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Table 1 – Limit of Detection
SARS-CoV-2*
Influenza A H1N1 pdm**
Influenza A H3N2 (Singapore/
INFIMH-16-0019/16)**
Influenza B Wisconsin/1/10**
RSV A virus**
RSV B virus**
* determined using a spiking approach in artificial simulated matrix (Respiratory Swab
Matrix, Vircell) in eNAT® (COPAN) plus 1000 hPBTEC (human primary bronchial/tra-
cheal epithelial cells).
** determined using Zeptometrix material for a spiking approach in Lolly-saliva samples
in eNAT® (COPAN).
Table 2 – Inclusivity
SARS-CoV-2 B.1.1.7
(Vircell AMPLIRUN® RNA Control)*
SARS-CoV-2 B.1.351
(Vircell AMPLIRUN® RNA Control)*
SARS-CoV-2 P.1
(Vircell AMPLIRUN® RNA Control)*
SARS-CoV-2 B.1.617.2
(Vircell AMPLIRUN® RNA Control)*
SARS-CoV-2
(Vircell AMPLIRUN® Total Control)*
SARS-CoV-2 B.1.1.7 + Q.x**
SARS-CoV-2 B.1.351 + SARS-CoV-2
B.1.351.2 + B.1.351.3**
SARS-CoV-2 B.1.429 + B.1.427**
SARS-CoV-2 B.1.525**
SARS-CoV-2 B.1.526**
SARS-CoV-2 B.1.617.1**
SARS-CoV-2 B.1.617.2 + AY.x**
SARS-CoV-2 B.1.617.3**
SARS-CoV-2 B.1.621 + B.1.621.1**
SARS-CoV-2 C.37 + C.37.1**
SARS-CoV-2 P.1 + P.1.x**
SARS-CoV-2 P.2**
Vivalytic SARS-CoV-2 DT, Flu A/B, RSV
117 virus particles/test
1,17x10
5,01 x10
1,7 TCID
12,6 TCID
4,68 x 10
Influenza B/Massechusetts/2/2012
(Yamagata-Line)
(50 TCID
Influenza B/Yamagata/16/88
(5 TCID
RSV A (Isolate:2006 Isolate) (25
TCID
RSV B (Strain: CH93(18) -18)
(0,25 TCID
Influenza A A/Brisbane/59/2007
(H1N1)**
Influenza A A/Texas/50/2012
(H3N2)
Influenza A A/Victoria/361/2011
(H3N2)**
Influenza A A/Perth/16/2009
Influenza A A/Brisbane/10/2007
(H3N2)**
Influenza A A/Kansas/14/2017
(H3N2)**
Influenza A A/Michigan/45/2015
(H1N1)**
Influenza A A/Singapore/
INFIMH-16- 0019/2016
Influenza A A/Cambodia/
e0826360/2020 (H3N2)**
Influenza A A/Wisconsin/588/2019
(H1N1)**
Influenza A A/Hawaii/70/2019
(H1N1)**
Influenza B B/Massachusetts/2/2012
(Yamagata-Line)**
Influenza B B/Wisconsin/1/2010
(Yamagta-Line)**
144
TCID
/ml
-1
50
TCID
/ml
2
50
/ml
50
/ml
50
TCID
/ml
-1
50
/ml, Zeptometrix***)
50
/ml, Zeptometrix***)
50
/ml, Zeptometrix***)
50
/ml, Zeptometrix***)
50
– Annex
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