FlimArray DFA2-ASY-0003 Global Fever Panel

Product Specifications

• Product Name: Global Fever Panel – RUO kit
• Model Number: DFA2-ASY-0003

COMPONENTS

For Research Use Only. Not For Diagnostic Use.

NOTE: Components from the Global Fever Panel – RUO kit should not be stored or used with any other kit.

To avoid contamination, always wear clean gloves and work behind a protective shield.

Prepare Pouch

Step 1:

• a. Insert pouch into Pouch Loading Station.
• b. Place Sample Injection Vial into red well.
• c. Place Hydration Injection Vial into blue well.

Hydrate Pouch

Step 2:

• a. Unscrew the Hydration Injection Vial from cover.
• b. Remove Hydration Injection Vial, leaving blue plastic cover in Pouch Loading Station.
• c. Insert Hydration Injection Vial into 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.

Prepare Sample Mix

Step 3:

NOTE: Gently invert sample container until thoroughly mixed.

• a. Use the Transfer Pipette to draw sample to the 2nd line. Add the sample to Sample Injection Vial.
  Add Sample Buffer (NOTE: There are 2 possible designs of the Sample Buffer Ampoule)
• b. Hold the Sample Buffer Ampoule with the tip facing up.
  NOTE: Do not touch the tip of the ampoule.
• c. Firmly pinch textured plastic tab on the side of the ampoule until the seal snaps or if there is no textured tab on the side, gently twist off the plastic tab on the tip.
• d. Dispense Sample Buffer into Sample Injection Vial using a slow, forceful squeeze, followed by a 2nd squeeze.
  NOTE: Avoid generating excessive foam.
• e. Tightly close lid and invert the Sample Injection Vial 3 times.
• f. Return Sample Injection Vial to red well of Pouch Loading Station.
  WARNING: Sample Buffer is harmful if swallowed and can cause serious eye damage and/or skin irritation.

Load Sample Mix

Step 4:

• a. Unscrew Sample Injection Vial from red plastic cover.
• b. Wait for 5 seconds, then remove 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 Sample Port.
• d. Push down to puncture seal, then wait as sample mix is drawn into the pouch.

Run Pouch

Step 5:

a. Follow the instructions on the computer for starting a test.

1. Run Summary – Displays information about the sample, and a summary of the controls, test results and recommended action.
   • Run Status:
     • If ‘Completed’, run is complete.
     • If ‘Incomplete’, ‘Aborted’, or any other error message, RETEST SAMPLE.
   • Internal Controls:
     • If ‘Pass’, results are valid.
     • If ‘Fail’ or ‘Invalid’, RETEST SAMPLE.
2. Results Summary – Displays the test results for each organism.
   1. ‘Detected’: Lists names of any detected organisms.
   2. ‘Not Detected’: Lists names of organisms that were not detected.
3. Pouch Summary – Displays information about the pouch, serial number, and lot number.
   NOTE: Refer to the FilmArray Global Fever Panel – RUO Instructions for Use for reporting information. If repeated error messages are obtained, contact BioFire Defense Technical Support.

BioFire Defense, LLC | 79 West 4500 South, Suite 14, Salt Lake City, Utah 84107 USA | 801-262-3592 | www.BioFireDefense.com

Frequently Asked Questions

• Q: Can components from the Global Fever Panel – RUO kit be stored or used with other kits?
  A: No, components from this kit should not be stored or used with any other kit to prevent contamination.

Documents / Resources

FlimArray DFA2-ASY-0003 Global Fever Panel [pdf] User Guide DFA2-ASY-0003 Global Fever Panel, DFA2-ASY-0003, Global Fever Panel, Fever Panel, Panel

References

• User Manual