General Background; Diagcore ® Respiratory Panel 2 Cartridge Description - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

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General background

3.1 DiagCORE Respiratory Panel 2 Cartridge description
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The DiagCORE Respiratory Panel 2 Cartridge is a disposable plastic device that allows
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performance of fully automated molecular assays for the detection of respiratory pathogens. Main
features of the DiagCORE
dry swabs (Copan FLOQSwabs, Ref. 503CS01) and transport medium liquid samples, hermetical
containment of the pre-loaded reagents necessary for testing, and true walk-away operation. All
sample preparation and assay testing steps are performed within the cartridge.
All reagents required for the complete execution of a test run are pre-loaded and self-contained
in the DiagCORE ® Respiratory Panel 2 Cartridge. The user does not need to come in contact with
and/or manipulate any reagents. During the test, reagents are handled in the Analytical Module
of the DiagCORE Analyzer by pneumatically-operated microfluidics and make no direct contact
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with the Analyzer actuators. The Analyzer houses air filters for both incoming and outgoing air,
further safeguarding the environment. After testing, the cartridge stays hermetically closed at all
times, greatly enhancing its safe disposal.
Within the cartridge, multiple steps are automatically performed in sequence using pneumatic
pressure to transfer samples and fluids via the transfer chamber to their intended destinations.
After the DiagCORE Respiratory Panel 2 Cartridge containing the sample is introduced into the
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Analyzer, the following assay steps occur automatically:
Resuspension of internal control
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Cell lysis using mechanical and/or chemical means
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Membrane-based nucleic acid purification
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Mixing of the purified nucleic acid with lyophilized master mix reagents
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Transfer of defined aliquots of eluate/master mix to different reaction chambers
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Performance of RT-real-time, multiplex PCR testing within each reaction chamber. An increase
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in fluorescence, indicating detection of the target analyte, is detected directly within each
reaction chamber.
Respiratory Panel 2 Cartridge include compatibility with the respiratory
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DiagCORE Respiratory Panel 2 Instructions for Use 9