21/65
Table 1 Difference distribution for glucose concentration < 100 mg/dL (5.55
mmol/L)
Tested sites
Difference within
±5mg/dL
Difference within
±10mg/dL
Difference within
±15mg/dL
Fingertip
71.4% (35/49)
95.9% (47/49)
100% (49/49)
Table 2 Difference distribution for glucose concentration ≥ 100 mg/dL (5.55
mmol/L)
Tested sites
Difference within
±5mg/dL
Difference within
±10mg/dL
Difference within
±15mg/dL
Fingertip
55.0% (61/111)
88.3% (98/111)
97.3% (108/111)
Precision
In both intermediate precision and repeatability tests, the standard deviation (SD)
is within 5 mg/dL (0.28 mmol/L) for each glucose concentration < 100 mg/dL
(5.55 mmol/L) and the coefficient of variation (CV) is less than 5% for each
glucose
concentration ≥ 100 mg/dL (5.55 mmol/L).
(2)
HCT:
Accuracy:
≦
±
5% ; Precision: SD
≦
3
(3)
HB:
Accuracy:
≦
1.7 g/dL ; Precision: SD
≦
3 g/dL
In our system, the HB is calculated by HCT. Our device is not directly got the
value of HB. All the hemoglobin (HB) detect tested data are calculated from
hematocrit (HCT) detect tested results (Hb = HCT x 0.34). Based on this, the Hb
detect linearity performance results are the same as HCT detect linearity
performance results. However, normal accuracy requirement on market (without
any formal regulatory requirements) is ±1.5%.
