CELL-DYN
®
3200 System Operator’s Manual
4-13
9140181H—October 2001
Section 4 Performance Characteristics and Specifications
For MCV and MPV, three bead sizes were analyzed and the method of least-
squares regression (not forcing the intercept through zero) was used for analysis of
the data. It should be noted that the reference diameters of the latex particles were
calculated by the manufacturer using electronic impedance volume analysis. The
optical analysis on the CELL-DYN 3200 is sensitive to the refractive index of the
latex particles and although the relationship is linear, a regression through zero is
not possible.
Correlation
The CELL-DYN 3200 system can be calibrated to agree with reference values
within the allowable calibration ranges. Both modes of operation, Open and Closed
(CS and SL) may be calibrated. Thus, it is possible to compensate for differences
between modes due to differing aspiration pathways or operational sequences.
When each mode is properly calibrated according to the directions given in this
manual, bias between the modes is clinically insignificant.
Accuracy specifications are determined by correlation to reference values obtained
from comparison analyzers or analysis by reference methodology. Samples that are
used for correlation studies should not display any suspect parameter flags.
Table 4.11 and Table 4.12 demonstrate the accuracy of the hemogram parameters
and WBC Differential parameters respectively.
Hemogram Parameters
All parameters were correlated against the CELL-DYN 3700, except for MCV,
MPV, RDW, and RETIC % which were correlated against the CELL-DYN 4000.
Table 4.11 Accuracy of Hemogram Parameters
Parameter Correlation Coefficient
WBC (WOC) >
0.99
WBC (NOC) >
0.99
RBC >
0.98
HGB >
0.98
MCV >
0.98
RDW >
0.91
PLT >
0.98
MPV >
0.72
RETIC % >
0.90
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