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Document Name:
SARS-CoV-2 Ag Test Strip Product Insert
Document Number:
S-COM-DOUT-00112
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-00001
Result interpretation:
The results will be displayed on the Instrument screen -
examples of result screen display:
NOTE: A negative result, from patients with symptoms onset beyond twelve days, should be treated as
presumptive and confirmation with a molecular assay, if necessary, for patient management, may be
performed
Invalid test results
If an issue occurs, a message will be displayed on the
Instrument touch-screen. Alert messages include
useful information and are highlighted by an orange
banner. Error messages also include a
symbol. All
messages will contain a description of the Instrument
status or error and an instruction. Error messages
contain an identifying code that may be used for
further troubleshooting purposes. Refer to the
LumiraDx Platform User Manual if an error message is
displayed on the LumiraDx Instrument touch-screen
and contact LumiraDx Customer Services on
telephone number 1-888-586-4721.
Example of an error screen:
If the On Board Control
(OBC) fails, an error message will be shown and no
test result will be returned. Follow the on screen
instructions to dispose of the Test Strip and start a
new test. If the problem persists, contact Customer
Services.
Fig 1: Negative result for
SARS-CoV-2 Ag
Fig 2: Positive result for
SARS-CoV-2 Ag
Summary of Contents for SARS-CoV-2
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