HemoCue WBC, Operating Manual

Page: 41 / 68

41
Validation Studies
Results of the validation studies, based on the intended
use of the system, are shown in Figure 1, 2, 3 and 4. Sin-
gle replicate on the HemoCue WBC system and the mean
of duplicate on the comparative method are presented in
the plots. Validation studies are performed according to
the CLSI Document EP9-A2.
Figure 1
Point-of-Care
Figure 2
Clinical Laboratory
H
em
o
C
u
e W
B
C
, x
10
9
/L
Sysmex XS-1000i, x10
9
/L
Coefficients:
b
0
= – 0.045
b
1
= 1.006
r 2 = 0.991
N = 280
------- X = Y
H
em
o
C
u
e W
B
C
, x
10
9
/L
Sysmex XS-1000i, x10
9
/L
------- X = Y
Coefficients
b
0
= – 0.263
b
1
= 1.042
r
2
= 0.995
N = 116