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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

Oversikt

      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).

Spesifikasjon
Testfunksjon Blodsukker Urinsyre
Testmetode FAD-GDH Oxidized Ferrocene Derivative
Prøvenype Peripheral capillary whole blood/venous whole blood Peripheral capillary whole  blood/venous whole blood
Blodprøve
0.6 ul 3 ul
Testområde 20-600 mg / dL
 (1.1-33.3mmol/L)
3.0-20.0 mg / dL
(181-1188 µmol/L)
Testtid 5s 25s
Minne 500 setter 100 setter
Strip validity 24 måneder 12 måneder
◆ Blood glucose user performance evaluation:
Results for glucose concentrations<100 mg/dL (<5.55mmol/l)
Innen ± 5 mg / dL
(within ± 0.28mmol/l)
Innen ± 10 mg / dL
(within ± 0.56mmol/l)
Innen ± 15 mg / 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)
Innen ± 5%
Innen ± 10%
Innen ± 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)
Innen ± 5%
57.6%(49/85)
Innen ± 10%
94.1%(80/85)
Innen ± 15%
100%(85/85)





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