Arkray Assure 530001, Справочное руководство

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SECTION
C
21
Obtained by Healthcare Professionals Obtained by Lay Users
Slope 1.017 1.022
Y-intercept -7.39 mg/dL -8.31 mg/dL
Correlation
coefficient(r)
0.992 0.992
Number of samples 122 118
Range tested 40-577 mg/dL 58-577 mg/dL
Precision
Studies were performed in a laboratory using the Assure Prism multi
Blood
Glucose Monitoring System
.
Within Run Precision
Blood avg.* 41.4 mg/dL SD = 1.8 mg/dL
Blood avg.* 79.6 mg/dL SD = 2.8 mg/dL
Blood avg.* 129.8 mg/dL CV = 2.6%
Blood avg.* 201.9 mg/dL CV = 3.1%
Blood avg.* 349.6 mg/dL CV = 2.7%
Total Precision
Control avg.* 36.2 mg/dL SD = 1.3 mg/dL
Control avg.* 117.0 mg/dL CV = 2.3%
Control avg.* 321.8 mg/dL CV = 2.4%
* This study shows that there could be variation of up to 3.5%.
ACCURACY AND PRECISION STUDIES
Performance Characteristics
The performance of the Assure® Prism multi Blood Glucose Monitoring System has been
evaluated in laboratory and clinical tests.
ACCURACY: The Assure Prism multi Blood Glucose Monitoring System is calibrated to yield
results equivalent to plasma glucose concentrations. The accuracy of the Assure Prism multi
Blood Glucose Monitoring System was tested by comparing blood glucose results obtained by
patients with those obtained using a YSI Model 2300 Glucose Analyzer, a lab instrument.
The results below were obtained by diabetic patients at clinic centers.
Accuracy
Results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
11/11 (100%) 11/11 (100%) 11/11 (100%)
Results for glucose concentration ≥ 75 mg/dL
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
47/111 (42%) 89/111 (80%) 109/111 (98%) 111/111 (100%)