COULTER HmX Hematology Analyzer, Reference Manual

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PN 4237523A 4-9
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER
4
clinical sensitivity. For CBC parameters, a Model S-PLUS IV analyzer provided reference data.
The performance of this instrument had been independently validated against the following
methods:
The results of replicate precision testing (n = 31) for each parameter measured by the test
instrument are given in Table 4.8.
Table 4.9 lists the results of Pair Difference analysis for 194 paired clinical blood specimens.
WBC:
Model ZBI™/CHANNELYZER
®
analyzer. Certified volumetric glassware
RBC: Model ZBI/CHANNELYZER analyzer. Certified volumetric glassware
Plt: Model ZBI/CHANNELYZER analyzer. Certified volumetric glassware
Hgb: NCCLS method H15-A
MCV: NCCLS packed cell volume method H7-A. For WBC differential parameters, the
reference values were provided by the method described in NCCLS publication
H20 (using an 800 cell count).
Table 4.8 Imprecision Analysis by Replication WHOLE BLOOD - HmX Hematology Analyzer
Parameter Units Mean SD CV%
WBC
x 10
9
cells/L
5.15 0.10 1.94
RBC
x 10
12
cells/L
4.55 0.06 1.32
Hgb g/dL 13.07 0.12 0.92
MCV fL 86.1 1.1 1.28
RDW % 12.56 0.21 1.67
Plt
x 10
9
cells/L
206.7 8.78 4.25
MPV fL 9.69 0.15 1.55
Table 4.9 Imprecision Analysis by Paired Sample - HmX Hematology Analyzer
Parameter Units
Clinical Range
Mean Diff. SD Low High
WBC
x 10
9
cells/L
0.4 46.8 -0.01 0.20
RBC
x 10
12
cells/L
2.06 5.92 0.00 0.04
Hgb g/dL 7.2 17.7 0.01 0.13
Hct % 22.1 53.1 0.10 0.68
MCV fL 67.8 123.9 0.15 1.26
MCH pg 21.8 41.6 0.35 0.37
MCHC g/dL 30.7 36.6 -0.04 0.67
RDW % 11.0 26.4 0.00 0.28
Plt
x 10
9
cells/L
1.0 710.0 0.51 11.85
MPV fL 8.6 15.0 0.01 0.93