COULTER HmX Hematology Analyzer, Reference Manual

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PN 4237523A 4-14
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER WITH AUTOLOADER
Accuracy of CBC Parameters - HmX Hematology Analyzer with Autoloader
Evaluation of the CBC parameter accuracy was by subtraction of 69 paired test results given
by the HmX Hematology Analyzer with Autoloader Primary Aspiration Mode and the HmX
Hematology Analyzer with Autoloader Secondary Aspiration Mode.
Evaluation of the Five-Part Differential Accuracy was by subtraction of 38 paired test results
given by the HmX Hematology Analyzer with Autoloader Primary Aspiration Mode and the
HmX Hematology Analyzer with Autoloader Secondary Aspiration Mode. See Table 4.21.
Table 4.20 Imprecision Analysis (Diff Parameters) by Paired Sample - HmX Hematology Analyzer with
Autoloader
Cell Type Mean Difference% SD of Difference
Lymphocyte -0.91 6.36
Monocyte 0.43 3.41
Neutrophil 0.09 1.18
Eosinophil -0.05 0.29
Basophil 0.45 2.27
Table 4.21 Accuracy Analysis by Compared Specimens - HmX Hematology Analyzer with Autoloader
Parameter Units
Clinical Range
Mean Diff. SD Low High
WBC
x 10
9
cells/L
1.10 55.20 -0.07 0.12
RBC
x 10
12
cells/L
2.31 6.59 -0.04 0.04
Hgb g/dL 8.00 17.50 -0.12 0.08
MCV fL 69.60 125.60 -0.07 1.07
RDW % 11.04 26.50 -0.04 0.28
Plt
x 10
9
cells/L
10.0 715.0 -10.86 11.57
MPV fL 5.60 10.8 -0.03 0.30
Lymphocyte % 11.5 67.1 0.61 4.85
Monocyte % 1.50 26.20 -0.35 3.00
Neutrophil % 31.40 74.40 -0.48 4.07
Eosinophil % 0.00 9.00 0.08 0.36
Basophil % 0.00 1.7 0.15 0.64