Table of Contents
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9 Installing the Assay Definition File .............................................................. 42
10 Limitations of the procedure .................................................................... 44
11 Performance characteristics. Clinical Performance ............................. 46
12 Performance characteristics. Analytical Performance ......................... 51
12.1 Sensitivity (Limit of Detection) ......................................................................... 51
12.2 Assay Robustness .............................................................................................. 52
12.3 Exclusivity (Analytical Specificity) ................................................................... 52
12.4 Inclusivity (Analytical Reactivity) .................................................................... 54
12.5 Co-Infections ..................................................................................................... 57
12.6 Interfering Substances ..................................................................................... 58
12.7 Carryover ........................................................................................................... 59
12.8 Reproducibility .................................................................................................. 59
12.9 Sample Stability ................................................................................................ 62
13 References ................................................................................................. 63
14 Appendices ............................................................................................... 64
14.1 Disposal information ......................................................................................... 64
14.2 Declaration of conformity ............................................................................... 64
14.3 Glossary .............................................................................................................. 64
14.4 Trademarks and copyright .............................................................................. 65
14.5 Copyright, disclaimer, and warranty ............................................................. 65
14.6 Patent statement ............................................................................................. 65
14.7 Software license agreement .......................................................................... 65
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DiagCORE Respiratory Panel 2 Instructions for Use
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Table of Contents
