Siemens ADVIA 2120, Руководство оператора, Страница: 356 / 477

Regulatory Information 9-15
System Method Information: Storage and Stability
Reagent and calibrator storage and expiration dates are printed on the product
label. When stored unopened these products are stable through the last day of the
month stated in the expiration date, unless stated otherwise.
System Method Information: Sample Handling
Whole blood specimens whose parameter values exceed the analytical range may
be diluted with autologous plasma or isotonic saline and reassayed unless stated
otherwise in the method-specific information.
System Method Information: Materials Required but not
Provided
This topic lists the additional materials, other than the reagents, that are required
to perform the methods.
System Method Information: Procedure
For general operating instructions, refer to the Daily Routine.
System Method Information: Quality Control
This section specifies recommended quality control material and quality control
frequency for the individual method. In general, Siemens recommends that
ADVIA 2120/2120i Hematology Systems be monitored using the ADVIA
TESTpoint Hematology Controls (Low, Normal, and High) and ADVIA
TESTpoint Reticulocyte Control (Low and High). Please refer to page 5 for
product descriptions.
Control materials should be assayed at the beginning of each shift or at some
other interval chosen by the laboratory, after a reagent lot number change, and
after replacement of any part or component of the analytical module that may
affect analytical performance.
The laboratory must evaluate all control results before reporting patient results. If
control results fail to meet the laboratory’s established criteria for acceptability,
all patient test results obtained in the unacceptable test run must be evaluated to
determine if patient test results were adversely affected. The laboratory should
take and document appropriate corrective actions, which may include
recalibration and reassaying of patient samples, before reporting patient results.
System Method Information: Gain Adjustment
The gain adjustment procedure is used to adjust the amplification of signals in a
channel to properly position the cell signatures within a cytogram.
Materials Required for Adjusting Gains
•
Whole Blood
•
ADVIA 120 OPTIPOINT