DiagCORE Respiratory Panel 2 Instructions for Use 59
12.7
Carryover
A carryover study was performed to evaluate the potential occurrence of cross contamination
between consecutive runs when using the DiagCORE
®
Respiratory Panel 2 on the DiagCORE
®
Analyzer.
Samples of simulated NPS matrix with alternating high-positive and negative samples were
conducted on one DiagCORE
®
Analyzer.
No carryover between samples was observed in the DiagCORE
®
Respiratory Panel 2.
12.8
Reproducibility
To prove reproducible performance of the DiagCORE
®
Respiratory Panel 2 on 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
Strain
Influenza A H1
A/New Jersey/8/76
Influenza A H3
A/Virginia/ATCC6/2012
Influenza A H1N1 pdm
A/SwineNY/03/2009
Influenza B
B/FL/04/06
Cor 229E
n/a
Cor OC43
n/a
Cor NL63
n/a
Cor HKU1
n/a
Parainfluenza Virus 1
C35
Parainfluenza Virus 2
Greer
Parainfluenza Virus 3
C 243
Parainfluenza Virus 4a
M-25
Rhinovirus
A16
Enterovirus
/US/IL/14-18952 (enterovirus D68)
Adenovirus
RI-67 (adenovirus E4)
RSV B
9320
hMPV
Peru6-2003 (type B2)
Bocavirus
Clinical sample
Mycoplasma pneumoniae
M129-B7 (type 1)
Clamydophila pneumoniae
TW183
Legionella pneumophila
CA1
Bordetella pertussis
I028