Abbott Afinion HbA1c Mode D'emploi page 14

Table 4: 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
Performance testing with the AFINION
The performance of Afinion HbA1c used with the Afinion 2 Analyzer has
been demonstrated to be equivalent to the performance obtained with the
Alere Afinion AS100 Analyzer.
EN
14 Afinion HbA1c
Lot 1
HbA1c
CV
(mmol/
(%)
mol)
33 2.0
47 1.7
69 1.5
106 1.2
46 1.4
68 1.4
Lot 2
HbA1c
CV
(mmol/
(%)
mol)
32 1.6
46 1.6
68 1.6
106 1.1
43 1.5
69 1.0
2 Analyzer
™
Lot 3
HbA1c
CV
(mmol/
(%)
mol)
32 1.9
46 1.4
68 1.2
105 1.4
44 1.5
68 1.0