Filmarray® Blood Culture Identification Panel Quick Guide
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® FilmArray Blood Culture Identification Panel Quick Guide Testing on the FilmArray should be performed within 8 hours of the positive reading from a continuously monitoring blood culture instrument. To avoid contamination always wear gloves and work behind a protective shield. Step 1: Prepare Pouch Once sample is ready for testing, remove pouch from packaging. Insert pouch into Pouch Loading Station. Place Sample Buffer vial into red well. OR Place Hydration Solution vial into blue well. Step 2: Hydrate Pouch Draw 1 mL of Hydration Solution into Hydration Syringe. If bubbles are present in liquid, leave syringe tip in vial and gently tap side of syringe, releasing bubbles to float to surface. Insert Hydration Syringe tip into hydration port of pouch located OR directly below blue arrow. Holding the barrel of the Hydration Syringe, forcefully push down to puncture port seal. DO NOT PUSH THE SYRINGE PLUNGER. FilmArray Wait as Hydration Solution is drawn into pouch. ™ Panel Note: See FilmArray Operator's Manual Troubleshooting section if pouch fails to hydrate. OR Step 3: Prepare Sample Mix Use a 28 gauge needle to withdraw 0.1 mL of sample from blood culture bottle. Transfer sample to Sample Buffer vial. Gently mix up and down using Transfer Pipette. Note: For alternate workflow, see package insert. FilmArray ™ Panel Step 4: Load Sample Mix OR Draw 0.3 mL of Sample Mix using Sample Loading Syringe. Insert Sample Loading Syringe tip into sample port of pouch FilmArray located directly below red arrow. ™ Panel Holding the barrel of the syringe, forcefully push down to puncture port seal. DO NOT PUSH THE SYRINGE PLUNGER. Wait as Sample Mix is drawn into pouch. Step 5: Run Pouch Follow instructions on software screen. FilmArray The pouch will click into place when properly seated. ™ Panel Note: If the pouch does not insert easily, ensure that the lid is opened completely. ® BioFire Diagnostics, LLC | 390 Wakara Way, Salt Lake City, Utah 84108, USA | 1-801-736-6354 ® FilmArray Blood Culture Identification Panel Quick Guide TM BCID Panel The Run Summary Section displays information Run Summary about the sample and a summary of the control and Sample ID: 8017366354 Run Date: 19 Mar 2012 3:36 PM test results. 1. Organisms Staphylococcus 3. Controls: Passed Detected: Staphylococcus aureus 1. Organisms Detected: Applicable • Names of any detected organisms 2. • If "None", no organisms were detected Antimicrobial mecA - Detected Resistance Genes: • If " Invalid", RETEST SAMPLE 2. Applicable Antimicrobial Resistance Genes: Displays results for antimicrobial resistance gene(s) associated with detected organism(s). Results Summary - Interpretations 3. Controls: Antimicrobial Resistance Genes • If "Passed", results are valid √ Detected mecA (methicillin-resistance gene) • If " Failed" or " Invalid", RETEST SAMPLE 4. Ø N/A vanA/B (vancomycin-resistance genes) Ø N/A KPC (carbapenem-resistance gene) NOTE: Antimicrobial resistance can occur via multiple mechanisms. A Not Detected result for the FilmArray antimicrobial resistance gene assays does not indicate antimicrobial susceptibility. Subculturing is required for species identification and susceptibility testing of isolates. Gram Positive Bacteria The Results Summary-Interpretations Section Not Detected Enterococcus lists the test results for each organism or antimicrobial Not Detected Listeria monocytogenes resistance gene targeted by the Blood Culture 5. √ Detected Staphylococcus Identification Panel. √ Detected Staphylococcus aureus 4. If "N/A", antimicrobial resistance gene was not Not Detected Streptococcus 6. reported because an organism associated with Not Detected Streptococcus agalactiae (Group B) the gene was not detected Not Detected Streptococcus pneumoniae Not Detected Streptococcus pyogenes (Group A) 5. If "Detected", organism or antimicrobial Gram Negative Bacteria resistance gene was detected Not Detected Acinetobacter baumannii 6. If "Not Detected", organism or antimicrobial Not Detected Enterobacteriaceae resistance gene was not detected Not Detected Enterobacter cloacae complex Not Detected Escherichia coli If “ Invalid”, RETEST SAMPLE Not Detected Klebsiella oxytoca Not Detected Klebsiella pneumoniae Note: If repeated "Invalid" results are obtained, Not Detected Proteus contact BioFire Diagnostics, the local bioMérieux Not Detected Serratia marcescens Not Detected Haemophilus influenzae sales representative, or an authorized distributor. Not Detected Neisseria meningitidis Not Detected Pseudomonas aeruginosa The Run Details Section displays information about Yeast the pouch, instrument, run status, and operator. Not Detected Candida albicans Not Detected Candida glabrata 7. Run Status: If Completed, run is complete. Not Detected Candida krusei If "Incomplete", "Aborted", "Instrument Not Detected Candida parapsilosis Communication Error", "Instrument Error", or Not Detected Candida tropicalis "Software Error", RETEST SAMPLE : If repeated "Error" messages are obtained, Note Run Details contact BioFire Diagnostics, the local bioMérieux Pouch: BCID Panel v2.0 Protocol: BC v 2.1 sales representative, or an authorized distributor. 7. Run Status: Completed Operator: Operator Serial No.: 00169044 Instrument: ITI FA "FA1187" Lot No.: 120228B ® © Copyright 2015 BioFire Diagnostics, LLC. All rights reserved. RFIT-PRT-0056-04 BioFire Diagnostics, LLC | 390 Wakara Way, Salt Lake City, Utah 84108, USA | 1-801-736-6354 RFIT-ASY-0114 RFIT-ASY-0109 FilmArray® Blood Culture Identification (BCID) Panel Instruction Booklet For use with the syringe-based loading system Customer and Technical Support for U.S. Customers Reach Us on the Web Reach Us by Phone http://www.BioFireDX.com 1-800-735-6544 – Toll Free (801) 736-6354 – Utah Reach Us by E-mail [email protected] Reach Us by Fax Reach Us by Mail (801) 588-0507 390 Wakara Way Salt Lake City, UT 84108 USA Customer and Technical Support outside of the U.S. Contact your local sales representative or distributor for technical support BioFire Diagnostics, LLC 390 Wakara Way Qarad b.v.b.a Cipalstraat 3 Salt Lake City, UT 84108 B-2440 Geel, USA Belgium © Copyright 2007–2015, BioFire Diagnostics, LLC. All rights reserved. RFIT-PRT-0101-04 February 2015 The information contained in this document is subject to change without 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 BioFire Diagnostics, LLC. FilmArray Software, Detector, and Metacall software modules © 2002–2015 BioFire Diagnostics, LLC. BioFire Diagnostics, BioFire, the BioFire logo, FilmArray and LCGreen are trademarks of BioFire Diagnostics, LLC or BioFire Defense, LLC and are registered trademarks in the United States. All other names of products and brands appearing in this manual are trademarks or registered trademarks of their respective owners. The purchase of this product includes a limited, nontransferable license under specific claims of one or more U.S. patents as listed on BioFire Diagnostics’ Web site (http://www.biofiredx.com/LegalNotices/) and owned by BioFire and the University of Utah Research Foundation. BioFire Diagnostics, LLC FilmArray BCID Panel CE-IVD Instruction Booklet i TABLE OF SYMBOLS The following symbols can be found on FilmArray BCID Panel Kit components or throughout this Instruction Booklet. Use the definitions below as a guideline to interpreting the symbols. Table of Symbols Expiry Date Manufacturer Catalog Number YYYY-MM-DD Consult Storage Temperature Lot Number Instructions for Use Limitations European Union Contains Sufficient Serial Number Conformity n For <n> Tests In vitro Diagnostic Keep Away from Do Not Reuse Medical Device Sunlight Acute toxicity, cat. Serious eye Do Not Use if 4 & Skin irritation, damage, cat. 1 Package is Damaged cat. 2 BioFire Diagnostics, LLC FilmArray BCID Panel CE-IVD Instruction Booklet ii TABLE OF CONTENTS TABLE OF SYMBOLS ................................................................................................................................................... II TABLE OF CONTENTS ................................................................................................................................................ III NAME AND INTENDED USE .........................................................................................................................................5 FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL ......................................................................................................... 5 SUMMARY AND EXPLANATION OF THE TEST ...............................................................................................................5 BACKGROUND OF TARGETED ORGANISMS ................................................................................................................................... 6 PRINCIPLE OF THE PROCEDURE ................................................................................................................................................. 11 MATERIALS PROVIDED ............................................................................................................................................. 12 MATERIALS REQUIRED BUT NOT PROVIDED .............................................................................................................. 13 WARNINGS AND PRECAUTIONS ...............................................................................................................................