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Monitoiminen valvontasarja

Turvallinen AQ UG

Bi-functional blood glucose and uric acid monitoring system; Automatic strips ejection; ISO15197 2013 approved; Smart code for uric acid test

Yleiskatsaus

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).

määrittely
Test Function Verensokeri Uric Acid
Testausmenetelmä FAD-GDH Oxidized Ferrocene Derivative
Näytetyyppi 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)
Testiaika 5s 25s
Muisti 500 asettaa 100 asettaa
Strip validity 24 kuukautta 17 kuukautta
◆ Blood glucose user performance evaluation:
Results for glucose concentrations<100 mg/dL (<5.55mmol/l)
Sisällä ± 5mg / dL
(within ± 0.28mmol/l)
Sisällä ± 10mg / dL
(within ± 0.56mmol/l)
Sisällä ± 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)
± 5%: n sisällä
± 10%: n sisällä
± 15%: n sisällä
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)
± 5%: n sisällä
57.6% (49 / 85)
± 10%: n sisällä
94.1% (80 / 85)
± 15%: n sisällä
100% (85 / 85)