COULTER HmX Hematology Analyzer, Справочное руководство

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PN 4237523A 4-6
SPECIFICATIONS/CHARACTERISTICS
CBC AND DIFFERENTIAL PERFORMANCE SPECIFICATIONS
Mode-to-Mode Matching
Minor differences between the Primary (cap-pierce or autoloader) and Secondary (manual)
modes are due to differences in the flow characteristics of the aspiration pathways.
Additionally, flow characteristics vary between samples. Verification of the minor
mode-to-mode differences seen on the HmX Hematology Analyzer and HmX Hematology
Analyzer with Autoloader requires elimination of effects of carryover and within-mode
precision in testing. For these reasons, the specification is based on the average values for 10
normal bloods measured in triplicate (three consecutive measurements). When verification is
performed according to this protocol, differences between the averages of the two modes do
not exceed the following limits in Table 4.5:
Data collected using "blind paired" samples has demonstrated that variability observed in the
paired samples between Primary and Secondary modes is similar to the variability observed
within a mode.
Background Counts
Background count for the WBC differential is
≤
100 total counts collected from all regions of
the scatterplot. For CBC parameters background count, see Table 4.6.
Table 4.4 Linearity Limits
Parameter Linearity Range Limits: The greater of:
WBC x 10
3
cells/µL
0 to 99.9 ±0.2 or 3.0%
RBC x 10
6
cells/µL
0 to 7.00 ±0.05 or 2.0%
Hgb g/dL 0 to 25.0 ±0.2 or 2.0%
MCV fL 50.0 to 150.0 ±2.0 or 2.0%
Plt x 10
3
cells/µL
0 to 999 ±10.0 or 7.0%
MPV fL 5.0 to 20.0 ±5.0%
Table 4.5 Mode-to-Mode Matching
Parameter Limits: The greater of:
WBC x 10
3
cells/µL
±0.4 or 5.0%
RBC x 10
6
cells/µL
±0.2 or 2.0%
Hgb g/dL ±0.3 or 2.0%
Plt x 10
3
cells/µL
±20.0 or 7.0%
Table 4.6 Background Counts for CBC Analysis
Parameter Counts
WBC x 10
3
cells/µL
≤
0.4
RBC x 10
6
cells/µL
≤
0.0
Hgb g/dL
≤
0.1
Plt x 10
3
cells/µL
≤
3.0