COULTER HmX Hematology Analyzer, Справочное руководство

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PN 4237523A 4-11
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER
4
Accuracy of Differential Parameters
The HmX Hematology Analyzer was evaluated in a typical clinical laboratory environment
using both normal subjects and hospitalized subjects. The reference method with which the
HmX Hematology Analyzer was compared is described in NCCLS publication H20.
Because of the unsuitability of regression analysis, accuracy is expressed as the mean
difference between reference method (H20) values and the HmX Hematology Analyzer values
for 203 normal subjects. The scatter of the data conformed to the limits of a binomial
distribution envelope. Table 4.14 gives the mean difference percent.
Clinical Sensitivity
The ability of the HmX Hematology Analyzer to "flag" abnormal specimens was compared to
the performance of the NCCLS publication H20 (using an 800 cell count) method using the
reference limits listed in Table 4.15. Except for nucleated red cells, absolute count values
were used.
Table 4.13 Accuracy Analysis by Compared Specimens - HmX Hematology Analyzer
Parameter Units
Clinical Range
Mean Diff. SD Low High
WBC
x 10
9
cells/L
0.50 45.80 0.22 0.39
RBC
x 10
12
cells/L
1.98 5.88 0.06 0.07
Hgb g/dL 7.30 17.80 0.02 0.24
Hct % 21.00 51.30 0.60 0.82
MCV fL 68.80 120.30 0.26 1.32
MCH pg 22.50 42.10 0.35 0.68
MCHC g/dL 30.40 36.20 -0.49 0.93
RDW % 11.40 26.00 -0.59 0.30
Plt
x 10
9
cells/L
7.10 628.00 2.24 15.20
MPV fL 5.30 14.90 -0.27 0.27
Table 4.14 Accuracy Analysis (Diff Parameters) by Compared Specimens - HmX Hematology Analyzer
Cell Type Mean Difference %
Lymphocyte -1.19
Monocyte -0.51
Neutrophil -0.23
Eosinophil 0.47
Basophil -0.18