Product Manual

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Sofia SARS Antigen FIA Page 18 of 22
4. LoD Comparison between Sofia and Sofia 2 Instruments
To compare the LoD between the Sofia and Sofia 2 a study was performed using concurrent
testing of 1x and 2x LoD concentrations (1.13 x10
2
and 2.26 x10
2
, respectively) of heat-
inactivated SARS-CoV-2.
The two instruments generated matching LoDs of TCID
50
2.26 x10
2
in this study.
b) Cross-Reactivity:
Cross-reactivity and potential interference of the Sofia SARS Antigen FIA was evaluated by testing
various microorganisms (8), viruses (16) and negative matrixes (3) with the Sofia SARS Antigen FIA.
Each organism and virus were tested in triplicate in the absence or presence of TCID
50
2.26 x10
2
per mL
of heat inactivated SARS-CoV-2. The final concentration of the organisms and viruses are documented
in the Table below.
Cross-Reactivity: Sofia SARS Antigen FIA – Wet testing
Virus/Bacteria/Parasite*
Strain
Source/
Sample type
Concentration
Cross-Reactive
Results**
Interference
Results**
Adenovirus
Type 1
Isolate
1 x 10
5.53
U/mL
Negative
Positive
Coronavirus
229e
Isolate
1 x 10
5.10
U/mL
Negative
Positive
Coronavirus
OC43
Isolate
9.55 x 10
5
TCID
50
/mL
Negative
Positive
Coronavirus
NL63
Isolate
5 x 10
3.67
U/mL
Negative
Positive
MERS-CoV (heat-
inactivated)
Florida/USA-
2_Saudia
Arabia_2014
Isolate
1.17 x 10
5
TCID
50
/mL
Negative
Positive
Mycoplasma pneumoniae
M129
Isolate
3 x 10
6
CCU/mL
Negative
Positive
Streptococcus pyogenes
Z018
Isolate
3.8 x 10
6
cfu/mL
Negative
Positive
Influenza A H3N2
Brisbane/10/07
Isolate
1 x 10
5.07
U/mL
Negative
Positive
Influenza A H1N1
New
Caledonia/20/99
Isolate
1 x 10
5.66
U/mL
Negative
Positive
Influenza B
Brisbane/33/08
Isolate
1 x 10
5.15
U/mL
Negative
Positive
Parainfluenza
Type 1
Isolate
1 x 10
5.01
U/mL
Negative
Positive
Parainfluenza
Type 2
Isolate
1 x 10
5.34
U/mL
Negative
Positive
Parainfluenza
Type 3
Isolate
8.5 x 10
5
TCID
50
/mL
Negative
Positive
Parainfluenza
Type 4b
Isolate
1 x 10
5.53
U/mL
Negative
Positive
Enterovirus
Type 68
Isolate
1 x 10
5.5
U/mL
Negative
Positive
Human
Metapneumovirus
A1 (IA10-s003)
Isolate
1 x 10
5.55
U/mL
Negative
Positive
Respiratory Syncytial
Virus
Type A (3/2015
Isolate #3)
Isolate
1 x 10
5.62
U/mL
Negative
Positive
Human Rhinovirus
N/A
Inactivated
virus
Not available
Negative
Positive
Chlamydophila
pneumoniae
AR-39
Isolate
2.9 x 10
6
IFU/mL
Negative
Positive
Haemophilus influenzae
Type b; Eagan
Isolate
7.87 x 10
6
cfu/mL
Negative
Positive
Legionella pneumophila
Philadelphia
Isolate
6.82 x 10
6
cfu/mL
Negative
Positive