LumiraDx SARS-CoV-2, Manual

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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
5)
Performing a Test (refer to the Quick Reference Instructions to make sure that your Instrument
has been prepared before starting this step).
If using a frozen sample, the sample must be at room
temperature before testing.
1. Gently invert
the Extraction Vial five times (5x) just before applying the sample to the Test Strip.
2. Apply the extracted sample from the Extraction Vial onto the Sample Application Area of the
inserted Test Strip. To do this gently press the sides of the extraction vial until one whole drop is
visible and allow it to touch the Sample Application Area of the Test Strip. The sample will then be
drawn by capillary action into the Test Strip. When the sample is detected the Instrument will sound
(if sounds are enabled) and a confirmation message will be displayed. The touchscreen of the
LumiraDx Instrument will request the user to
immediately close the door (Note: you have 10
seconds only to close the door).
3. Do not add more than one drop of sample . Do not open the door while the test is in progress.
The touchscreen will indicate test progress.
4. The result will appear on the Instrument touchscreen within 12 minutes of applying the sample and
starting the test. The results will be displayed as a positive or negative result SARS-CoV-2-Ag
on the Instrument screen. (see Fig 1 and Fig 2).
5.
Dispose of the swab, Extraction Vial and Test Strip in the appropriate biohazard waste.
6.
Disinfect the Instrument between each patient test using either the LumiraDx approved wipes such
as TECcare CONTROL wipes, or Virkon or Clorox wipes. Use the wipe until the surface of the
Instrument is visibly wet. Allow the surface to remain wet for
5 minutes and let air dry.
7.
If you need to retest , you will use a new Test Strip. Use the same extraction vial and repeat the
test. The extracted sample must be used within 5 hours of preparation when stored at room
temperature. Extracted nasal specimens may be frozen at -80°C and used up to 5 days after
freezing.
Gently invert the Extraction Vial five times just before applying
the sample to the Test Strip.