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Global Fever Panel Instructions for Use

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Global Fever Panel Instructions for Use DFA2-ASY-0004 BioFire ® Global Fever Panel Instructions for Use The Symbols Glossary is provided on Page 42 of this booklet. For In Vitro Diagnostic Use Manufactured by BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107 USA TABLE OF CONTENTS INTENDED USE ................................................................................................................................ 1 SUMMARY AND EXPLANATION OF THE TEST ............................................................................ 1 Summary of Detected Organisms ................................................................................................. 2 Bacteria ...................................................................................................................................... 2 Viruses ....................................................................................................................................... 2 Protozoa ..................................................................................................................................... 2 PRINCIPLE OF THE PROCEDURE .................................................................................................. 4 MATERIALS PROVIDED .................................................................................................................. 5 MATERIALS REQUIRED BUT NOT PROVIDED ............................................................................. 5 WARNINGS AND PRECAUTIONS ................................................................................................... 5 General Precautions ..................................................................................................................... 5 Safety Precautions ........................................................................................................................ 5 Laboratory Precautions ................................................................................................................. 6 Precaution Related to Public Health ............................................................................................. 7 REAGENT STORAGE, HANDLING, AND STABILITY .................................................................... 7 SAMPLE REQUIREMENTS .............................................................................................................. 8 PROCEDURE .................................................................................................................................... 8 Step 1: Prepare Pouch .................................................................................................................. 9 Step 2: Hydrate Pouch .................................................................................................................. 9 Step 3: Prepare Sample Mix ....................................................................................................... 10 Step 4: Load Sample Mix ............................................................................................................ 11 Step 5: Run Pouch ...................................................................................................................... 12 QUALITY CONTROL ....................................................................................................................... 13 Process Controls ......................................................................................................................... 13 Monitoring Test System Performance ......................................................................................... 13 External Controls ......................................................................................................................... 13 INTERPRETATION OF RESULTS .................................................................................................. 14 Assay Interpretation .................................................................................................................... 14 Organism Interpretation .............................................................................................................. 15 Leptospira spp. Reporting ........................................................................................................ 16 Chikungunya virus Reporting ................................................................................................... 16 Dengue virus Reporting ........................................................................................................... 16 Plasmodium Reporting ............................................................................................................. 16 BioFire Global Fever Panel Test Report ..................................................................................... 18 Results Explanation and Required Actions ................................................................................. 20 CLEANING MATERIALS ................................................................................................................ 21 DECONTAMINATION PROCEDURES ........................................................................................... 21 Pouch Loading Station Decontamination .................................................................................... 21 BioFire® Global Fever Panel - Instructions for Use i BioFire Defense, LLC Decontamination Related to Pouch Leakage .............................................................................. 21 Instrument Decontamination ....................................................................................................... 22 Pouch Loading Chamber Decontamination ............................................................................. 22 Instrument Exterior Decontamination ...................................................................................... 22 Decontamination of Bench Tops and Other Areas ..................................................................... 22 Check Function of Decontaminated Instrument .......................................................................... 22 Check for Environmental Contamination .................................................................................... 23 LIMITATIONS .................................................................................................................................. 24 EXPECTED VALUES ...................................................................................................................... 25 PERFORMANCE CHARACTERISTICS ......................................................................................... 27 Clinical Performance ................................................................................................................... 27 Limit of Detection......................................................................................................................... 29 Analytical Reactivity (Inclusivity) ................................................................................................. 31 Analytical Reactivity (Cross-Reactivity and Exclusivity).............................................................. 35 Reproducibility ............................................................................................................................. 38 Interference ................................................................................................................................. 39 APPENDIX A ................................................................................................................................... 42 Symbols Glossary ....................................................................................................................... 42 APPENDIX B ................................................................................................................................... 43 Contact and Legal Information .................................................................................................... 43 Revision History .......................................................................................................................... 43 APPENDIX C ................................................................................................................................... 44 References .................................................................................................................................. 44 BioFire® Global Fever Panel - Instructions for Use ii BioFire Defense, LLC INTENDED USE The BioFire® Global Fever Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray® 2.0 system. The BioFire Global Fever Panel detects and identifies selected bacterial, viral, and protozoan nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute febrile illness or recent acute febrile illness and known or suspected exposure to the following target pathogens: Leptospira spp., chikungunya virus, dengue virus (serotypes 1, 2, 3 and 4), and Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale). Evaluation for more common causes of acute febrile illness (e.g., infections of the upper and lower respiratory tract or gastroenteritis, as well as non-infectious causes) should be considered prior to evaluation with this panel. Results are meant to be used in conjunction with other clinical, epidemiologic, and
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