LumiraDx SARS-CoV-2, Manual

Page: 27 / 118

3 of 5
Document Name: SARS-CoV-2 Antigen (Ag) Quality Controls Pack Insert
Document Number: S-COM-DOUT-00132 Revision: 2
This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for
the most recent version unless formally issued and stamped by QA. Created with S-QMS-TEM-00002
1. Draw up the Quality Control solution into the Transfer pipette .
2. Apply the Quality Control solution to the already inserted SARS-CoV-2 Ag Test Strip.
Hold the pipette over the Sample Application Area of the Test Strip and dispense the Quality
Control solution. The LumiraDx Instrument will indicate sample is detected with an audible
alert (if the Instrument sounds are enabled). The screen of the LumiraDx Instrument will
request the user to close the door. Dispose of pipette.
3. Do not open the door while the test is in progress . The touch-screen will indicate test
progress.
4. The Result will appear on the touch-screen within 12 minutes of applying the Quality Control
solution and starting the test. The results will be displayed as a PASS or FAIL QC result for
SARS-CoV-2 Ag on the instrument screen.
5. NOTE: If you need to repeat a test, use a new Test Strip.
Expected results : The Instrument displays the result as Pass or Fail. The result is automatically saved
in the memory of the Instrument. The system is working properly and all handling has been done
correctly when the test results obtained are displayed as PASS.
Symbols glossary:
Symbol Meaning
Temperature limitation
Manufacturer
For In Vitro Diagnostic Use Only
Catalogue Number
Lot Number
Use-by Date – indicates the date after which the unopened IVD/Quality
Control Material cannot be used
Indicates a control material that is intended to verify the performance
characteristics of the LumiraDx Instrument. An indication of the level of
control is shown in the box, e.g.1 or 2