2014-09-30
Page 25 of 34
R-Biopharm AG
Choosing quality control (QC) materials
The authorized manufacturers of the RIDA
®
CUBE SCAN 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 RIDA
®
CUBE SCAN 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 sample” sections (starting on p. 22) 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 R-Biopharm supplier for assistance before proceeding on testing any
new samples.