STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual page 50

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The overall Clinical Sensitivity of the dry swab specimen was found to be 98. 8% (95% confidence
interval 96.4%-99.6%). The overall Clinical Specificity for the dry swab specimen was 98.1% % (95%
confidence interval 94.6%-99.4%).
The dry swab study results supported the ability to test swabs entered directly in the DiagCORE
Respiratory Panel 2 cartridges as dry swabs. The dry swab specimen was found to show excellent
concordance with the UTM specimen, as best demonstrated by the overall agreement between
the UTM specimen and dipped swabs, which was 98.5% (95% confidence interval 97%-99.5 %).
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DiagCORE Respiratory Panel 2 Instructions for Use

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