BIOFIRE 423744 COVID-19 Test v1.1 User Guide
- June 6, 2024
- BioFire
Table of Contents
BioFire®COVID-19 Test v1.1 Quick Guide
For use with FilmArray®2.0 and FilmArray® Torch Systems
UPPER RESPIRATORY
DO NOT DISCARD: Important product-specific information For in vitro diagnostic
use under Emergency Use Authorization (EUA) only
Package Contents
NOTE: Use clean gloves and other Personal Protective Equipment (PPE) when performing this procedure.
Step 1: Prepare Pouch
a. Insert pouch into Pouch Loading Station.
b. Place Sample Injection Vial into the red well.
c. Place Hydration Injection Vial into the blue well.
Step 2: Hydrate Pouch
a. Unscrew Hydration Injection Vial from cover.
b. Remove Hydration Injection Vial, leaving blue plastic cover in Pouch
Loading Station.
c. Insert Hydration Injection Vial into pouch hydration port.
d. Push down to puncture seal and wait as Hydration Solution is drawn into the
pouch.
NOTE: Verify the pouch has been hydrated.
Step 3: Prepare Upper Respiratory Sample Mix
a. Use the transfer pipette to draw the specimen to the 3rd line.
Add specimen to Sample Injection Vial.
b. Hold Sample Buffer Tube tip facing up and firmly pinch at the textured
plastic tab on side of the tube until seal snaps.
NOTE: Do not touch tube tip.
c. Dispense Sample Buffer into Sample Injection Vial using a slow, forceful
squeeze followed by a second squeeze.
NOTE: Avoid generating excessive foam.
d. Tightly close the lid on the Sample Injection Vial, invert it 3 times, and
return it to the red-well of the Pouch Loading Station.
WARNING: Sample Buffer is harmful if swallowed and can cause serious eye damage and/or skin irritation.
Step 4: Load Upper Respiratory Sample Mix
a. Unscrew Sample Injection Vial from red plastic cover.
b. Wait for 5 seconds, then lift Sample Injection Vial, leaving red plastic
cover in Pouch Loading Station.
NOTE: Waiting 5 seconds decreases the contamination risk.
c. Insert Sample Injection Vial into pouch sample port.
d. Push down to puncture seal and wait as Sample Mix is drawn into the pouch.
NOTE: Verify the sample has been loaded.
Step 5: Run Pouch
a. Discard the Sample Injection Vial and the Hydration Injection Vial in a
biohazard sharps container.
b. Follow instructions on the computer for starting a test.
Step 6: Review Results
Run Summary – Displays information about the sample and a summary of the
Internal Controls and test results.
1. Internal Controls:
• If ‘Passed’, results are valid.
• If ‘Failed’ or ‘Invalid’, RETEST SAMPLE and refer to Instructions for Use.
2. Result Summary – Displays overall SARS-CoV-2 test result on the first
line, followed by each individual assay result.
• If the overall ‘SARS-CoV-2’ test result is ‘Detected’ or ‘Not Detected’,
report the results.
• If ‘Invalid’, RETEST SAMPLE and refer to Instructions for Use.
3. Run Details – Displays information about the pouch, protocol, run status,
operator, pouch serial number, instrument, and pouch lot number.
Run Status:
• If ‘Completed’, the run is complete.
• If ‘Incomplete’, ‘Aborted’, or any other error message, RETEST SAMPLE and
refer to Instructions for Use.
NOTE: Refer to Instructions for Use for reporting information.
If repeated error messages are obtained, contact BioFire Defense Technical
Support.
Conditions of Authorization
The BioFire COVID-19 Test has not been FDA cleared or approved but has been
authorized for emergency use by FDA under a EUA for use by authorized
laboratories.
The BioFire COVID-19 Test has been authorized only for the detection of
nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of the BioFire COVID-19 Test is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for the detection
and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food,
Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is
terminated or authorization is revoked sooner.
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