18
Chapter 8 HEA-232 Performance
Characteristics
Traceability:
The HEA-232 test result were calibrated to YSI readings. The
YSI analyzer was calibrated using a standard solution(180mg/
dL(10mmol/L) which can be traced to NIST SRM #917A.
Accuracy:
The results from the HEA-232 were compared with those from
YSI glucose analyzer. The study showed the HEA-232 results
were consistent with the YSI readings. The following results were
obtained from 115 subjects at 2 clinic centers.
Slope 1
1.0722
y-intercept
-6.2869mg/dL (-0.4mmol/L)
Correlation factor (R
2
)
0.9733
Patient number (n)
230
Test range
22~537mg/dL (1.2~29.8mmol/L)
Number and % of results within reference (for values were
＜
75 mg/dL)
Within ± 5 mg/dL
(0.3mmol/L)
Within ± 10 mg/dL
(0.6mmol/L)
Within ± 15 mg/dL
(0.8mmol/L)
10/32 (31.3 %)
26/32 (81.3 %)
32/32 (100 %)
Number and % of results within reference (for values were
≧
75 mg/dL)
Within ± 5 %
Within ± 10 %
Within ± 15 %
Within ± 20 %
104/198 (52.5 %) 149/198 (75.3 %) 177/198 (89.4 %) 194/198 (98.0 %)
When sample concentration < 75mg/dL(4.2mmol/L): 100% data fall within
± 15mg/dL(0.8mmol/L) with reference.
When sample concentration
≧
75mg/dL(4.2mmol/L): 98% data fall within ±
20% to reference.
Precision:
This study shows a variability from strip to strip in sample tests. The results
are shown in the following table.
Within Run Precision
Samples
Mean glucose concentration
measured CV
Sample 1
32.9 mg/dL (1.8mmol/L)
SD=1.8 mg/dL(0.1mmol/L)
OMRON blood glucose monitoring system HEA-232.indd 18
2012/6/13 下午 06:44:28
