BioFire COVID-19 Test v1.0 User Guide

BioFire COVID-19 Test v1.0 User Guide

DO NOT DISCARD: Important product-specific information

For in vitro diagnostic use under an Emergency Use Authorization (EUA) only

Intended Use

The BioFire® COVID-19 Test v1.0 is a nested multiplexed real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in non- pooled, upper respiratory swab specimens (nasopharyngeal, oropharyngeal, mid- turbinate nasal, or anterior nasal swabs) in transport media from individuals suspected of COVID-19 by their healthcare provider. Please see www.fda.gov /medical-devices/emergency-situations-medical-devices/emergency-use- authorizations#covid19ivd for the BioFire
COVID-19 Test v1.0 Instructions for Use.

Storage Instructions

Store at 15 – 30ºC. Refer to the BioFire COVID-19 Test v1.0 Instructions for Use before opening and preparing pouch for use.

Procedure / Interpretation / Limitations

 Users should refer to the BioFire COVID-19 Test v1.0 Instructions for Use available on the BioFire Defense Website: www.biofiredefense.com/covid- 19test

Questions / Support

If you have questions or need additional support, please contact BioFire Defense Technical Support at [email protected].

Package Contents

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 red well.
c. Place Hydration Injection Vial into 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 Sample Mix

a. Use the transfer pipette to draw specimen in transport media to the 3rd line. Add specimen to Sample Injection Vial.
b. Hold Sample Buffer Tube tip facing up and firmly pinch at textured plastic tab on side of 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 and invert it 3 times, return it to the red well of Pouch Loading Station.
WARNING: Sample Buffer is harmful if swallowed and can cause serious eye damage and/or skin irritation.

Step 4: Load 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 five 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 computer for starting a test.

Step 6: Review Results

1. Run Summary – Displays information about the sample and a summary of the Internal Controls and test results.

2. Internal Controls:
   

   • If ‘Passed’, results are valid.

   • If ‘Failed’ or ‘Invalid’, RETEST SAMPLE and refer to Instructions for Use.
     Test Interpretation:
     

   • If ‘Detected’, or ‘Not Detected’, report the results. (Figure 1)

   • If ‘Equivocal’, RETEST SAMPLE and refer to Instructions for Use. (Figure 2)

3. Result Summary – Displays test interpretation (Top Line) with detailed assay results.

4. Run Details – Displays information about the pouch, protocol, run status, operator, serial number, instrument, and lot number.
   Run Status:
   

   • If ‘Completed’, run is complete.
   • If ‘Incomplete’, ‘Aborted’, or any other error message, RETEST SAMPLE and refer to Instructions for Use.

NOTE: Refer to BioFire COVID-19 Test v1.0 Instructions for Use for reporting information. If repeated error messages are obtained, contact BioFire Defense Technical Support.

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