4 DiagCORE Respiratory Panel 2 Instructions for Use
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