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Chapter 8 HEA-230 Performance Characteristics
The test result of Premium glucose monitoring system is plasma
calibrated by chemistry analyzer, and the analyzer was calibrated with a
NIST traceable glucose standard solution.
Measurement range:
The HEA-230 display results between 20 and 600 mg/dL (1.1 ~ 33.3
mmol/L).
Accuracy:
The accuracy of the HEA-230 was assessed by comparing blood
glucose results obtained by patients with those obtained using clinical
analyzer. The following results were obtained 120 subjectsat at 2 clinical
centers.
Slope 1.0384
y-intercept 1.6664 mg/dL (0.0925 mmol/L)
Correlation factor (n) 0.9827
Patient number (n) 240
Test range 40~443 mg/dL (2.2~24.6 mmol/L)
Number and % of results within reference (for values were
＜
75 mg/
dL(4.2 mmol/L))
Within ± 5 mg/dL
(0.3mmol/L)
Within ± 10 mg/dL
(0.6mmol/L)
Within ± 15 mg/dL
(0.8mmol/L)
26/40 (65 %) 34/40 (85 %) 39/40 (97.5 %)
Number and % of results within reference (for values were
≧
75 mg/
dL(4.2 mmol/L))
Within ± 5 % Within ± 10 % Within ± 15 % Within ± 20 %
67/200 (33.5 %) 135/200 (67.5 %) 178/200 (89 %) 197/200 (98.5 %)
Precision:
This study shows the variability from strip to strip in blood tests. The
results are shown in the folling table.
Within Run Precision
Samples Mean glucose concentration measured CV
Sample 1 57.1 mg/dL(3.2mmol/L)
SD=4.4 mg/dL (0.2
mmol/L)
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