Inclusivity (Analytical Reactivity) - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

All pathogens tested showed a negative result, no cross-reactivity was observed for the organisms
tested in the DiagCORE
In silico analysis was performed for all primer/probe designs included in the DiagCORE
Panel 2 proving specific amplification and detection of targets without cross-reactivity.

12.4 Inclusivity (Analytical Reactivity)

An inclusivity study was performed to analyse the detection of a variety of strains that represent
the genetic diversity of each respiratory panel target organism ("inclusivity strains"). Inclusivity
strains for all analytes were included in the study, representative of the species/types for the
different organisms, e.g. a range of Influenza A strains isolated from different geogracphical areas
and in different calendar years were included. Next table below shows the list of respiratory
pathogens tested in this study.
Table 1. List of Analytical Reactivity pathogens tested.
Pathogen
Influenza A
Influenza B
Coronavirus 229E
54 DiagCORE Respiratory Panel 2 Instructions for Use
Type
Aspergillus fumigatus
Fungi Candida albicans
Cryptococcus neoformans
Respiratory Panel 2 (except for Bordetella holmesii as described above).
®
Subtype/
Serotype
A/PR/8/34
A/New Jersey/8/76
H1N1
A/Brisbane/59/07
A/New Caledonia/20/99
A/Virginia/ATCC6/2012
A/Wisconsin/67/2005
A/Port Chalmers/1/73
H3N2
A/Victoria/3/75
A/Brisbane/10/07
A/Virginia/ATCC2/2009
A/Virginia/ATCC3/2009
H1N1
A/Virginia/ATCC1/2009
(pan)
A/SwineNY/03/2009
H1N1/NY/02/09
B/Virginia/ATCC5/2012
B/FL/04/06
B/Taiwan/2/62
n/a
B/Panama/45/90
B/Florida/02/06
B/Maryland/1/59
n/a
n/a
n/a
Pathogen
Strain
ATCC VR-1469
ATCC VR-897
Zeptometrix 0810244CFHI
Zeptometrix 0810036CFHI
ATCC VR-1811
Zeptometrix 0810252CFHI
ATCC VR-810
ATCC VR-822
Zeptometrix NATRVP-IDI
ATCC VR-1737
ATCC VR-1738
ATCC VR-1736
Zeptometrix 0810249CFHI
Zeptometrix NATRVP-IDI
ATCC VR-1807
ATCC VR-1804
ATCC VR-295
Zeptometrix NATFLUB-ERCM
Zeptometrix 810037CFHI
ATCC VR-296
ATCC VR-740
Zeptometrix NATRVP-IDI
Respiratory
®
Source