Beckman Coulter COULTER LH 750 System, Справочник

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PN 4277248DD
4-2
SPECIFICATIONS/CHARACTERISTICS
PERFORMANCE SPECIFICATIONS--LH 700 Series
Accuracy
Accuracy Qualification
Accuracy is tested on a minimum of 150 non-flagged, morphological normal samples for CBC
and Diff, and 50 non-flagged samples for Retics analyzed between 10 minutes and 8 hours
post venipuncture.. Distributional abnormal samples should be included. NCCLS H20-A
42
criteria should be used in the sample selection and manual differential examination.
Accuracy, CBC
For the CBC parameters, the LH 700 Series can be adjusted within the resolution of the
readout to agree with a predetermined reference value at any point in the operating range.
Accuracy was tested against a predicate hematology analyzer. Table 4.2 lists the specifications
for the mean difference and mean percent difference.
Table 4.1 Within-Run Precision
Parameter @ Approximate Level Limit
WBC
9 to 11 x 10
3
cells/µL
≤
1.7% CV
RBC
4.5 to 5.5 x 10
6
cells/µL
≤
0.8% CV
Hgb 14 to 16 g/dL
≤
0.8% CV
MCV 80 to 90 fL
≤
0.8% CV
RDW 12 to 14%
≤
2.2% CV
Plt
280 to 320 x 10
3
cells/µL
≤
3.3% CV
Plt
90 to 110 x 10
3
cells/µL
≤
6.6% CV
Plt
10.0 to 15.0 x 10
3
cells/µL
≤
14.0% CV
MPV 8 to 10 fL
≤
2.2% CV
NE% 50 to 60% 2SD
≤
3.0
LY% 25 to 35% 2SD
≤
3.0
MO% 5 to 10% 2SD
≤
2.0
EO% 2 to 5% 2SD
≤
1.0
BA% 0.5 to 1.5% 2SD
≤
1.0
RET% 0.00 to 0.49% 1SD
≤
0.23 or 16.5% CV
RET% 0.50 to 1.49% 1SD
≤
0.23 or 14.5% CV
RET% 1.50 to 4.00% 1SD
≤
0.68 or 11.0% CV
RET% 4.01 to 15.00% 1SD
≤
0.68 or 5.5% CV
Table 4.2 Accuracy, CBC
Parameter Mean Difference Mean Percent Difference
WBC 0.00 to 100.0 ±0.2 ±3.5%
100.1 to 400.0 N/A ±9.0%
RBC ±0.05 ±2.0%