days. ENGLISH - 14 - 1 3 4 2 Allow all kit components to reach a temperature between 15- 30°C prior to testing for 30 minutes. Note: Healthcare professionals should comply with personal safety guidelines including the use of personal protective equipment. Carefully read these instructions prior to using Panbio™ COVID-19 Ag Rapid Test Device kit. Look at the expiration date of the kit box. If the expiration date has passed, use another kit. Open the package and look for the following: 1. Test device with desiccant in individual foil pouch 2. Buffer 3. Extraction tube 4. Extraction tube cap 5. Positive control swab 6. Negative control swab 7. Sterilized nasal swabs for sample collection 8. Tube rack 9. Quick reference guide 10. Instructions for use PREPARATION 5 Open the foil pouch and look for the following: 1. Result window 2. Specimen well Then, label the device with the patient identifier. : 5 drops of the extracted specimen 1 2 ENGLISH - 15 - Hold the buffer bottle vertically and fill the extraction tube with buffer fluid until it flows up to the Fill-line of the extraction tube (300μl). Caution: If the amount of buffer is excessive or insufficient, an improper test result may occur. Place the extraction tube in the tube rack. Tilt the patient’s head back 70 degrees. While gently rotating the swab, insert swab less than one inch (about 2 cm) into nostril (until resistance is met at the turbinates). Rotate the swab five times against the nasal wall. Using the same swab repeat the collection procedure with the second nostril. Slowly remove swab from the nostril. Caution: If the swab stick breaks during specimen collection, repeat specimen collection with a new swab. 1 2 3 TEST PROCEDURE 70˚ x5 x5 300μl ENGLISH - 16 - Break the swab at the breakpoint and close the cap of extraction tube. Open the dropping nozzle cap at the bottom of the extraction tube. TEST PROCEDURE 5 6 Insert the swab specimen in the extraction tube. Swirl the swab tip in the buffer fluid inside the extraction tube, pushing into the wall of the extraction tube at least five times and then squeeze out the swab by squeezing the extraction tube with your fingers. 4 x 5 Dispense 5 drops of extracted specimens vertically into the specimen well (S) on the device. Do not handle or move the test device until the test is complete and ready for reading. Caution: Bubbles that occur in the extraction tube can lead to inaccurate results. If you are unable to create sufficient drops, this may be caused by clogging in the dispensing nozzle. Shake the tube gently to release the blockage until you observe free drop formation. 7 5 x ENGLISH - 17 - Close the nozzle and dispose of the extraction tube containing the used swab according to your local regulations and biohazard waste disposal protocol. TEST PROCEDURE 8 Start timer. Read result at 15 minutes. Do not read results after 20 minutes. Dispose of the used device according to your local regulations and biohazard waste disposal protocol. 9 10 15-20 MIN ENGLISH - 18 - TEST INTERPRETATION The presence of the test line (T) and the control line (C) within the result window, regardless of which line appears first, indicates a positive result. Caution: The presence of any test line (T), no matter how faint, indicates a positive result. If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Instructions may not have been followed correctly. It is recommended to read the IFU again before re-testing the specimen with a new test device. POSITIVE INVALID The presence of only the control line (C) and no test line (T) within the result window indicates a negative result. NEGATIVE - 19 - REFERENCES 1. Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020; Feb 26:102433. doi: 10.1016/j.jaut.2020.102433. 2. Guo YR, Cao QD, Hong ZS, et al. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak-an update on the status. Mil Med Res. 2020; Mar 13; 7(1):11.doi:10.1186/s40779-020-00240-0. 3. Lai CC, Shih TP, Ko WC, et al. Severe acute respiratory syndrome coronavirus 2 (SARSCov-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020; Mar 55(3): 105924.doi: 10.1016/j.ijantimicag.2020.105924. 4. In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends (Sandeep Kumar Vashist, 2020 April 05: diagnostics) 5. Nano Research for COVID-19 (http://dx.doi.org/10.1021/acsnano.0c02540) 6. Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients (Stephen M, Hahn M.D. 2020 May 09: Commisioner of Food and Drugs 7. Current Intelligence Bulletin 13: Explosive Azide Hazard DHHS (NIOSH) Publication Number 78-127 August 16, 1976 8. CDC. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Hea Home Test Extracting Reagent ingredients, volume (if available) Product warnings Storage container BinaxNOW (Abbott) Sodium azide 0.025%, 1mL Nonspecific Dropper QuickVue (Quidel) Sodium phosphate Dibasic 0.7%, C12-14-alkyldimethylbetaines 0.7%), ProClin™ 300, EDTA 0.03% Eye irritation/damage, burns, allergic reactions Test-tube InteliSwab (OraSure) Triton™ X-100 (detergent), ProClin ™ 950,