Table 1.
Meters | Mean difference* (mmol/L) | SD (mmol/L) | 95% Limits of agreement ± 2 SD | Mean bias (%)† | Mean total analytical error %bias +1.96*CV (%) | Coefficient of variation between meters (%) | |
---|---|---|---|---|---|---|---|
ACA |
0.361 |
0.55 |
−0.749 |
1.470 |
8.99 |
14.87 |
−0.220 |
OPT20s |
0.572 |
0.66 |
−0.747 |
1.890 |
13.08 |
26.21 |
2.597 |
ACP |
0.385 |
0.57 |
−0.758 |
1.528 |
9.04 |
15.65 |
−0.299 |
OPT5s |
0.725 |
0.62 |
−0.523 |
1.972 |
15.76 |
32.14 |
−0.796 |
FSL |
0.232 |
0.69 |
−1.157 |
1.622 |
6.37 |
17.07 |
1.416 |
STAT | 0.256 | 0.54 | −0.817 | 1.329 | 6.10 | 12.29 | −0.623 |
ADA stipulates the most stringent goals, aiming for an analytical error <5% or total error (user plus analytical) <10%. All meters were calibrated to provide plasma glucose results, except one that reported capillary whole blood glucose, and adjusted plasma values were calculated as whole blood glucose = plasma glucose × [1 − (0.0024 × HCT)] for the Accu-Chek Advantage-II meter (13).
ACA, Accu-Chek Advantage-II (Roche Diagnostics, Mannheim, Germany) strips Lot No.450808; OPT20s, OptiumXceed 20 s strips Lot No. 54277 (Abbott Diabetes Care, Alameda, CA); ACP, Accu-Chek Performa (Roche Diagnostics) strips Lot No. 320151; OPT5s, OptiumXceed 5 s strips Lot No. 99884–5 (Abbott Diabetes Care); FSL, FreeStyle Lite (Abbott Diabetes Care) strips Lot No. 0820633; STAT, Stat-Strip (Nova Biomedical, Waltham, MA) strips Lot No. 0308273249.
*Mean difference = (mean of the meters − plasma glucose).
†[(meter − plasma glucose/plasma glucose)] × 100.