Beckman Coulter COULTER LH 750 System, Справочник

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PN 4277248DD
4-5
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE CHARACTERISTICS
4
replaced by pluses (
+++++
). The reportable range identifies the values where the instrument
is accurate, and reflects the range studied in accuracy testing. See Table 4.6.
Mode-to-Mode Comparison
Automatic (closed vial) and Manual (open vial) mode-to-mode differences of the means of 10
hematologically "normal" blood specimens, measured in triplicate, or 50 samples from
accuracy testing should be less than or equal to the following:
WBC ± 0.4 x 10
3
cells/µL or 5%, whichever is greater
RBC ± 0.2 x 10
6
cells/µL or 2%, whichever is greater
Hgb ± 0.3 g/dL or 2%, whichever is greater
Plt ± 20 x 10
3
cells/µL or 7%, whichever is greater
In addition, 95% of the individual differences should be within the stated limits.
*National Committee for Clinical Laboratory Standards is now the Clinical and Laboratory
Standards Institute (CLSI).
4.3 PERFORMANCE CHARACTERISTICS
The information in this section describes typical performance for an instrument that has been
properly maintained as indicated in the COULTER LH 700 Series documentation, using the
recommended reagents.
Table 4.6 Operating and Reportable Ranges
Parameter Operating Range Reportable Range
WBC
0.00 to 900.00 x 10
3
cells/µL 0.00 to 400.00 x 10
3
cells/µL
RBC
0.00 to 20.00 x 10
6
cells/µL 0.00 to 8.00 x 10
6
cells/µL
Hgb 0.0 to 99.9 g/dL 0.0 to 25.0 g/dL
Hct 0.0 to 99.9% N/A
MCV 0.0 to 300.00 fL 0.0 to 150.0 fL
MCH 0.0 to 99.9 pg N/A
MCHC 0.0 to 99.9 g/dL N/A
RDW 0.0 to 99.9% N/A
Plt
0.00 to 5000 x 10
3
cells/µL 0.00 to 3000 x 10
3
cells/µL
Pct 0.0 to 9.999% N/A
MPV 0.0 to 99.9 fL N/A
PDW 0.0 to 99.9% N/A
NE%, LY%, MO%, EO%, BA% 0 to 100% 0 to 100%
NE#, LY#, MO#, EO#, BA#
0.00 to 900.00 x 10
3
cells/µL 0.00 to 400.00 x 10
3
cells/µL
RET% 0.00 to 100% 0.00 to 30.0%
RET#
0.00 to 999.9 x 10
6
cells/µL 0.0000 to 0.7500 x 10
6
cells/µL
NRBC% 0.0 or 2.0 to 600 % 0.0 or 2.0 to 600 %