.0 mg/ dL) | ||
|---|---|---|
| Within ± 14.9μmol/L (Within ± 0.3 mg/ dL) | Within ± 29.7μmol/L (Within ± 0.5 mg/ dL) | Within ± 59.4μmol/L (Within ± 1.0 mg/ dL) |
| 40.0%(6/15) | 60.0% (9/15) | 100% (15/15) |
| Results for uric acid concentrations≥ 297μmol/L (5.0 mg/ dL) | ||
| Within ± 5% 57.6%(49/85) | Within ± 10% 94.1%（80/85) | Within ± 15% 100%(85/85) |
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