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12
Performance characteristics.
Analytical Performance
12.1 Sensitivity (Limit of Detection)
The Analytical Sensitivity or Limit of Detection (LoD) is defined as the lowest concentration at which
≥ 95% samples tested generate a positive call.
The LoD of the DiagCORE
representing individual pathogens possible to detect with the DiagCORE
Simulated NPS sample matrix (cultured human cells in Copan UTM) was spiked with one or more
pathogens and tested in 20 replicates.
Individual LoD values for each DiagCORE
Table 1. LoD values obtained for the different respiratory target strains tested in the DiagCORE
Respiratory panel 2.
Pathogen
Influenza A H1N1
Influenza A H3N2
Influenza A, subtype
H1N1/2009
Influenza B
Coronavirus 229E
Coronavirus OC43
Coronavirus NL63
Coronavirus HKU1
Parainfluenza Virus
1
Parainfluenza Virus
2
Parainfluenza Virus
3
Parainfluenza Virus
4a
Respiratory
Syncytial Virus A
Respiratory Panel 2 was determined per analyte using selected strains
®
Respiratory panel 2 target is shown in the table below.
®
Strain
A/New Jersey/8/76
A/Brisbane/59/07
A/New
Caledonia/20/99
A/Virginia/ATCC6/2012
A/Wisconsin/67/2005
A/Port Chalmers/1/73
A/Virginia/ATCC1/2009
A/SwineNY/03/2009
B/Virginia/ATCC5/2012
B/FL/04/06
B/Taiwan/2/62
-
-
-
-
C35
Greer
C 243
M-25
A2
Source
Concentration
ATCC VR-897
28.1 CEID
Zeptometrix
0.04 TCID
0810244CFHI
Zeptometrix
4,6 TCID
0810036CFHI
ATCC VR-1811
0.4 PFU/mL
Zeptometrix
2.5 TCID
0810252CFHI
ATCC VR-810
791.1 CEID
ATCC VR-1736
2.6 PFU/mL
Zeptometrix
14.1 TCID
0810249CFHI
ATCC VR-1807
0.08 PFU/mL
ATCC VR-1804
34.8 CEID
ATCC VR-295
28.1 CEID
ATCC VR-740
0.3 TCID
ATCC-1558
0.1 TCID
Zeptometrix
0.01 TCID
0810228CFHI
Zeptometrix
1/300
1
NATRVP-IDI
ATCC VR-94
23.4 TCID
ATCC VR-92
5.0 TCID
ATCC VR-93
15.8 TCID
ATCC VR-1378
2.8 TCID
ATCC VR-1540
2.8 TCID
DiagCORE Respiratory Panel 2 Instructions for Use
Respiratory Panel 2.
®
®
Detection
rate
/mL
20/20
50
/mL
19/20
50
/mL
19/20
50
19/20
/mL
20/20
50
/mL
20/20
50
20/20
/mL
20/20
50
20/20
/mL
19/20
50
/mL
20/20
50
/mL
20/20
50
/mL
20/20
50
/mL
20/20
50
19/20
/mL
20/20
50
/mL
19/20
50
/mL
20/20
50
/mL
20/20
50
/mL
20/20
50
51
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