Assay Robustness; Exclusivity (Analytical Specificity) - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

Pathogen
Respiratory
Syncytial Virus B
Human
Metapneumovirus
Adenovirus
Bocavirus
Enterovirus
Rhinovirus
Mycoplasma
pneumoniae
Legionella
pneumophila
Bordetella pertussis
Relative dilution from stock concentration.
1

12.2 Assay Robustness

The verification of robust assay performance was assessed by analyzing the Internal Control
performance in clinical nasopharyngeal swab samples. 30 individual nasopharyngeal swab
samples negative for all pathogens possible to detect were analysed with the DiagCORE
Respiratory Panel 2.
All samples tested showed a positive result and valid performance for the Internal Control of the
DiagCORE

12.3 Exclusivity (Analytical Specificity)

Exclusivity study was carried out by in silico analysis and in vitro testing to assess the Analytical
Specificity of the DiagCORE
are not covered by the panel. These organisms included specimens which are related to, but
distinct from, respiratory panel organisms, or that could be present in specimens collected from the
52 DiagCORE Respiratory Panel 2 Instructions for Use
Strain
9320
Peru6-2003 (type B2)
hMPV-16, IA10-2003
GB (Adenovirus B3)
RI-67 (Adenovirus E4)
Adenoid 75 (Adenoviurs
C5)
Adenoid 71 (Adenovirus
C1)
Adenovirus C2
Adenovirus C6
Clinical sample
/US/IL/14-18952
(Enterovirus D68)
Echovirus 6 (D-1 (Cox))
1059 (Rhinovirus B14)
HGP (Rhinovirus A2)
11757 (Rhinovirus A16)
Type 1A
M129-B7
CA1
I028
A639
Respiratory Panel 2.
®
Respiratory Panel 2 for respiratory or non-respiratory organisms which
®
Source Concentration
ATCC VR-955 0.02 TCID
Zeptometrix
1.1 TCID
0810159CFHI
Zeptometrix
3.0 TCID
0810161CFHI
ATCC VR-3 50.0 TCID
ATCC VR-1572 15.8 TCID
ATCC VR-5 5.0 TCID
ATCC VR-1 5.0 TCID
ATCC VR-846 28.1 TCID
ATCC VR-6 505.6 TCID
- >1.0 copies/mL
ATCC VR-1824 50.0 TCID
ATCC VR-241 0.001 TCID
ATCC VR-284 28.1 TCID
ATCC VR-482 0.3 TCID
ATCC VR-283 8.9 TCID
ATCC VR-1559 5.0 TCID
ATCC 29342 0.1 CFU/mL
ATCC 700711 >0.01 CFU/mL
ATCC BAA-
>0.001 CFU/mL
2707
Zeptometrix
1/10000
1
NATRVP-IDI
Detection
rate
/mL 20/20
50
/mL 19/20
50
/mL 20/20
50
/mL 20/20
50
/mL 20/20
50
/mL 20/20
50
/mL 19/20
50
/mL 20/20
50
/mL 20/20
50
20/20
/mL 19/20
50
/mL 19/20
50
/mL 20/20
50
/mL 19/20
50
/mL 20/20
50
/mL 20/20
50
20/20
20/20
20/20
19/20
®