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

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Internal control

The DiagCORE Respiratory Panel 2 Cartridge includes a full process Internal Control which is titered
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MS2 bacteriophage. The MS2 bacteriophage is a single-stranded RNA virus, and it is included in the
cartridge in dried form and is rehydrated upon sample loading. This internal control material verifies
all steps of the analysis process, including sample resuspension/homogenization, lysis, nucleic acid
purification, reverse transcription, and PCR.
A positive signal for the internal control indicates that all processing steps performed by the
DiagCORE Respiratory Panel 2 Cartridge were successful.
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A negative signal of the internal control does not negate any positive results for detected and
identified targets, but it does invalidate all negative results in the analysis. Therefore, the test should
be repeated if the internal control signal is negative.
34 DiagCORE Respiratory Panel 2 Instructions for Use