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CHAPTER 05. Quality Control
Control Test
It is important to perform control tests with more than one level of control to
assure your system is working properly and your testing technique is good.
When to use the control
· Using the analyzer for the rst time.
· To check the test device when you open a new device packaging.
· If you drop the analyzer.
· Whenever your result does not agree with the way you feel.
· If you repeat a test, and the result is still lower or higher than expected.
· When you want to check the performance of the analyzer and test device.
Before using the control
· Check the expiration date. Do not use after expiration or discard date (date
opened plus three months), whichever comes rst.
How to Run the Quality Control
1. To run the quality control according to the specic test type. Refer to the assay-
specific package insert for preparing the test with QC control that is proper
for the each type of the test device. Enter operator ID and CS Info before the
staring.
Note
The operator ID and CS Info can be entered into the analyzer with
touch panel or USB keyboard. And they can be entered with SDB
barcode reader as well which is purchased separately.
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