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.
Number and % of results within reference (for values were
＜
75 mg/dL)
Number and % of results within reference (for values were
≧
75 mg/dL)
76/166 (45.8%) 121/166 (72.9%) 153/166 (92.2%) 162/166 (97.6%)
Slope
y-intercept mg/dL
Correlation factor (R2)
Test number (n)
Test range mg/dL
-0.3191 mg/dL
0.9713
200
27-527 mg/dL
0.9795
19
Within ± 5 % Within ± 10 % Within ± 15 % Within ± 20 %
14/34 (41.2%) 33/34 (97.1%)
34/34 (100%)
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
BLOOD GLUCOSE MONITORING SYSTEM-HGM-112
