requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don’t preclude SARSCoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a donor screening test for SARS-CoV-2. EN ENGLISH - 2 - Kit Variants • 41FK11 No 2D barcode printed on the contained test devices • 41FK21 Contains test devices with a 2D barcode printed on the test device, which encodes traceability information for the product Materials Provided • 25 Test devices with desiccant in individual foil pouch • Buffer (1 x 9 ml/bottle) • 25 Extraction tubes • 25 Extraction tube caps • 1 Positive control swab • 1 Negative control swab • 25 Sterilized nasal swabs for sample collection • 1 Tube rack • 1 Quick Reference Guide • 1 Instructions for use Materials Required but not Provided • Personal Protective Equipment per local recommendations (i.e. gown/ lab coat, face mask, face shield/eye goggles and gloves), Timer, Biohazard container Active Ingredients of Main Components • 1 Test device Gold conjugate: Human IgG specific to SARS-CoV-2 Ag gold colloid and Chicken IgY - gold colloid, Test line: Mouse monoclonal antiSARS-CoV-2, Control line: Mouse monoclonal anti-Chicken IgY • Buffer Tricine, Sodium Chloride, Tween 20, Sodium Azide (30 are no longer contagious. 8, 9, 10 • The clinical performance data was also calculated vs nasopharyngeal swab specimens using an FDA EUA RT-PCR reference and has a sensitivity of 91.1% (95% CI: 84.2-95.6%) and specificity of 99.7% (95% CI: 98.6- 100.0%). 2. External evaluation of Panbio™ COVID-19 Ag Rapid Test Device (Asymptomatic) Clinical performance of Panbio™ COVID-19 Ag Rapid Test Device was determined by testing 483 asymptomatic subjects for SARS-CoV-2 antigen (Ag). Clinical specimens were determined to be positive or negative using an FDA EUA RT-PCR reference method. The positive results (n=50) were stratified by the comparator method cycle threshold (Ct) counts and assessed to better understand the correlation of product performance, as a surrogate for the amount of virus present in the clinical sample. A lower Ct value corresponds to a higher virus concentration. As presented in the table below, the positive agreement increases with lower Ct values. ENGLISH - 8 - The specificity (n=433) was 100% with 95% CI [99.2%; 100.0%]. The results for sensitivity are summarized in the following table: All Nasal PCR Positive Samples (n=50) Ct values ≤ 33 (n=40) Ct values ≤ 30 Ct (n=32) Sensitivity [CI 95%] 66.0% [51.2%; 78.8%] 80.0% [64.4%; 90.9%] 93.8% [79.2%; 99.2%] As indicated in References 8-10, patients with Ct value >30 are no longer contagious. 8, 9, 10 3. External evaluation of Panbio™ COVID-19 Ag Rapid Test Device (SelfCollected Swab) The clinical performance of Panbio™ COVID-19 Ag Rapid Test Device was assessed in 287 symptomatic subjects (≥16 years of age) who collected their swab specimen (self swabbing) under the direction and supervision of a trained professional. The swab was then handed to the trained professional who executed the remaining steps of the procedure. The trained professional also collected a nasopharyngeal swab from each subject to be used as a reference specimen. The reference specimen was tested on the Panbio™ COVID-19 Ag Rapid Test Device. The results are summarized in the following table: Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal) Positive Negative Total Panbio™ COVID-19 Ag Rapid Test Device (Nasal) – Self-collected Swab Positive 110 0 110 Negative 2 175 177 Total 112 175 287 Positive Agreement Negative Agreement Overall Percent Agreement 98.2% [93.7%; 99.8%] 100.0% [97.9%; 100.0%] 99.3% [97.5%; 99.9%] 4. Detection Limit Panbio™ COVID-19 Ag Rapid Test Device was confirmed to detect 2.5X101.8 TCID50/ml of SARS-CoV-2 which was isolated from a COVID-19 confirmed patient in Korea. 5. Hook Effect There is no hook effect at 1.0x105.8 TCID50/ml of SARS-CoV-2 which was isolated from a COVID-19 confirmed patient in Korea. 6. Cross Reactivity Cross-reactivity of Panbio™ COVID-19 Ag Rapid Test Device was evaluated by testing 28 viruses and 13 other microorganisms. The final test concentrations of viruses and other microorganisms are documented in the ENGLISH - 9 - Table below. The following viruses and other microorganisms except the Human SARS-coronavirus Nucleoprotein have no effect on the test results of Panbio™ COVID-19 Ag Rapid Test Device. Panbio™ COVID-19 Ag Rapid Test Device has cross-reactivity with HumanSARS-coronavirus Nucleoprotein at a concentration of 25 ng/ml or more because SARS-CoV has high homology (79.6%) to the SARS-CoV-2. No. Types of Specimen Cross Reaction Substance Final Test Concentration Test Result 1 Virus Adenovirus Type 1 2.2 X 107 TCID50/ml No cross reaction 2 Adenovirus Type 5 5.71 X 108 TCID50/ml No cross reaction 3 Adenovirus Type 7 2.86 X 109 TCID50/ml No cross reaction 4 Enterovirus (EV68) 2.81 X 107 TCID50/ml No cross reaction 5 Echovirus2 1.0 X 106.5 TCID50/ml No cross reaction 6 Echovirus11 5.0 X106.25 TCID50/ml No cross reaction 7 Enterovirus D68 2.81 X 107 TCID50/ml No cross reaction 8