| Summary | Detection of specific Antigen of Covid-19 within 15 minutes |
| Principle | One-step immunochromatographic assay |
| Detection Targets | COVID-19 Antigen |
| Sample | oropharyngeal swab, nasal swab, or saliva |
| Reading time | 10~ 15 minutes |
| Quantity | 1 box (kit) = 1 devices (Individual packing) |
| Contents | 1 Test Cassettes: each cassette with desiccant in individual foil pouch 1 Sterilized Swabs: single use swab for specimen collection 1 Extraction Tubes: containing 0.4mL of extraction reagent 1 Dropper Tips 1 Package Insert |
| Caution | Use within 10 minutes after opening Use appropriate amount of sample (0.1 ml of a dropper) Use after 15~30 minutes at RT if they are stored under cold circumstances Consider the test results as invalid after 10 minutes |
INTENDED USE The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in anterior-nasal swab from individuals who are suspected of COVID-19. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasal swab during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management. COMPOSITION Materials Provided Test Cassette: each cassette with desiccant in individual foil pouch Sterilized Swabs: single use swab for specimen collection Extraction Tubes: containing 0.5 mL of extraction reagent Dropper Tip Package Insert Timer Materials Required but not Provided
| [Preparing to do the test] |
| 1. Keep a clock, timer or stopwatch at hand. |
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| Instructions for Use | Swab | Extraction Reagent Tube | Dropper Tip |
Note: Only open the foil packaging of the test cassette when you are ready to carry out the test. Use the test cassette within 1 hour.
Wash your hands in soapy water and dry thoroughly.
1. Open Extraction Reagent Tube Carefully tear off the sealed foil film on the extraction reagent tube.2.Insert Tube into Box Gently press the tube through the perforated hole in the box.
3.Remove the Swab Open the swab package at the stick end. Note: Keep fingers away from swab tip. 
Take out the swab.4. Swab the Left Nostril Gently insert the entire tip of the swab, app. 2.5 cm into the left nostril.
Firmly brush the swab against the inside of the nostril in a circular motion 5 times or more.
(Approximately 1.5 times the length of the swab tip)5. Swab the Right Nostril Remove the swab from the left nostril and insert it into right nostril about 2.5 cm.
Firmly brush the swab against the inside of the nostril in a circular motion 5 times or more.
- CHECK!
- You should swab both nostrils.
- Note: A false negative result may occur if sample collection is not thoroughly undertaken.
7.Rotate the Swab 5 Times Rotate the swab at least 5 times while pressing the swab tip against the bottom and the sides of the tube.
Let the tip of the swab soak in the tube for 1 minute.
8.Remove the Swab Remove the swab while squeezing the sides of the tube against the swab, to release the liquid from the swab.
Cover the tube with the provided tip tightly and insert the tube back into the box.
9.Take out the Test Cassette from the pouch Open the sealed pouch and take out the test cassette.
Note: Test cassette must lay FLAT on the table during the entire testing. 10.Add Sample to the Sample Well Hold the tube vertically over the Sample Well - not at an angle.
Add 3 drops from the tube into the Sample Well by gently squeezing the sides of the tube.Note 1: A false negative result may occur if less than 3 drops of sample is used. (Approximately 1.5 times the length of the swab tip) Note 2: The result will not be affected if 1-2 more drops of sample are accidently added – as long as you can read a C-line (see Read result below).
11. Timing Start the clock / stopwatch or timer.12. Wait 15 Minutes Read the test result at 15-20 minutes, DO NOT read the result after 20 minutes.
Negative Result
A positive test result indicates that you are likely to carry the COVID-19 disease. Contact your State or Territory Coronavirus testing services to get a laboratory PCR test as soon as possible, and follow local guidelines for self-isolation to avoid spreading the virus to others.
Positive Result Two lines appear. One coloured line appears at the control region (C), and another appears at the test region (T).One coloured line appears at the control region (C), and no line appears at the test region (T).
Note: If a C-line does not appear, the test result is invalid regardless of the appearance of a T-line or not. If a C-line does not appear, you need to retest with a new test cassette or contact your State or Territory Coronavirus testing services to get a laboratory PCR testDispose of the used test kit
Collect all parts of the test kit and place in the waste bag , then dispose the waste according to the local regulation. Wash your hands thoroughly after handling