INSTRUCTION COVID-19 RAPID GUIDE ANTIGEN TEST …

1 INSTRUCTION COVID-19 RAPID . GUIDE ANTIGEN TEST Ref # IN-COVAG-001SG01A. F REQU E NT LY A S KED Q U E STI O N S (FAQ s ). INTENDED USE PRINCIPLE. I ACCIDENTALLY SPILLED THE TEST SOLUTION. IS IT HARMFUL? INDICAID COVID-19 RAPID ANTIGEN Test is an in vitro diagnostic During COVID-19 infection, the virus SARS-CoV-2 is found in the test for determining the presence of SARS-CoV-2 ANTIGEN in upper respiratory tract. SARS-CoV-2 antigens are substances of If the test solution has been spilled, ush abundantly with water upon disposal. direct nasal swab samples or nasopharyngeal swab sample. the virus that serve as markers for disease exposure. This test is intended for self-testing and/or professional use. Avoid having the test solution come into contact with your eyes, skin and mouth.

2 If contact occurs with the eyes, ush with water immediately and seek medical help. If contact occurs with your skin, wash the area with soap and rinse with water. CONTAINED IN THIS BOX Do not ingest or inhale the test solution. If accidental ingestion occurs, please seek medical help immediately. 1 individually-wrapped 1 vial of buffer solution 1 individually-wrapped swab 1 INSTRUCTION GUIDE test device HOW DEEP SHOULD I INSERT THE SWAB INTO MY NOSTRILS? Inserting the swab into the nostril should be deep enough to collect samples for this test. Once you feel a slight resistance, proceed to gently collect your sample. Check the swab after collection to ensure the tip is covered in nasal secretion. HOW TO USE. WHAT DO I DO WITH THE TEST KIT AFTER READING THE RESULTS?

3 Remove the test device and Tilt your head back. Gently insert the swab The buffer solution vial cap is Close the entire vial cap composed of two parts. Remove the After completing the test and recording your results, carefully wrap all product components and dispose them into the swab from their packaging. about into one of your nostrils. Rub tightly. Immediately entire cap. Stir the swab into the buffer garbage just like any other household trash. Wash your hands thoroughly with soap and water after handling the 01. the swab against the wall of one of your perform Steps 5-7. components. 04. nostrils at least 5 times in a large circular solution by twisting the swab back and path. Repeat with your forth 20 times. Slightly tilt the vial to other nostril.

4 Ensure the swab tip HOW ACCURATE IS THE TEST? 02. is fully submerged in the solution. In a study using prospective nasal and retrospective nasopharyngeal swab specimens, the INDICAID COVID-19 RAPID ANTIGEN Test has been clinically validated to achieve a high detection accuracy , reaching a relative detection speci city of 03. x5. x 20 >95% and relative detection sensitivity of 91% respectively (Table A). Table A (Study with prospective nasal and retrospective nasopharyngeal swab specimens). Remove the top half of the Hold the vial vertically. Squeeze and Leave for 20 minutes and read the *Watch the how-to-use video vial cap to expose the dropper drip 3 drops of the solution into the results. Do not read after 25 minutes. by scanning the QR code. tip.

5 Circular opening Refer to the Interpreting Your Comparator Method (RT-qPCR). INDICAID COVID-19 . of the test device. Results section below. 05. RAPID ANTIGEN Test Positive Negative Total 06 07 20. Positive 91 12 103. mins Negative 9 278 287. Total 100 290 390. Positive Percentage Agreement (PPA) 91% (95% Cl: - ). Negative Percentage Agreement (NPA) 96% (95% Cl: - ). INTERPRETING YOUR RESULTS : INDICATOR RESULTS INTERPRETATION. A line appears in regions Positive This result indicates the presence of SARS-CoV-2 ANTIGEN C. (C) and (T) in the sample. T. A line appears in the Negative This results indicates no SARS-CoV-2 ANTIGEN is detected in C region (C) the sample. Regular testing (at least once every week) is T. recommended. If you have been in contact with a known or suspected COVID-19 case, we recommend that you arrange a PCR test to con rm your negative result.

6 No line appears in the Invalid There was an issue with the specimen collection or the test C. region (C) processing. Repeat the test with a new test kit. T. IMPORTANT LIMITATIONS. For in vitro diagnostic use The test is designed for using direct nasal swab sample or User should not make any decision of medical relevance without rst nasopharyngeal swab sample. consulting their health care provider Negative results do not rule out COVID-19 infection, especially if you All components in this test kit should remain sealed until ready for use have been in contact with the virus. A follow-up PCR test should be The test must be performed between 15-30 C considered to rule out infection All components in this test kit are for one-time use only. Do not reuse Positive results may be due to current infection with Store at 2-30 C.

7 Do not freeze. Avoid direct sunlight non-SARS-CoV-2 coronavirus strains Do not swallow or inhale Results from ANTIGEN testing should not be used as the sole basis to diagnose or exclude COVID-19 infection Avoid contact with your eyes. If contact occurs, ush with water immediately and seek medical help The presence of Fluticasone Propionate (Flonase) in the nasal swab Do not use the test kit after the expiration date specimen may give inaccurate results Samples with low levels of ANTIGEN may give a faint test line. Any visible pink/purple colored line is positive, do not compare the color intensity of PI-0005 | Rev B | For in vitro diagnostics | Contents are subject to change without MANUFACTURER. each indicator line to another notice | 2021 PHASE Scienti c Int'l Ltd, all rights reserved.

8 PHASE Scienti c International Limited If you have questions about the product, please contact Customer Service 32 & 33/F, Gravity, 29 Hing Yip Street, at Kwun Tong, Kowloon, Hong Kong . Ref # IN-COVAG-001SG01A .. INDICAID SARS-CoV-2 . (SARS-CoV-2) SARS-CoV-2 . / .. 1 1 1 1 .. 5-7 .. 5 . 20 . 01 04 INDICAID . 02 96% 91% A .. A ( ). x5. 03 x 20. RT-qPCR . INDICAID .. 20 25 * . 3 91 12 103.. 9 278 287. 05 100 290 390. 06 07 20. 91% (95% Cl: - ). 96% (95% Cl: - ).. C T SARS-CoV-2 .. C. T. (C) SARS-CoV-2 . ( ) . C. T . (C) . C.. T.. 15-30 C SARS-CoV-2 .. 2-30 C Flonase .. PI-0005 | Rev B | |.. | 2021 PHASE Scienti c Int'l Ltd, . 29 32 33 . INSTRUCTION COVID-19 RAPID . GUIDE ANTIGEN TEST Ref # IN-COVAG-025SG01A. F REQU E NT LY A S KED Q U E STI O N S (FAQ s ).

9 INTENDED USE PRINCIPLE. I ACCIDENTALLY SPILLED THE TEST SOLUTION. IS IT HARMFUL? INDICAID COVID-19 RAPID ANTIGEN Test is an in vitro diagnostic During COVID-19 infection, the virus SARS-CoV-2 is found in the test for determining the presence of SARS-CoV-2 ANTIGEN in upper respiratory tract. SARS-CoV-2 antigens are substances of If the test solution has been spilled, ush abundantly with water upon disposal. direct nasal swab samples or nasopharyngeal swab sample. the virus that serve as markers for disease exposure. This test is intended for self-testing and/or professional use. Avoid having the test solution come into contact with your eyes, skin and mouth. If contact occurs with the eyes, ush with water immediately and seek medical help. If contact occurs with your skin, wash the area with soap and rinse with water.

10 CONTAINED IN THIS BOX Do not ingest or inhale the test solution. If accidental ingestion occurs, please seek medical help immediately. 25 individually-wrapped 25 vials of buffer solution 25 individually-wrapped swabs 1 INSTRUCTION GUIDE test devices HOW DEEP SHOULD I INSERT THE SWAB INTO MY NOSTRILS? Inserting the swab into the nostril should be deep enough to collect samples for this test. Once you feel a slight resistance, proceed to gently collect your sample. Check the swab after collection to ensure the tip is covered in nasal secretion. HOW TO USE. WHAT DO I DO WITH THE TEST KIT AFTER READING THE RESULTS? Remove the test device and Tilt your head back. Gently insert the swab The buffer solution vial cap is Close the entire vial cap composed of two parts.