Product Manual

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Sofia SARS Antigen FIA Page 19 of 22
Cross-Reactivity: Sofia SARS Antigen FIA – Wet testing
Virus/Bacteria/Parasite*
Strain
Source/
Sample type
Concentration
Cross-Reactive
Results**
Interference
Results**
Streptococcus
pneumoniae
Z022; 19f
Isolate
2.26 x 10
6
cfu/mL
Negative
Positive
Bordetella pertussis
A639
Isolate
6.37 x 10
6
cfu/mL
Negative
Positive
Pneumocystis jirovecii-S.
cerevisiae Recombinant
W303-Pji
Isolate
1.56 x 10
6
cfu/mL
Negative
Positive
*Coronavirus HKU1 was not tested for cross-reactivity due to lack of availability. Given that the 19 specimens
in the clinical evaluation that were positive for this strain all resulted as negative, cross-reactivity wet testing
was not required.
** Testing was performed in triplicate.
Based on the data generated by this study, the organisms or viruses tested Sofia SARS Antigen FIA do not
cross-react or interfere.
c) Hook Effect:
As part of the LoD study the highest concentration of heat-inactivated SARS-CoV-2 stock available
(TCID
50
of 3.40 x10
5
per mL) was tested. There was no Hook effect detected.
d) Endogenous Interference Substances Studies:
A study was performed demonstrate that fourteen (14) potentially interfering substances that may be
found in the upper respiratory tract do not cross-react or interfere with the detection of SARS-CoV-2 in
the Sofia SARS Antigen FIA Assay.
Interfering Substance
Active Ingredient
Concentration
Cross-Reactive
Results*
Interference
Results*
Afrin – nasal spray
Oxymetazoline
5%
Negative
Positive
Blood (human)
Blood
5%
Negative
Positive
Chloraseptic, Cepacol
Benzocaine, Menthol
0.7 g/mL
Negative
Positive
Flonase
Fluticasone
5%
Negative
Positive
Halls Relief Cherry Flavor
Menthol
0.8 g/mL
Negative
Positive
Nasocort Allergy 24 hour
Triamcinolone
5.00%
Negative
Positive
Neo-Synephrine
Phenylephrine
hydrochloride
5%
Negative
Positive
Oseltamivir
Oseltamivir
2.2 µg/mL
Negative
Positive
Purified mucin protein
Mucin protein
2.5 mg/mL
Negative
Positive
Rhinocort
Budesonide
(Glucocorticoid)
5%
Negative
Positive
Saline nasal spray
Saline
15%
Negative
Positive
Tobramycin
Tobramycin
1.25 mg/mL
Negative
Positive
Zanamivir
Zanamivir
282.0 ng/mL
Negative
Positive
Zicam Cold Remedy
Galphimia glauca, Luffa
operculata, Sabadilla
5%
Negative
Positive
* Testing was performed in triplicate.
Based on the data generated by this study, the substances tested Sofia SARS Antigen FIA do not cross-react
or interfere.