Sample Stability - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

Reproducibility testing demonstrated that the DiagCORE® Respiratory Panel 2 running in the
DiagCORE
multiple runs, on multiple days, and with various operators using different DiagCORE
multiple lots of cartridges.

12.9 Sample Stability

A sample stability study was executed to analyze storage conditions for clinical samples to be
tested with the DiagCORE® Respiratory Panel 2. Simulated NPS sample matrix (cultured human
cells in Copan UTM) was spiked with viral or bacterial culture material of low concentration (e.g. 3x
LoD). Samples were stored at the following conditions for testing:
 15 ˚C to 25 ˚C for 4 hours
 2 ˚C to 8 ˚C for 3 days
 -15 ˚C to -25 ˚C for 30 days
 -70 ˚C to -80 ˚C for 30 days
All pathogens were successfully detected at the different storage temperatures and durations
concluding that samples were stable at the indicated storage conditions and durations.
62 DiagCORE Respiratory Panel 2 Instructions for Use
Analyzer provides highly reproducible test results when the same samples are tested in
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Analyzers and
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