FilmArray RFIT-ASY-0094 Bio Threat Panel User Guide

FilmArray RFIT-ASY-0094 Bio Threat Panel

Product Information

• Product Name: Wells RFIT-ASY-0094
• Intended Use: Environmental Surveillance and Research
• Storage: Components from this kit should not be stored or used with any other kit. Discard any extra components from the kit after all pouches have been used

Safety Precautions

• To avoid contamination, clean work area and always wear gloves.
• Work according to appropriate biosafety conditions while manipulating potentially infectious samples.

Product Usage Instructions

Step 1: Prepare Pouch

1. Insert the pouch into the Pouch Loading Station.
2. Place the Sample Injection Vial into the red well.
3. Place the Hydration Injection Vial into the blue well.

Step 2: Hydrate Pouch

1. Twist off the Hydration Injection Vial, leaving the blue plastic cover in the Pouch Loading Station.
2. Insert the Hydration Injection Vial into the pouch hydration port.
3. Forcefully push down to puncture the seal and verify that the Hydration Solution has been drawn into the pouch.

Step 3: Prepare Sample Mix
Add Sample Buffer:

1. Hold the Sample Buffer Tube so that the tip is facing up.
2. Gently pinch the textured plastic tab on the side of the tube until the seal snaps. Do not touch the tip of the tube.
3. Invert the tube over the Sample Injection Vial.
4. Dispense Sample Buffer by squeezing the liquid-filled end using a slow, forceful squeeze, followed by a 2nd squeeze. Avoid excessive foaming by not squeezing the tube additional times.

For Liquid Samples (including Air-into-PBS / Dry Filter / Liquid)

1. After collecting the liquid sample, use the Transfer Pipette to draw filter wash or liquid to the 3rd line (approx. 300 uL) and add it to the Sample Injection Vial.
2. Tightly close the lid of the Sample Injection Vial and mix the sample by gently inverting it 3 times.
3. Return the Sample Injection Vial to the red well of the Pouch Loading Station.

Step 4: Load Sample Mix

1. With the Sample Injection Vial in the Pouch Loading Station, twist to loosen it from the red plastic cover and pause for 5 seconds.
2. Lift the Sample Injection Vial from the red plastic cover and insert it into the Sample port.
3. Forcefully push down to puncture the seal and verify that the Sample Mix has been drawn into the pouch.

Step 5: Run Pouch
Follow the instructions on the screen for starting a test. Select BT PBS protocol.

Step 6: Review Report
The test results will be displayed on the screen, showing information about the sample and the detected organisms.

Specifications

• Bacteria:
  • Bacillus anthracis
  • Yersinia pestis

FAQ

1. Q: Can the components from this kit be used with other kits?
   A: No, the components from this kit should not be stored or used with any other kit.

2. Q: How should I avoid contamination while using this product?
   A: Clean your work area and always wear gloves to avoid contamination.

3. Q: What should I do with extra components from the kit?
   A: Discard any extra components from the kit after all pouches have been used.

FilmArray® BioThreat Panel Quick Guide For use with BioFire® FilmArray®

2.0 System

• For Environmental Surveillance and Research Use Only. Not for use in diagnostic procedures
• NOTE: To avoid contamination, clean work area and always wear gloves.
• Work according to appropriate biosafety conditions while manipulating potentially infectious samples.
• NOTE: Components from this kit should not be stored or used with any other kit.
• Discard any extra components from the kit after all pouches have been used.
• Materials required for powder and surface swab but not provided
• NOTE: BioFire® FilmArray® 2.0 Instrument should be powered on and ready for use prior to pouch preparation.

STEP 1: Prepare Pouch

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

STEP 2: Hydrate Pouch

• Twist off Hydration Injection Vial, leaving blue plastic cover in Pouch Loading Station, and insert into pouch hydration port.
• Forcefully push down to puncture seal and verify that Hydration Solution has been drawn into pouch.

STEP 3: Prepare Sample Mix

Add Sample Buffer

• Hold the Sample Buffer Tube so that the tip is facing up.

• Gently pinch the textured plastic tab on the side of the tube until the seal snaps
  NOTE: Do not touch the tip of the tube.

• Invert the tube over the Sample Injection Vial.

• Dispense Sample Buffer by squeezing the liquid-filled end using a slow, forceful squeeze, followed by a 2nd squeeze.
  NOTE: Squeezing the tube additional times will generate excessive foaming, which should be avoided.

For Liquid Samples (including Air-into-PBS / Dry Filter / Liquid)

• After collecting the liquid sample, use Transfer Pipette to draw filter wash or liquid to the 3rd line (approx. 300 uL) and add to Sample Injection Vial.
• Tightly close the lid of the Sample Injection Vial and mix sample by gently inverting 3 times.
• Return the Sample Injection Vial to the red well of the Pouch Loading Station.

STEP 3: Prepare Sample Mix (cont.)

For Surface Swab Samples (including Powder / Surface):

• After collecting sample, place the tip of the swab into the Sample Injection Vial and swirl for 5 seconds.

• Break the swab handle at the molded break point, leaving the tip of the swab in the Sample Injection Vial.
  NOTE: If the swab handle does not have a molded break point, cut the tip of the swab with clean scissors, leaving the tip of the swab in the Sample Injection Vial.

• Discard the handle in an appropriate waste container.

• Tightly close lid of Sample Injection Vial and mix sample by gently inverting 3 times.

• Return Sample Injection Vial to red well of Pouch Loading Station.

STEP 4: Load Sample Mix

• With Sample Injection Vial in the Pouch Loading Station, twist to loosen it from the red plastic cover and pause for 5 seconds.
• Lift Sample Injection Vial from red plastic cover and insert into Sample port.
• Forcefully push down to puncture seal and verify that Sample Mix has been drawn into pouch.

STEP 5: Run Pouch

• Follow instructions on screen for starting a test.
• NOTE: Select BT PBS protocol.

Step 6: Review Report

1. Run Summary – Displays information about the sample. Internal Controls:
   • If ‘Pass’, results are valid.
   • If ‘Fail’ or ‘Invalid’, RETEST SAMPLE.
2. Result Summary – Displays the test results for each organism.
   • ‘Detected’: Lists names of any detected organisms.
   • ‘Not Detected’: Lists names of organisms that were not detected.
   • ‘N/A’, pathogen was not reported. Refer to Instruction Booklet for more information.
3. Run Details – Displays information about the pouch, protocol,  run status, operator, instrument, serial number, and lot number. Run Status:
   • If ‘Completed’, run is complete.
   • If ‘Incomplete’, ‘Aborted’, or any other error message, RETEST SAMPLE.

• NO TE: Refer to the FilmArray BioThreat Panel 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

References

• Safeguarding Humanity - BioFire Defense

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