HemoCue WBC Manuel D'utilisation page 40

Specific Performance Characteristics
Linearity
The method used in the HemoCue WBC system has
accor ding to the CLSI Document EP6-A been dem-
onstrated to be linear between 0.3–30.0 x10
(300–30000/mm , 300–30000/µL), within 0.2 x10
3
difference in 0.3–3.5 x10 /L and within 6 % difference
9
in 3.6–30.0 x10 /L.
9
Within-run and Total Precision
Within-run and Total Precision was determined accor ding
to the CLSI Document EP5-A2. The results given below
come from four batches of HemoCue WBC Microcu-
vettes, and five HemoCue WBC Analyzers. Commercially
available controls at three different levels were used. The
WBC count was measured in duplicate twice a day, morn-
ing and afternoon, during 20 consecutive days.
Level N x10 /L Within-run
9
Precision
CV %
1 400 2.5 4.1
2 400 7.2 2.9
3 400 19.0 1.6
Additionally, a study has been performed to determine
the precision using fresh blood samples. The study was
performed on venous whole blood samples tested in
duplicate.
/L
9
/L
9
x10 9 /L
0.3–1.0 12
1.1–3.5 52
3.6–10.0 209
10.1–20.0 88
20.1–30.0 35
Total 396
Total
Precision
CV %
5.4
3.5
1.9
40
N CV %
duplicates
Sysmex XS-1000i HemoCue WBC
5.0 10.4
3.7
1.9 3.5
2.1 2.5
1.8 2.2
2.4 3.2
4.1