Internal Control Interpretation - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

 In case seasonal Influenza A H3 strain is detected by the DiagCORE
assay, two signals will be generated, one for Influenza A and a second one for H3 strain
and shown on the DiagCORE
 In case a pandemic Influenza A/H1N1/2009 strain is detected, two signals will be
generated, one for Influenza A and a second one for H1N1/2009 and shown on the
DiagCORE Analyzer screen.
®
For every other pathogen that can be detected with the DiagCORE
signal will be generated if the pathogen is present in the sample.

8.3 Internal Control interpretation

Controls result
Passed
Failed
Analyzer screen.
®
Explanation
The internal control amplified
successfully.
The internal control failed.
® Respiratory Panel 2
Respiratory Panel 2, only one
®
Action
The run was completed with success,
and all results are validated and can be
reported. Detected pathogens
reported as positive, and not detected
pathogens are reported as negative.
Positively detected pathogen(s) are
reported, but all negative results (tested
but not detected pathogen(s)) are
invalid.
Repeat the testing
DiagCORE Respiratory
®
Cartridge.
DiagCORE Respiratory Panel 2 Instructions for Use
are
using a new
Panel 2
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