Table 3.
Relative Bias and Limits of Agreement according to Bland and Altmana
BG system | Reference method | Average relative bias (%) | Test strip lot | Relative bias (%) | Lower limit of agreement (%) | Upper limit of agreement (%) |
---|---|---|---|---|---|---|
Accu-Chek Aviva (system A) | HK | -0.4 | A1 | -0.7 | -11.8 | 10.5 |
A2 | 1.1 | -8.3 | 10.5 | |||
A3 | -1.0 | -10.5 | 8.5 | |||
A4 | -0.9 | -10.0 | 8.3 | |||
FreeStyle Lite (system B) | GOx | -4.0 | B1 | -0.8 | -7.6 | 5.9 |
B2 | -6.0 | -22.0 | 10.1 | |||
B3 | -1.4 | -11.8 | 9.0 | |||
B4 | -7.7 | -20.2 | 4.8 | |||
GlucoCheck XL (system C) | GOx | 2.8 | C1 | 4.6 | -13.3 | 22.4 |
C2 | 2.7 | -16.9 | 22.4 | |||
C3 | 2.3 | -20.8 | 25.4 | |||
C4 | 1.5 | -17.7 | 20.6 | |||
Pura/mylife Pura (system D) | HK | -9.0 | D1 | -6.7 | -19.5 | 6.1 |
D2 | -17.3 | -33.9 | -0.7 | |||
D3 | -4.3 | -16.4 | 7.8 | |||
D4 | -7.6 | -19.2 | 4.0 | |||
OneTouch Verio Pro (system E) | GOx | 8.8 | E1 | 8.5 | -4.2 | 21.2 |
E2 | 9.5 | -4.0 | 22.9 | |||
E3 | 8.7 | -3.0 | 20.4 | |||
E4 | 8.5 | -5.0 | 22.0 |
Reference methods (GOx or HK) as mentioned in the manufacturer's labeling. For the calculation of the relative bias of each test strip lot, data of 200 blood samples (BG concentrations <50 to >400 mg/dl) were included. The average relative bias of a BG system is the mean value of the four corresponding test strip lots' relative biases.