Method Data Summary
CBC Method Data
The sample stability, expected ranges, and performance characteristics for the CBC method are listed in the following Table.
Sample Stability
Room Temp
WBC (10³/µL)
36 h
6
RBC (10
/µL)
48 h
HGB (g/dL)
72 h
MCV (fL)
8 h
CH (pg)
36 h
CHCM (g/dL)
8 h
RDW (%)
72 h
HDW (g/dL)
72 h
PLT (10³/µL)
48 h
MPV (fL)
8 h
Hct (%)
MCH (pg)
n/a
MCHC (g/dL)
not available or not applicable for this parameter
x= Technicon H•3 RTC System y= ADVIA 120 Hematology System
Regulatory information
Expected
Refrigerated
Values
Mean
56 h
3.8 to 8.6
5.91
72 h
4.1 to 6.0
4.82
72 h
10 to 16
13.3
24 h
76 to 100
81.0
53 h
24 to 35
26.5
24 h
29 to 34
30.6
72 h
12 to 15
12.3
72 h
1.9 to 3.0
2.56
48 h
140 to 360
256
8 h
7 to 9
8.1
33 to 57
n/a
24 to 31
n/a
28 to 34
Imprecision
Correlation Data
SD
CV%
y=
0.16
2.7
1.06x - 0.74
0.05
1.0
0.98x + 0.11
0.11
0.8
1.01x - 0.2
0.3
0.4
0.90x + 9.6
0.05
0.2
1.00x + 1.2
0.14
0.5
1.17x - 6.5
0.07
0.6
0.86x + 1.3
0.02
0.8
0.98x + 0.06
6.9
2.7
1.08x - 2.0
0.11
1.4
0.76x + 0.9
n/a
n/a
n/a
n/a
Observed
r
Sy.x
Carryover
0.997
1.42
0.4%
0.02 to 21.83
20.48 to 409.55
0.997
0.07
0.2 %
2.65 to 6.76
0.997
0.2
0.2 %
0.994
1.1
0.990
0.6
0.974
0.5
0.980
0.6
0.959
0.13
0.991
27
0.1 %
205 to 3983
0.925
0.4
n/a
n/a
n/a
n/a
n/a
Analytical Range
Range
Deviation
0.46 x 10³/µL
4.1 %
6
0.0 to 2.65
0.03 x 10
/µL
1.1 %
0.0 to 8.6
0.2 g/dL
8.6 to 22.5
2.5 %
5 to 208
10 x 10³/µL
4.9 %
9-63