Chapter 7 Hgm-112 Performance Characteristics - Omron HGM-112 Instruction Manual

Chapter 7 HGM-112 Performance Characteristics

Traceability:
The test result of HGM-112 blood glucose meter is plasma calibrated by
chemistry analyzer, and the analyzer was calibrated with a NIST traceable
glucose standard solution.
Measurement range:
HGM-112 meter display results between 20 ~ 600 mg/dL.
Accuracy:
The accuracy of the HGM-112 meter was assessed by comparing blood
glucose results obtained by patients with those obtained using clinical
analyzer. The following results were obtained by (200) test numbers.
Slope
y-intercept mg/dL
Correlation factor (R2)
Test number (n)
Test range mg/dL
Number and % of results within reference (for values were
Within ± 5 mg/dL
14/34 (41.2%)
Number and % of results within reference (for values were
Within ± 5 %
76/166 (45.8%) 121/166 (72.9%) 153/166 (92.2%) 162/166 (97.6%)
Within ± 10 mg/dL
33/34 (97.1%)
Within ± 10 %
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112
0.9713
-0.3191 mg/dL
0.9795
200
27-527 mg/dL
Within ± 15 mg/dL
34/34 (100%)
Within ± 15 %
75 mg/dL)
75 mg/dL)
Within ± 20 %
19