Abbott CELL-DYN 3200 - Linearity

4-12
CELL-DYN
®
3200 System Operator’s Manual
9140181H—October 2001
Performance Characteristics and Specifications
Performance Specifications
Section 4
Linearity
Linearity specifications are determined by analyzing dilutions of a linearity
material that contains no interfering substances and displays no suspect parameter
flags. Specifications are determined by taking multiple measurements on each
dilution to minimize the effect of imprecision. The stated limits are determined by
regression analysis. This analysis is performed with the line going through the
origin (0,0) except for the RETIC % parameter. Table 4.10 contains the linearity
specifications for the hemogram parameters.
Table 4.9 Precision of the WBC Differential Parameters (N=20)
Parameter Specimen Range % 95% Confidence Limit
Neutrophil % 46–75 ± 2.2
Lymphocyte % 20–45 ± 2.8
Monocyte % 3.5–11.5 ± 2.7
Eosinophil % 0.5–8.0 ± 1.0
Basophil % 0.5–2.0 ± 1.0
Table 4.10 Linearity Specifications
Parameter Linear Range
Absolute
Deviation
Relative
Deviation
WOC (WBC)
0.0–250 K/
µL
± 0.4 < 4.0%
NOC (WBC)
0.0–250 K/
µL
± 0.4 < 4.0%
RBC
0.00–8.00 M/
µL
± 0.1 < 2.5%
HGB 0.0–25.0 g/dL ± 0.3 <
2.0%
MCV 34.0–172 fL ± 2.0 <
2.0%
PLT
0.0–1750 K/
µL
± 10.0 < 7.0%
MPV 2.0–18.0 fL ± 1.0 <
9.0%
RETIC % 0.50–23.00% ± 1.1 <
7.0%