Human herpesvirus (HSV) 1 5.0 X 107.5 TCID50/ml No cross reaction 9 Human herpesvirus (HSV) 2 5.0 X 105.75 TCID50/ml No cross reaction 10 Mumps Virus Ag 1.58 X 105 TCID50/ml No cross reaction 11 Influenza virus A (H1N1) Strain (A/Virginia/ATCC1/2009) 3.71 X 105 PFU/ml No cross reaction 12 Influenza virus A (H1N1) Strain (A/WS/33) 5.0 X 107.25 TCID50/ml No cross reaction 13 Influenza virus A(H1N1) Strain (A/California/08/2009/pdm09) 1.6 X 108 TCID50/ml No cross reaction 14 Influenza virus B Strain (B/ Lee/40) 5.0 X 106.25 TCID50/ml No cross reaction 15 Parainfluenza Type 1 3.06 X 108 TCID50/ml No cross reaction 16 Parainfluenza Type 2 5.0 X 105 TCID50/ml No cross reaction ENGLISH - 10 - No. Types of Specimen Cross Reaction Substance Final Test Concentration Test Result 17 Virus Parainfluenza Type 3 6.6 X 107 TCID50/ml No cross reaction 18 Parainfluenza Type 4A 2.81 X 107 TCID50/ml No cross reaction 19 Respiratory syncytial virus (RSV) type A 4.22 X 105 TCID50/ml No cross reaction 20 Respiratory syncytial virus (RSV) type B 5.62 X 105 TCID50/ml No cross reaction 21 Rhinovirus A16 1.26 X 106 TCID50/ml No cross reaction 22 HCoV-HKU1 1.5mg/ml No cross reaction 23 HCoV-NL63 1.7 X 105 TCID50/ml No cross reaction 24 HCoV-OC43 8.9 X 105 TCID50/ml No cross reaction 25 HCoV-229E 1.51 X 106 TCID50/ml No cross reaction 26 Human SARS-coronavirus Nucleoprotein 25ng/ml Cross reaction 27 MERS-CoV Nucleoprotein 0.25mg/ml No cross reaction 28 Human Metapneumovirus (hMPV) 16 Type A1 1.51 X 106 TCID50/ml No cross reaction ENGLISH - 11 - No. Types of Specimen Cross Reaction Substance Final Test Concentration Test Result 1 Other Microorganism Staphylococcus saprophyticus 1.9 X 107 CFU/ ml No cross reaction 2 Neisseria sp.(Neisseria lactamica) 1.7 X 108 CFU/ ml No cross reaction 3 Staphylococcus haemolyticus 3.5 X 109 CFU/ ml No cross reaction 4 Streptococcus salivarius 1.96 X 107 CFU/ ml No cross reaction 5 Hemophilus parahaemolyticus 2.2 X 108 CFU/ ml No cross reaction 6 Proteus vulgaris 7.2 X 106 CFU/ ml No cross reaction 7 Moraxella catarrhalis 4.7 X 107 CFU/ ml No cross reaction 8 Klebsiella pneumoniae 5.0 X 106 CFU/ ml No cross reaction 9 Fusobacterium necrophorum 1.75 X 108 CFU/ ml No cross reaction 10 Mycobacterum tuberculosis 10mg/ml No cross reaction 11 Pooled human nasal wash N/A* No cross reaction 12 Streptococcus pyogenes 3.6 X 107 CFU/ ml No cross reaction 13 Mycoplasma pneumoniae 4 X 108 CFU/ml No cross reaction * No concentration provided by supplier. Undiluted stock solution was tested. 7. Interfering Substances The following 43 potentially interfering substances have no impact on Panbio™ COVID-19 Ag Rapid Test Device. The final test concentrations of the interfering substances are documented in the Table below. ENGLISH - 12 - No. Types of Specimen Interfering Substances Final Test Concentration Test Result 1 Endogenous Substance Mucin 0.5% No Interference 2 Hemoglobin 100 mg/L No Interference 3 Triglycerides 1.5 mg/L No Interference 4 Icteric (Bilirubin) 40 mg/dL No Interference 5 Rheumatoid factor 200 IU/ml No Interference 6 Anti-nuclear antibody >1:40 No Interference 7 Pregnant 10-fold dilution No Interference 8 Exogenous Substance Guaiacol glyceryl ether 1 μg/ml No Interference 9 Albuterol 0.005 mg/dL No Interference 10 Ephedrine 0.1 mg/ml No Interference 11 Chlorpheniramine 0.08 mg/dL No Interference 12 Diphenhydramine 0.08 mg/dL No Interference 13 Ribavirin 26.7 μg /ml No Interference 14 Oseltamivir 0.04 mg/dL No Interference 15 Zanamivir 17.3 μg /ml No Interference 16 Phenylephrine hydrochloride 15% v/v No Interference 17 Oxymetazolin hydrochloride 15% v/v No Interference 18 Amoxicillin 5.4 mg/dL No Interference 19 Acetylsalicylic acid 3 mg/dL No Interference 20 Ibuprofen 21.9 mg/dL No Interference 21 Chlorothiazide 2.7 mg/dL No Interference 22 Indapamide 140 ng/ml No Interference 23 Glimepiride (Sulfonylureas) 0.164 mg/dL No Interference 24 Acarbose 0.03 mg/dL No Interference 25 Ivermectin 4.4 mg/L No Interference 26 Lopinavir 16.4 μg/L No Interference 27 Ritonavir 16.4 μg/L No Interference 28 Chloroquine phosphate 0.99 mg/L No Interference ENGLISH - 13 - No. Types of Specimen Interfering Substances Final Test Concentration Test Result 29 Exogenous Substance Sodium chloride with preservatives 4.44 mg/ml No Interference 30 Beclomethasone 4.79 ng/ml No Interference 31 Dexamethasone 0.6 µg/ml No Interference 32 Flunisolide 0.61 µg/ml No Interference 33 Triamcinolone 1.18 ng/ml No Interference 34 Budesonide 2.76 ng/ml No Interference 35 Mometasone 1.28 ng/ml No Interference 36 Fluticasone 2.31 ng/ml No Interference 37 Sulfur 9.23 µg/ml No Interference 38 Benzocaine 0.13 mg/ml No Interference 39 Menthol 0.15 mg/ml No Interference 40 Mupirocin 10 µg/ml No Interference 41 Tobramycin 24.03 µg/ml No Interference 42 Biotin 1.2 µg/ml No Interference 43 HAMA 63.0 ng/ml No Interference 8. Repeatability & Reproducibility Repeatability & Reproducibility of Panbio™ COVID-19 Ag Rapid Test Device was established using in-house reference panels containing negative specimens and a range of positive specimens. There were no differences observed within-run, between-run, between-lots, between-sites, and between-