FilmArray® Gastrointestinal Panel(Injection Vials)

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

Step 1: Prepare Pouch q Insert pouch into Pouch Loading Station. q Place Sample Injection Vial into red well. q Place Hydration Injection Vial into blue well.

x3

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

Step 2: Hydrate Pouch q Unscrew Hydration Injection Vial, leaving cap in Pouch Loading Station, and insert into pouch hydration port.

q Forcefully push down to puncture seal and wait as Hydration Solution is drawn into pouch.

x3

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

Step 3: Prepare Sample Mix q Add Sample Buffer to Sample Injection Vial:• Invert Sample Buffer Ampoule so that tip is facing up. Note: Do not touch the tip of the ampoule.• Firmly pinch textured plastic tab on side of ampoule until seal snaps.• With the tip facing down, dispense Sample Buffer into Sample Injection Vial using a slow, forceful squeeze, followed by a 2nd squeeze. Avoid generating excessive bubbles.

q Thoroughly mix stool specimen in transport media. q Using transfer pipette, draw up specimen to 2nd line. q Add to Sample Injection Vial. q Tightly close lid of Sample Injection Vial. q Mix sample by gently inverting Sample Injection Vial 3 times. q Return Sample Injection Vial to red well of Pouch Loading Station.

Warning: The Sample Buffer is harmful if swallowed, can cause serious eye damage and/or skin irritation.

x3

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

x3

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

x3

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

x3

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

x3Step 4: Load Sample Mix q Unscrew Sample Injection Vial from cap. q Pause for 3-5 seconds, then remove Sample Injection Vial, leaving cap in Pouch Loading Station.

q Insert Sample Injection Vial into pouch sample port. q Forcefully push down to puncture seal. q Wait as Sample Mix is drawn into pouch.

x3

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

BioFire Diagnostics, LLC

390 Wakara Way

Salt Lake City, Utah 84108

USA

FLM1-SUB-0065

0:05

Step 5: Run Pouch q Follow instructions on computer for initiating a test. q The pouch will click into place when properly seated.

Note: If the pouch does not insert easily, ensure that the lid is opened completely.

FilmArray™ Panel

3. ' Detected', pathogen was detected4. 'Not Detected', pathogen was not

detected5. ' ø N/A', pathogen was not reported.

Refer to Instruction Booklet for more information.

TM

Example

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5.

3.

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6.

The Run Summary Section displays information about the sample and a summary of the control and test results.

1. Detected:• Names of any detected pathogens• If “None”, no pathogens were detected

• If “ Invalid”, RETEST SAMPLE 2. Controls:

• If “Passed”, results are valid• If “ Failed”, RETEST SAMPLE• If “ Invalid”, RETEST SAMPLE

The Results Summary Section lists the test results for each pathogen targeted by the Respiratory Panel.

6. Run Status: If Completed, run is complete.

If Incomplete, Aborted, Instrument Communication Error, Instrument Error or Software Error, RETEST SAMPLE.

Note: If repeated “Error” messages are obtained contact BioFire Diagnostics, the local bioMérieux sales representative, or an authorized distributor.

The Run Details Section displays information about the pouch, instrument, run status and operator.

Understanding the FilmArray Run Report

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Manufactured by:BioFire Diagnostics, LLC390 Wakara Way, Salt Lake City, UT 84108, USABioFire is a subsidiary 100% owned by bioMérieux.

www.biofiredx.com

bioMérieux S.A.69280 Marcy I’EtoileFranceTel.: +33 (0) 4 78 87 20 00Fax: +33 (0) 4 78 87 20 90

www.biomerieux.com

The purchase of this product includes a limited, non-transferable license under speci� c claims of one or more US patents listed on the BioFire Diagnostics website (http://www.bio� redx.com/LegalNotices/) owned by BioFire and/or the Research Foundation of The University of Utah. The blue logo, BioFire and FilmArray logos, and BIOMÉRIEUX, BIOFIRE, and FILMARRAY are used, pending, and/or registered trademarks belonging to bioMérieux or BioFire or one of their subsidiaries or companies. Document and/or picture not legally binding. Modi� cations can be made without prior notice. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of bioMérieux / BioFire Diagnostics.

TM®