Siemens ADVIA 2120, Руководство оператора, Страница: 348 / 477

Regulatory Information 9-7
Product
Number Symbol Contents Amount
(mL)
- T03-3685-01 Hematology
Calibrator 6.1 mL
ADVIA 120 OPTIpoint
Product
Number Contents Amount (mL)
04408568 T03-3682-54 OPTIpoint 4 x 6.0 mL
- T03-3682-01 OPTIpoint 6.0 mL
NOTE:
Control products for the CSF Method and the Reticulocyte method are
described in those sections.
Calibrator and Control Value Assignment Methods
All assigned target values for ADVIA SETpoint Hematology Calibrator and
ADVIA TESTpoint Hematology Controls are traceable to NIST, ICSH, or
NCCLS recommended procedures or approved reference procedures and
materials.
The reference Red Blood Cell (RBC) and White Blood Cell (WBC) counts are
performed using the recommended method with a single-channel aperture
impedance counter. Macro-dilutions of 1:500 for WBC and 1:50,000 for RBC are
made using Class A glassware. The reference Platelet Count (Plt) is performed
using a hemocytometer and phase-contrast microscopy. The macro-dilution for
Plt is 1:125 using 1% ammonium oxalate as the diluent. The reference
hemoglobin method is performed using the NCCLS H-15A approved standard
method with ICSH traceable certified hemoglobin standards. The reference
microhematocrit is performed using NCCLS H-7A approved standard method
with tripotassium EDTA as the anticoagulant.
The System Specific Target Values (SSV) are assigned for ADVIA 120
SETpoint Hematology Calibrator and ADVIA 120 TESTpoint Hematology
Control products by assaying each lot on an ADVIA 2120/2120i Hematology
System that was calibrated using fresh, normal, whole-blood samples that were
assigned RBC, WBC, Plt, Hct, and Hgb values using the methods described
above.