COULTER HmX Hematology Analyzer, Reference Manual

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PN 4237523A 4-13
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER WITH AUTOLOADER
4
4.6 PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER
WITH AUTOLOADER
Precision of the CBC Parameters
The results of replicate precision testing (n=31) for each parameter measured by the test
instrument are given in Table 4.18.
The results of Pair Difference analysis for 69 paired clinical blood specimens are given in
Table 4.19. Evaluation of the Pair Difference analysis of the CBC parameter was by
subtraction of 69 paired test results given by the HmX Hematology Analyzer with Autoloader
Primary Aspiration Mode.
Precision of the Differential Parameters - HmX Hematology Analyzer with Autoloader
Evaluation of the Pair Difference Analysis for the five-part differential was by subtraction of
38 paired test results given by the HmX Hematology Analyzer with Autoloader Primary
Aspiration Mode. See Table 4.20.
Table 4.18 Imprecision Analysis by Replication: WHOLE BLOOD - HmX Hematology Analyzer with
Autoloader
Parameter Units Mean SD CV%
WBC
x 10
9
cells/L
10.44 0.11 1.05
RBC
x 10
12
cells/L
4.98 0.025 0.5
Hgb g/dL 14.39 0.04 0.28
MCV fL 85.90 0.65 0.76
RDW % 12.34 0.15 0.12
Plt
10
9
cells/L
321.60 11.86 3.69
MPV fL 9.15 0.13 1.42
Table 4.19 Imprecision Analysis by Paired Sample - HmX Hematology Analyzer with Autoloader
Parameter Units
Clinical Range
Mean Diff. SD Low High
WBC
x 10
9
cells/L
1.10 55.20 0.00 0.13
RBC
x 10
12
cells/L
2.31 6.59 0.00 0.03
Hgb g/dL 8.00 17.50 -0.00 0.05
MCV fL 69.60 125.60 0.01 0.82
RDW % 11.04 26.50 -0.06 0.32
Plt
x 10
9
cells/L
10.0 715.0 -0.80 10.72
MPV fL 5.60 10.8 0.02 0.24