alphacheck CareSens Dual Bedienungsanleitung Seite 75

Performance Characteristics
The performance of alphacheck CareSens Dual Blood Glucose/
Blood β-Ketone Monitoring System has been evaluated in
laboratory and in clinical tests.
Glucose
Accuracy: The accuracy of the alphacheck CareSens Dual Blood
Glucose Monitoring System (Model: GM01HAC) was assessed by
comparing blood glucose results obtained by patients with those
obtained using a YSI Model 2300 Glucose Analyzer, a laboratory
instrument.
The following results were obtained by diabetic patients at clinic
centers.
Slope
Y-intercept
Correlation coefficient (r)
Number of tests
Range tested
System accuracy results for glucose concentration < 100 mg/dL
(5.55 mmol/L)
Within ±5 mg/dL Within ±10 mg/dL
(Within ±0.28 mmol/L) (Within ±0.56 mmol/L)
136/204 (66.7 %) 197/204 (96.6 %)
System accuracy results for glucose concentration ≥ 100 mg/dL
(5.55 mmol/L)
Within ±5 % Within ±10 %
264/396 (66.7 %) 379/396 (95.7 %)
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0.964
3.579 mg/dL (0.199 mmol/L)
0.997
600
46.2–526 mg/dL (2.6–29.2 mmol/L)
Within ±15 mg/dL
(Within ±0.83 mmol/L)
203/204 (99.5 %)
Within ±15 %
395/396 (99.7 %)
System accuracy results for glucose concentrations between
46.2 mg/dL (2.6 mmol/L) and 526 mg/dL (29.2 mmol/L)
Within ±15 mg/dL (Within ±0.83 mmol/L) and Within ±15 %
598/600 (99.7 %)
Precision: The precision studies were performed in a laboratory
using alphacheck CareSens Dual Blood Glucose Monitoring Systems.
Within Run Precision
Blood 45 mg/dL (2.5 mmol/L)
average
77 mg/dL (4.3 mmol⁄L)
124 mg/dL (6.9 mmol/L)
185 mg/dL (10.3 mmol/L) CV = 3.3 %
293 mg/dL (16.3 mmol/L) CV = 3.0 %
Between Run Precision
Control 42 mg/dL (2.3 mmol/L)
average
120 mg/dL (6.7 mmol/L)
311 mg/dL (17.3 mmol/L) CV = 3.1 %
This study shows that there could be variation of up to 4.2 %.
Packed Cell Volume (Hematocrit)
The hematocrit levels (15–65 %) were tested to evaluate the effect
of hematocrit level on measurement of glucose concentration.
Range mg/dL (mmol/L)
30–50 (1.7–2.8)
96–144 (5.3–8.0)
280–420 (15.5–23.3)
SD = 2.3 mg/dL (0.1 mmol/L)
SD = 3.0 mg/dL (0.2 mmol/L)
CV = 4.2 %
SD = 1.6 mg/dL (0.1 mmol/L)
CV = 4.1 %
Average of difference (Hct 15–65 %)
-3.3–1.7 mg/dL (-0.2–0.1 mmol/L)
-3.6–1.7 %
-8.9–6.2 %
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