Table Of Contents; Contents - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

Contents

Customer and technical support ............................................................................. 2
Contents ...................................................................................................................... 3
Table of symbols ......................................................................................................... 5
1 Information about the DiagCORE
1.1 Product name and intended use .................................................................... 6
1.2 Package contents .............................................................................................. 7
1.3 Storage and expiration date ............................................................................ 7
2 Safety information ......................................................................................... 8
3 General background .................................................................................... 9
3.1 DiagCORE Respiratory Panel 2 Cartridge description ................................ 9
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3.2 Detected pathogens ....................................................................................... 10
3.3 Description of the procedure ......................................................................... 12
3.4 Sample collection and cartridge loading .................................................... 13
3.5 Sample preparation, nucleic acid amplification, and detection ............ 13
4 Required materials and equipment that are not provided ..................... 15
5 Procedure for dry swab samples ............................................................... 16
5.1 Sample collection, transport, and storage ................................................... 16
5.2 Loading a sample into the DiagCORE
5.3 Starting the DiagCORE
5.4 Running a test ................................................................................................... 19
6 Procedure for transport medium liquid samples ...................................... 25
6.1 Sample collection, transport, and storage ................................................... 25
6.2 Loading a sample into the DiagCORE
6.3 Starting the DiagCORE
6.4 Running a test ................................................................................................... 29
7 Internal control ............................................................................................ 34
8 Interpretation of results ............................................................................... 35
8.1 Viewing results ................................................................................................... 35
8.2 Result interpretation ......................................................................................... 40
8.3 Internal Control interpretation ........................................................................ 41
Respiratory Panel 2 ............................. 6
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Respiratory Panel 2 Cartridge ... 16
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Analyzer .................................................................. 19
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Respiratory Panel 2 Cartridge ... 25
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Analyzer .................................................................. 28
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DiagCORE Respiratory Panel 2 Instructions for Use 3