STAT-Dx DiagCORE Respiratory Panel 2, Instructions For Use Manual, Page: 51 / 67

DiagCORE Respiratory Panel 2 Instructions for Use 51
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
®
Respiratory Panel 2 was determined per analyte using selected strains
representing individual pathogens possible to detect with the DiagCORE
®
Respiratory Panel 2.
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
®
Respiratory panel 2 target is shown in the table below.
Table 1. LoD values obtained for the different respiratory target strains tested in the DiagCORE ®
Respiratory panel 2.
Pathogen Strain Source Concentration Detection
rate
Influenza A H1N1
A/New Jersey/8/76 ATCC VR-897 28.1 CEID
50
/mL 20/20
A/Brisbane/59/07
Zeptometrix
0810244CFHI
0.04 TCID
50
/mL 19/20
A/New
Caledonia/20/99 Zeptometrix
0810036CFHI
4,6 TCID
50
/mL 19/20
Influenza A H3N2
A/Virginia/ATCC6/2012 ATCC VR-1811 0.4 PFU/mL 19/20
A/Wisconsin/67/2005 Zeptometrix
0810252CFHI
2.5 TCID
50
/mL 20/20
A/Port Chalmers/1/73 ATCC VR-810 791.1 CEID
50
/mL 20/20
Influenza A, subtype
H1N1/2009
A/Virginia/ATCC1/2009 ATCC VR-1736 2.6 PFU/mL 20/20
A/SwineNY/03/2009
Zeptometrix
0810249CFHI
14.1 TCID
50
/mL 20/20
Influenza B
B/Virginia/ATCC5/2012 ATCC VR-1807 0.08 PFU/mL 20/20
B/FL/04/06 ATCC VR-1804 34.8 CEID
50
/mL 19/20
B/Taiwan/2/62 ATCC VR-295 28.1 CEID
50
/mL 20/20
Coronavirus 229E - ATCC VR-740 0.3 TCID
50
/mL 20/20
Coronavirus OC43 - ATCC-1558 0.1 TCID
50
/mL 20/20
Coronavirus NL63 -
Zeptometrix
0810228CFHI
0.01 TCID
50
/mL 20/20
Coronavirus HKU1 -
Zeptometrix
NATRVP-IDI
1/300 1 19/20
Parainfluenza Virus
1
C35 ATCC VR-94 23.4 TCID
50
/mL 20/20
Parainfluenza Virus
2
Greer ATCC VR-92 5.0 TCID
50
/mL 19/20
Parainfluenza Virus
3
C 243 ATCC VR-93 15.8 TCID
50
/mL 20/20
Parainfluenza Virus
4a
M-25 ATCC VR-1378 2.8 TCID
50
/mL 20/20
Respiratory
Syncytial Virus A
A2 ATCC VR-1540 2.8 TCID
50
/mL 20/20