LumiraDx SARS-CoV-2, Руководство пользователя

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Remove seal Soak Swab Squeeze Swab Attach Dropper Lid
Remove the seal from the top of the
Extraction Vial containing the
Extraction Buffer .
Place and soak the Patient Swab in the
Extraction Buffer for 10 seconds then stir well by
rotating the swab against the side of the vial 5
times.
Remove the Patient Swab while
squeezing the E xtraction Vial to
remove the liquid from the swab.
Discard the swab in biohazard waste.
Firmly attach the Dropper Lid to the top of the Extraction Vial.
The extracted sample must be used (see Step 5 and 6 below) within 5h of
preparation when stored at room temperature.
Running the Test
4. Select the appropriate sample type and
confirm the test type.
5. Gently invert the
Extraction Vial five times
just before applying the
sample to the Test Strip .
6. Apply
one whole drop
of
the sample onto the Test
Strip Sample Application
Area when prompted by the
Instrument .
7. Close the door when
prompted to continue the
test.
8. Results are displayed within 12 minutes of applying the
sample. The left-hand image here shows a positive result for
SARS-CoV-2 Ag and the right-hand image shows a negative
result for SARS-CoV-2 Ag. Tap Finish to complete testing or tap
Comment to leave a comment or to reject the Test, then follow
prompts to return to the Home Screen . All test results must be
read using the Lumiradx Instrument.
1. Select Patient Test from the Instrument Home
Screen and enter patient details using the
Keyboard or Barcode Scanner.
See section 10 of the
Platform User Manual
for
instructions on using the Barcode Scanner.
2. Remove the Test Strip from its
pouch and hold by gripping only the
blue portion. Do not bend the Test
Strip or touch any part other than the
blue portion.
3. When prompted, open the Instrument door and gently insert the Test Strip as far as it will go. The thick
black alignment rib on the Test Strip should be on the left and line up with the black line on the Instrument.
Do not apply the sample until prompted.
Install the Lot Calibration file if using a new
Test Strip Lot
for the first time. See section 2.8 of the
Platform
User Manual.