Information About The Diagcore ® Respiratory Panel 2; Product Name And Intended Use - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

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Information about the DiagCORE Respiratory
®
Panel 2

1.1 Product name and intended use

The DiagCORE Respiratory Panel 2 is a qualitative test intended for analyzing nasopharyngeal
®
swab (NPS) samples taken from patients suspected of respiratory infection for the presence of viral
or bacterial nucleic acids. The DiagCORE Respiratory Panel 2 is able to accept both dry swabs
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and transport medium liquid samples. The assay is designed for use with the DiagCORE Analyzer
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for integrated nucleic acid extraction and multiplex, RT-real-time PCR detection.
The following pathogens can be detected and differentiated with the DiagCORE ® Respiratory
Panel 2: Influenza A, Influenza A subtype H1N1/2009, Influenza A subtype H1, Influenza A subtype
H3, Influenza B, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43,
Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Respiratory
Syncytial virus A/B, human Metapneumovirus A/B, Adenovirus, Bocavirus, Rhinovirus/Enterovirus,
Mycoplasma pneumoniae, Legionella pneumophila and Bordetella pertussis.
The results from the DiagCORE Respiratory Panel 2 must be interpreted within the context of all
®
relevant clinical and laboratory findings.
Assay performance characteristics have been established only for individuals who have shown
respiratory symptoms.
The DiagCORE Respiratory Panel 2 is intended for professional use only and is not intended for self-
®
testing.
For in vitro diagnostic use.
6 DiagCORE Respiratory Panel 2 Instructions for Use