Abbott Afinion HbA1c Mode D'emploi page 13

Table 1: Method comparison. Afinion HbA1c vs. a laboratory HPLC met-
hod. Weighted Deming regression slope and intercept for 120 fingerstick
samples (3 sites, 3 lots).
slope
Intercept (% HbA1c)
Table 2: Method comparison. Afinion HbA1c vs. a laboratory HPLC
method. Weighted Deming regression slope and intercept for 120 venous
whole blood samples (3 sites, 3 lots).
slope
Intercept (% HbA1c)
Precision
Within device (total) precision of Afinion HbA1c used with the Alere
Afinion AS100 Analyzer was determined according to CLSI Protocol EP5-
A2. Afinion HbA1c Control C I, Control C II, and four EDTA whole blood
samples were analysed for 10 days, 2 runs per day and 4 replicates per run.
3 lots of Afinion HbA1c Test were used. Precision data are summarised in
Table 3 (% HbA1c) and Table 4 (HbA1c, mmol/mol).
Table 3: Within device (total) precision. N (Number of replicates per
lot)=80. CV=Coefficient of Variation.
Sample
Low
Threshold
Medium
High
Control C I
Control C II
Estimate
1.00
0.00
Estimate
0.99
0.05
Lot 1
% CV
HbA1c (%)
5.2 1.1
6.5 1.2
8.4 1.1
11.8 1.0
6.3 1.0
8.3 0.9
95 % lower
bound
0.97
-0.21
95 % lower
bound
0.96
-0.16
Lot 2
CV
% HbA1c
(%)
5.1 1.1
6.4 1.1
8.4 1.1
11.8 0.9
6.1 1.0
8.5 0.8
95 % upper
bound
1.03
0.20
95 % upper
bound
1.02
0.27
Lot 3
CV
% HbA1c
(%)
5.0 1.3
6.4 0.9
8.4 1.0
11.8 1.2
6.2 0.9
8.4 0.8
EN
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