Diatron Abacus 5 - Performance Characteristics; Precision; Accuracy; Linearity

151
22.7 Performance Characteristics
22.7.1 Precision
Device repeatability and reproducibility are defined as a standard deviation (SD) or as a coefficient of variation
(CV), whichever is greater. Specifications are provided for primary and derived parameters only.
Parameter
Repeatability
Reproducibility/Precision
Units
SD
CV%
SD
CV%
WBC
< 0.18
< 2.7 %
< 0.20
< 3.4%
10
3
/µl
NEU%
< 3.50
< 3.50
%
LYM%
< 3.10
< 3.10
%
MON%
< 2.00
< 2.00
%
EOS%
< 2.00
< 2.00
%
BAS%
< 0.50
< 0.50
%
RBC
< 0.11
< 1.7 %
< 0.13
< 2.0%
10
6
/µl
HGB
< 0.20
< 2.0 %
< 0.22
< 2.4%
g/dl
MCV
< 1.0
< 1.7 %
< 1.20
< 2.0%
fL
RDWcv
< 0.4
< 2.5%
< 0.45
< 3.0%
%
PLT
< 23
< 6.0 %
< 27
< 7.0%
10
3
/µl
MPV
< 0.45
< 8.7 %
< 0.50
< 10.0%
fL
Table 26. Precision Performance
22.7.2 Accuracy
Device accuracy is defined as a maximum predicted difference (bias) between this analyzer and an alternate
method. The difference must be less than the absolute or percent difference criteria in the table below over an
expected range. Specifications are provided for primary and derived parameters only.
Parameter
Criteria
Range
Units
Absolute
Percent
Low
High
WBC
0.30
6.00%
0.00
100.00
10
3
/µl
NEU%
3.00
10.00%
0.00
100.00
%
LYM%
3.00
10.00%
0.00
100.00
%
MON%
3.00
10.00%
0.00
40.00
%
EOS%
1.50
10.00%
0.00
30.00
%
BAS%
0.50
40.00%
0.00
5.00
%
RBC
0.15
6.00%
0.00
8.00
10
6
/µl
HGB
0.30
6.00%
1.00
25.00
g/dl
MCV
1.00
6.00%
50.00
120.00
fL
RDWcv
0.50
6.00%
8.00
20.00
%
PLT
15.00
8.00%
0.00
1000.00
10
3
/µl
MPV
0.80
10.00%
5.00
20.00
fL
Table 27. Accuracy Performance
22.7.3 Linearity
Linearity is defined for the primary measured parameters.
Parameter
Coefficient of
Determination
(R
2
)
Nonlinearity
Absolute
Error
Nonlinearity
Relative
Error
Linearity
Range
Low
Linearity
Range
High
Units
WBC
> 0.95
< 0.80
< 3.0 %
0.2
100.0
10
3
/µl
RBC
> 0.95
< 0.20
< 3.0 %
0.36
7.19
10
6
/µl
HGB
> 0.95
< 0.27
< 3.0 %
1.1
22.2
g/dl
PLT
> 0.95
< 35
< 3.0 %
15
1000
10
3
/µl
Table 28. Linearity Performance