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Biofire COVID-19 Test V1.1 Instructions for Use

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Biofire COVID-19 Test V1.1 Instructions for Use ® BioFire COVID-19 Test Master Table of Contents ® 1. BioFire COVID-19 Test v1.0 Instructions for Use (also contains ® BioFire COVID-19 Test External Control Kit v1.0 (+) Instructions for Use) ® 2. BioFire COVID-19 Test v1.0 Quick Guide ® 3. BioFire COVID-19 Test External Control Kit v1.0 Quick Guide ® 4. BioFire COVID-19 Test v1.1 Instructions for Use ® 5. BioFire COVID-19 Test v1.1 Upper Respiratory Quick Guide ® 6. BioFire COVID-19 Test v1.1 Lower Respiratory Quick Guide ® ™ 7. BIOFIRE SHIELD Control Kit for the BioFire COVID-19 Test v1.1 Instructions for Use ® 8. BIOFIRE SHIELD™ Control Kit for the BioFire COVID-19 Test v1.1 Quick Guide BioFire Defense, LLC Salt Lake City, Utah, USA BioFire® COVID-19 Test v1.0 Instructions for Use (also contains BioFire® COVID-19 Test External Control Kit v1.0 Instructions for Use) BioFire® COVID-19 Test v1.0 Quick Guide BioFire® COVID-19 Test External Control Kit v1.0 Quick Guide BioFire Defense, LLC Salt Lake City, Utah, USA 423745 (6 pack test) 423744 (30 pack test) 423748 (6 pack (+) control) BioFire ® COVID-19 Test Instructions for Use v1.0 The Symbols Glossary is provided on Page 39 of this booklet. For in vitro diagnostic use under an Emergency Use Authorization (EUA) only Please visit us at www.biofiredefense.com/covid-19test Manufactured by BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107 USA TABLE OF CONTENTS TABLE OF CONTENTS ..................................................................................................................... i INTENDED USE ................................................................................................................................ 1 SUMMARY AND EXPLANATION OF THE TEST ............................................................................ 1 PRINCIPLE OF THE PROCEDURE ................................................................................................. 2 MATERIALS PROVIDED .................................................................................................................. 3 MATERIALS REQUIRED BUT NOT PROVIDED ............................................................................. 3 ADDITIONAL AVAILABLE MATERIALS ......................................................................................... 3 WARNINGS AND PRECAUTIONS ................................................................................................... 4 General Precautions ..................................................................................................................... 4 Safety Precautions ........................................................................................................................ 5 Laboratory Precautions ................................................................................................................. 5 Precaution Related to Public Health Reporting ............................................................................ 6 REAGENT STORAGE, HANDLING, AND STABILITY .................................................................... 7 SAMPLE REQUIREMENTS .............................................................................................................. 7 ® BIOFIRE COVID-19 TEST PROCEDURE ...................................................................................... 7 Preparing Upper Respiratory Specimens for Pooling ................................................................... 8 Step 1: Prepare Pouch .................................................................................................................. 8 Step 2: Hydrate Pouch .................................................................................................................. 9 Step 3: Prepare Sample Mix ......................................................................................................... 9 Step 4: Load Sample Mix ............................................................................................................ 10 Step 5: Run Pouch ...................................................................................................................... 11 BioFire FilmArray 2.0 ............................................................................................................... 11 BioFire FilmArray Torch ........................................................................................................... 12 QUALITY CONTROL ...................................................................................................................... 13 Process Controls ......................................................................................................................... 13 Monitoring Test System Performance ........................................................................................ 13 ® BIOFIRE COVID-19 TEST v1.0 EXTERNAL CONTROLS ........................................................... 14 External Controls ........................................................................................................................ 14 ® BioFire COVID-19 Test v1.0 External Control Procedure (+) ................................................... 15 ® BioFire COVID-19 Test v1.0 External Control Procedure (-) .................................................... 16 INTERPRETATION OF RESULTS ................................................................................................. 17 Assay Interpretation .................................................................................................................... 17 Organism Interpretation .............................................................................................................. 18 SARS-CoV-2 ........................................................................................................................... 18 ® BioFire COVID-19 Test Report ................................................................................................. 19 Run Summary .......................................................................................................................... 20 BioFire Defense, LLC BioFire® COVID-19 Test v1.0 – Instructions for Use i Result Summary ...................................................................................................................... 20 Run Details .............................................................................................................................. 22 Change Summary .................................................................................................................... 22 Analysis of BioFire COVID-19 Test v1.0 External Control (+) Assays ....................................... 22 LIMITATIONS .................................................................................................................................. 24 CONDITIONS OF AUTHORIZATION FOR THE LABORATORY .................................................. 25 PERFORMANCE CHARACTERISTICS ......................................................................................... 27 Clinical Summary ........................................................................................................................ 27 Testing of Archived Clinical Specimens ...................................................................................... 27 Testing of Contrived Clinical Specimens .................................................................................... 28 Testing of Pooled Clinical Specimens ........................................................................................ 29 Limit of Detection ........................................................................................................................ 30 FDA SARS-CoV-2 Reference Panel Testing .............................................................................. 30 Analytical Reactivity (in silico) ..................................................................................................... 31 Inclusivity (in silico) .................................................................................................................. 31 Exclusivity (in silico) ................................................................................................................. 31 Analytical Specificity (Exclusivity) ............................................................................................... 32 Interference ................................................................................................................................. 34 SPECIMEN POOLING .................................................................................................................... 36 Pooling Implementation .............................................................................................................. 36 Pooling Monitoring ...................................................................................................................... 37 APPENDIX A ................................................................................................................................... 39 Symbols Glossary ....................................................................................................................... 39 APPENDIX B ................................................................................................................................... 40 Contact and Legal Information .................................................................................................... 40 Customer and Technical Support
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