COULTER HmX Hematology Analyzer, Reference Manual

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PN 4237523A 4-10
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER
Imprecision Analysis by Paired Sample of the Differential Parameters
Table 4.10 shows imprecision by pair analysis using normal blood for 194 paired
observations.
Table 4.11 shows precision by replication 31 times with a single specimen.
The reference range (normal values) for 160 subjects is given in Table 4.12.
Accuracy of CBC Parameters
Evaluation of accuracy by subtraction of paired test results given for COULTER HmX
Hematology Analyzer and for COULTER S-PLUS IV analyzer for 194 specimens is given in
Table 4.13
The magnitude of the mean differences expresses accuracy. The dispersion of differences (SD)
expresses the inclusive errors of imprecision and bias.
Table 4.10 Imprecision Analysis (Diff Parameters) by Paired Sample - HmX Hematology Analyzer
Cell Type Mean Difference SD of Difference
Lymphocyte 0.08 0.84
Monocyte 0.07 1.23
Neutrophil -0.01 1.26
Eosinophil -0.01 0.66
Basophil 0.01 0.53
Table 4.11 Imprecision Analysis (Diff Parameters) by Replication - HmX Hematology Analyzer
Cell Type Mean Percentage Standard Deviation
Lymphocyte 38.30 1.29
Monocyte 14.38 0.86
Neutrophil 43.22 0.55
Eosinophil 3.65 0.28
Basophil 0.34 0.15
Table 4.12 Reference Range (Diff Parameters) for 160 Subjects - HmX Hematology Analyzer
Cell Type Lower % Higher % Lower Absolute # Higher Absolute #
Lymphocyte 20.50 45.50 1.30 2.90
Monocyte 5.50 11.70 0.31 0.83
Neutrophil 43.00 65.00 2.20 4.80
Eosinophil 0.90 2.90 0.05 0.22
Basophil 0.25 1.00 0.02 0.06