Siemens ADVIA 2120, Operator'S Manual, Page: 373 / 477

9-32 Regulatory Information
PLT 0.1%
Performance Characteristics: Analytical Range
The analytical range for the ADVIA 2120/2120i Hematology System was
established by making serial dilutions of samples specially prepared to have high
analyte values. Multiple assays of the specially prepared pools were performed
on the system.
Parameter Range Evaluated Maximum Observed
Deviation
WBC (10³/µL) 0.02 to 21.83
20.48 to 409.55
0.46 x 10³/µL
4.1%
RBC (10
6
/µL) 0.0 to 2.65
2.65 to 6.76
0.03 x
10
6
/µL
1.1%
HGB (g/dL) 0.0 to 8.6
8.6 to 22.5
0.2 g/dL
2.5%
PLT (10³/µL) 5 to 208
205 to 3983
10 x 10³/µL
4.9%