Siemens ADVIA 2120, Руководство оператора, Страница: 380 / 477

Regulatory Information 9-39
•
After a reagent lot number change.
•
After replacement of any part or component of the analytical module that
may affect analytical performance.
NOTE:
Moving Average calculations are not available for CSF results.
Results
The system automatically performs all calculations necessary for obtaining
results for undiluted samples (samples prepared 1:1 with CSF reagent) and
displays them on the Run Screen.
ADVIA 2120/2120i results should be reviewed for conditions listed in the
Limitations of the Procedure. If a sample displays any of the listed conditions,
the results should be confirmed.
The results of samples that have been diluted with PBS or normal saline prior to
preparation with CSF reagent must be corrected for the dilution factor. If a
sample is diluted, the absolute counts should be multiplied by the dilution factor.
Enter the dilution factor in the Dil. field of the Order Entry tab when creating the
workorder. The results displayed in the Review \ Edit tab and printed on the final
patient report will be automatically corrected by the entered dilution factor. For
example, if a sample is diluted 1:5 (1 part sample and 4 parts normal saline or
PBS), the absolute counts will be multiplied by 5. The differential percentages
are not affected by dilution, and will not be multiplied by the dilution factor
when correcting on the Review \ Edit tab. Results on the Run Screen are not
corrected for the dilution factor.
The Laser Power Low (PL) system flag is enabled for CSF analysis.
High/Low flagging is provided for all CSF parameters through range definitions
set in the Data Manager.
Limitations of the Procedure
The limitations of the procedure are as listed:
1. CSF WBC percent differential results for samples with WBC counts less than
20 cells/µL should be confirmed using an alternate method.
2. The ADVIA 120 CSF Assay can accurately analyze samples with up to 1500
RBC/
μ
L. Samples that are suspected of containing greater than 1500
RBC/
μ
L may be diluted up to 1:10 with PBS.
3. The ADVIA 2120/2120i Hematology System provides no morphology
flagging to indicate the presence of abnormal cells in the CSF Assay. Only
High / Low flagging and the Laser Power Low system flag are enabled for
the CSF Assay.
4. Improper sample handling or failure to review CSF cytograms for possible
interferences/analysis artifacts may produce erroneous results. Examples of
improper sample handling include, but are not limited to:
♦
Inadequate mixing of CSF patient sample or prepared sample before