LumiraDx SARS-CoV-2, Manual

Page: 5 / 118

5 of 21
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
When indicated by the touchscreen, open the foil pouch just before use and insert the LumiraDx Test
Strip into the LumiraDx Instrument. The Instrument will indicate when it is ready for the sample to be
applied.
The LumiraDx SARS-CoV-2 Ag Test results should be evaluated by a Healthcare Professional in the
context of all available clinical and laboratory data.
Instructions for sample collection:
When collecting any type of sample, follow universal collection precautions and guidelines according to
your organization. For specimen collection of nasal swabs, follow the Centers for Disease Control and
Prevention (CDC) Swab Collection Guidelines and swab manufacturers’ recommendations. Users
should be trained in appropriate specimen collection and handling procedures.
The steps that follow apply to a nasal swab. For information on recommended swabs to use with the
LumiraDx SARS-CoV-2 Ag Test, please refer to the Limitations section of this Product Insert.