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QBC STAR™ System User's Manual
In a separate precision study, intra- and inter-run precision were assessed using a dual level QBC Control (#424304). The
controls were assayed on multiple days at three sites using QBC STAR tubes and the QBC STAR system. The results of this
study are presented in the table below.
Parameter
Site
BD
HCT (%)
POL #1
POL #2
BD
HGB (g/dL)
POL #1
POL #2
BD
PLT (x 10
9
/L)
POL #1
POL #2
BD
WBC (x
POL #1
10
/L)
9
POL #2
BD
GRAN (x
POL #1
10
/L)
9
POL #2
LYMPH/
BD
MONO
POL #1
(x 10
/L)
POL #2
9
*Variability between runs during the same days
** Variability between tubes on the same run during the same day (error)
Accuracy
The performance of the QBC STAR system is based on data from venous blood samples collected in VACUTAINER
lection tubes containing K
for comparing results from multiple methods. While skin puncture samples provide clinically relevant results, they are subject
to more variation due to the nature of the sampling technique.
Two QBC STAR tubes were prepared on each of approximately 323 blood samples and analyzed on both the QBC STAR system
and either the Coulter
STKS or Sysmex K1000 analyzers*. The correlation coeffi cients for the WBC, Gran, L/M, Hct, and Hgb,
®
and PLT parameters were 0.95 or greater. Complete statistical results are presented below.
5–2
Control Precision
Control Level 1
Intra-Day*
Mean
%CV
df
Value
30.46
0.28
10
30.93
1.37
10
30.71
0.73
9
10.07
0.00
10
10.16
1.49
10
10.22
0.82
9
443.33
0.00
10
382.78
4.06
10
459.37
0.00
9
9.18
0.00
10
9.74
0.00
10
9.32
4.33
9
4.80
0.00
10
5.27
0.00
10
5.06
2.89
9
4.38
1.49
10
4.48
0.00
10
4.26
5.35
9
EDTA anticoagulant. Venous blood samples provide a more stable test system than capillary blood
3
Intra-Run**
Intra-Day*
Mean
%CV
df
%CV
Value
1.58
20
34.87
0.00
1.66
20
35.27
1.22
1.12
19
34.65
0.00
1.52
20
11.65
0.00
1.48
20
11.69
1.06
1.00
19
11.66
0.14
10.64
20
194.55
6.50
4.02
20
163.48
2.08
11.08
19
204.18
0.00
5.83
20
21.31
0.00
7.22
20
21.67
1.03
5.17
19
19.88
5.61
8.96
20
5.51
4.82
8.79
20
6.23
2.92
6.70
19
5.37
0.00
5.62
20
15.81
0.00
6.52
20
15.44
1.75
6.56
19
14.52
7.63
df = degrees of freedom
0.00 denotes a negative variance estimate
Control Level 2
Intra-Run**
df
%CV
df
10
0.95
20
10
2.26
20
9
1.25
19
10
0.99
20
10
2.34
20
9
1.18
19
10
18.86
20
10
3.31
20
9
12.84
19
10
7.45
20
10
5.40
20
9
9.57
19
10
5.25
20
10
8.31
20
9
8.68
19
10
8.96
20
10
7.59
20
9
12.61
19
brand col-
®
L–000867(A)
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