2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04
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Eurolyser Diagnostica GmbH
QUALITY CONTROL
A quality control program should be performed on a regular basis to verify the Eurolyser CUBE-S/CUBE
Instrument is working properly and providing reliable results. Data integrity can only be assured when
controls and GCLP practices are used routinely. The frequency of performing QC differs from laboratory
to laboratory; please comply with your national quality control regulations.
Choosing quality control (QC) materials
The authorized manufacturers of the CUBE-S/CUBE test cartridges also supply control materials. These
control kits contain control materials, which allow you to assess the measuring accuracy of the
Instrument.
Ensure the measuring methods are compatible with the Eurolyser CUBE-S/CUBE Instrument before
using QC kits from other suppliers.
The measuring methods are listed on the test cartridge’s package insert.
Handling the QC control materials
Please refer to the package insert provided with each control kit for detailed instructions on
storage and handling of control materials.
Follow the instructions in the “Analysing a patient sample” sections (starting on p. 24) on how to properly
perform a control test. The measured values must be within the range of target values specified on the
control vial label or in the control package insert. If the control results fall within the specified range, the
testing of patient samples may begin.
If one or more controls tested are outside the specified control range:
-
Verify that the control materials have been stored according to the directions and that the
expiration date has not passed
-
Verify that the handling and testing procedures were performed according to the directions on the
package insert
-
Repeat the control test, using a new control from the same lot
If one or more control results are still outside the specified range:
-
Perform a test using a control from a new lot.
If all instructions have been followed but control results are still not within range please
contact your local Eurolyser supplier for assistance before proceeding on testing any
patient samples.
