Co-Infections - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

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12.5 Co-Infections

A Co-infections study was performed to verify that multiple DiagCORE
included in one nasopharyngeal swab sample can be detected by the DiagCORE
Panel 2.
High and low concentrations of different organisms were combined in one sample. Selection of
organisms was made based on relevance, prevalence and layout of the DiagCORE
Panel 2 cartridge (distribution of targets in different reaction chambers).
Analytes were spiked into simulated NPS sample matrix (cultured human cells in UTM) in high (50x
LoD concentration) and low concentrations (5x LoD concentration) and tested in different
combinations. Table below shows the combination of co-infections tested in this study.
Table 1. List of Co-infections combinations tested.
Pathogens
Influenza A/H3N2
Adenovirus C5
Influenza A/H3N2
Adenovirus C5
Parainfluenza 3
Influenza A/H1N1/2009
Parainfluenza 3
Influenza A/H1N1/2009
Respiratory Syncytial Virus A
Influenza B
Respiratory Syncytial Virus A
Influenza B
Adenovirus C5
Rhinovirus B, Type HRV-B14
Adenovirus C5
Rhinovirus B, Type HRV-B14
Respiratory Syncytial Virus A
Rhinovirus B, Type HRV-B14
Respiratory Syncytial Virus A
Rhinovirus B, Type HRV-B14
Respiratory Syncytial Virus B
Bocavirus
Respiratory Syncytial Virus B
Bocavirus
Coronavirus OC43
Rhinovirus B, Type HRV-B14
Coronavirus OC43
Rhinovirus B, Type HRV-B14
Human Metapneumovirus B2
Parainfluenza 1
Human Metapneumovirus B2
Parainfluenza 1
Coronavirus 229E
Respiratory Syncytial Virus A
Coronavirus 229E
Respiratory Syncytial Virus A
Respiratory Syncytial Virus B
Coronavirus NL63
Respiratory Syncytial Virus B
Coronavirus NL63
Strain
A/Virginia/ATCC6/2012
Adenoid 75
A/Virginia/ATCC6/2012
Adenoid 75
C243
NY/03/09
C243
NY/03/09
A2
B/FL/04/06
A2
B/FL/04/06
Adenoid 75
1059
Adenoid 75
1059
A2
1059
A2
1059
9320
n/a
9320
n/a
n/a
1059
n/a
1059
Peru6-2003
C-35
Peru6-2003
C-35
n/a
A2
n/a
A2
9320
n/a
9320
n/a
DiagCORE Respiratory Panel 2 Instructions for Use
Respiratory Panel 2 analytes
®
®
Respiratory
Respiratory
®
Concentration
50xLoD
5xLoD
5xLoD
50xLoD
50xLoD
5xLoD
5xLoD
50xLoD
50xLoD
5xLoD
5xLoD
50xLoD
50xLoD
5xLoD
5xLoD
50xLoD
50xLoD
5xLoD
5xLoD
50xLoD
50xLoD
5xLoD
5xLoD
50xLoD
50xLoD
5xLoD
5xLoD
50xLoD
50xLoD
5xLoD
5xLoD
50xLoD
50xLoD
5xLoD
5xLoD
50xLoD
50xLoD
5xLoD
5xLoD
50xLoD
57

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