Beckman Coulter COULTER LH 750 System, Reference

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PN 4277248DD
4-4
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE SPECIFICATIONS--LH 700 Series
Background
Background counts for CBC parameters are performed during the Startup cycle. The
background limits are
Carryover
High-to-Low Carryover on the LH 700 Series should meet these limits:
Carryover is the discrete amount of analyte carried by the measuring system from one
specimen reaction into subsequent specimen reactions, thereby erroneously affecting the
apparent amounts in subsequent specimens" (NRSCL8-A 1998. Clinical Laboratory
Standards Institute). It is conventionally expressed as a percentage of the concentration of the
analyte in the first specimen which is carried into the subsequent specimen, as indicated by
the specified limits listed above.
Operating and Reportable Ranges
The operating ranges reflect the range of values over which the instrument displays, prints
and transmits results. Values that are between the linear range and the operating range, and
values outside the reportable range, are displayed, printed and transmitted with an over linear
range flag (+). Values that are above the operating range are inhibited, and the value is
Table 4.5 Linearity Limits
Parameter Linearity Range
Limits (mean difference or
%
difference, whichever is greater)
WBC x 10
3
cells/µL
0.00 to 100.0
100.1 to 400.0 ±0.2 or 3.0%
±9%
RBC x 10
6
cells/µL
0.00 to 8.00 ±0.05 or 2.0%
Hgb g/dL 0.0 to 25.0 ±0.2 or 3.0%
Plt x 10
3
cells/µL
0 to 3000 ±10 or 7.0%
WBC
≤
0
.
20
RBC
≤
0.01
Hgb
≤
0.20
Plt
≤
3.00
DIFF
≤
100 events
RETIC
≤
600 events
WBC
≤
2.0%
RBC
≤
1.0%
Hgb
≤
2.0%
Plt
≤
2.0%
DIFF
≤
200 events
RETIC
≤
600 events