Carryover; Reproducibility - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

12.7 Carryover

A carryover study was performed to evaluate the potential occurrence of cross contamination
between consecutive runs when using the DiagCORE
Analyzer.
Samples of simulated NPS matrix with alternating high-positive and negative samples were
conducted on one DiagCORE
No carryover between samples was observed in the DiagCORE

12.8 Reproducibility

To prove reproducible performance of the DiagCORE
Analyzer, a set of selected samples composed of low concentrated analytes (3xLoD and 1xLoD)
and negative samples were tested. Samples were tested in replicates using different lots of
DiagCORE Respiratory Panel 2 cartridges and tests were executed on different DiagCORE
®
Analyzers by different operators on different days.
Table 1: List of respiratory pathogens tested in Reproducibility
Pathogen
Influenza A H1
Influenza A H3
Influenza A H1N1 pdm
Influenza B
Cor 229E
Cor OC43
Cor NL63
Cor HKU1
Parainfluenza Virus 1
Parainfluenza Virus 2
Parainfluenza Virus 3
Parainfluenza Virus 4a
Rhinovirus
Enterovirus
Adenovirus
RSV B
hMPV
Bocavirus
Mycoplasma pneumoniae
Clamydophila pneumoniae
Legionella pneumophila
Bordetella pertussis
Analyzer.
®
A/New Jersey/8/76
A/Virginia/ATCC6/2012
A/SwineNY/03/2009
B/FL/04/06
n/a
n/a
n/a
n/a
C35
Greer
C 243
M-25
A16
/US/IL/14-18952 (enterovirus D68)
RI-67 (adenovirus E4)
9320
Peru6-2003 (type B2)
Clinical sample
M129-B7 (type 1)
TW183
CA1
I028
® Respiratory Panel 2 on the DiagCORE
Respiratory Panel 2.
®
Respiratory Panel 2 on the DiagCORE
®
Strain
DiagCORE Respiratory Panel 2 Instructions for Use
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