Accuracy, Brand collection tubes containing k – Drucker Diagnostics QBC STAR Dry Hematology Analyzer User Manual
Page 42
QBC Star System Operator’s Manual
6000-300-000 5–2
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.
Control Precision
Accuracy
the performance of the QBC Star system is based on data from venous blood samples collected in VaCUtaINEr
®
brand collection tubes containing K
2
EDta anticoagulant. Venous blood samples provide a more stable test system than
capillary blood 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 coefficients for the WBC, Gran, L/M,
Hct, and Hgb, and Plt parameters were 0.95 or greater. Complete statistical results are presented on following page.
Control Level 1
Control Level 2
Intra-Day*
Intra-Run**
Intra-Day*
Intra-Run**
Parameter
Site
Mean
Value
%CV
df
%CV
df
Mean
Value
%CV
df
%CV
df
HCt (%)
BD
POL
#1
POL
#2
30.46
30.93
30.71
0.28
1.37
0.73
10
10
9
1.58
1.66
1.12
20
20
19
34.87
35.27
34.65
0.00
1.22
0.00
10
10
9
0.95
2.26
1.25
20
20
19
HGB (g/dL)
BD
POL
#1
POL
#2
10.07
10.16
10.22
0.00
1.49
0.82
10
10
9
1.52
1.48
1.00
20
20
19
11.65
11.69
11.66
0.00
1.06
0.14
10
10
9
0.99
2.34
1.18
20
20
19
PLt (x 10
9
/L)
BD
POL
#1
POL
#2
443.33
382.78
459.37
0.00
4.06
0.00
10
10
9
10.64
4.02
11.08
20
20
19
194.55
163.48
204.18
6.50
2.08
0.00
10
10
9
18.86
3.31
12.84
20
20
19
WBC (x 10
9
/L)
BD
POL
#1
POL
#2
9.18
9.74
9.32
0.00
0.00
4.33
10
10
9
5.83
7.22
5.17
20
20
19
21.31
21.67
19.88
0.00
1.03
5.61
10
10
9
7.45
5.40
9.57
20
20
19
GraN (x
10
9
/L)
BD
POL
#1
POL
#2
4.80
5.27
5.06
0.00
0.00
2.89
10
10
9
8.96
8.79
6.70
20
20
19
5.51
6.23
5.37
4.82
2.92
0.00
10
10
9
5.25
8.31
8.68
20
20
19
LYMPH/
MONO
(x 10
9
/L)
BD
POL
#1
POL
#2
4.38
4.48
4.26
1.49
0.00
5.35
10
10
9
5.62
6.52
6.56
20
20
19
15.81
15.44
14.52
0.00
1.75
7.63
10
10
9
8.96
7.59
12.61
20
20
19
*Variability between runs during the same days
** Variability between tubes on the same run during the same day (error)
df = degrees of freedom
0.00 denotes a negative variance estimate
6000-300-000 5-2