COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit

INTENDED USE

The COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid. This test is designed for home use with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19. The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary results only, the final confirmation should be based on clinical diagnostic results.

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhoea are found in a few cases.

PRINCIPLE

The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Antigens in human oral fluid specimen.

WARNING

1. Read the entire package insert prior to performing test.
2. For self-testing in vitro diagnostic use only.
3. The test is for one time use only, do not reuse the test. Do not use after expiration date.
4. Do not eat, drink or smoke in the area where the specimens or kits are handled.
5. Do not drink the buffer in the kit. Carefully handle the buffer and avoid it contacting skin or eyes, rinse with plenty of running water immediately if contacting.
6. Do not use test if pouch is damaged.
7. Wash hands thoroughly before and after handling.
8. If the result is preliminary positive, share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements.
9. Test for children and young people should be used with an adult.
10. The used test should be discarded according to local regulations.

Q&A

1. How do I know if the Test worked well?
COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens present in human oral fluid. When the control line(C) appears, it means the test unit is performing well.

2. How soon can I read my results?
You can read your results after 15 minutes as long as a coloured line has appeared next to the Control region(C), do not read result after 20 minutes.

3. When is the best time to run the test?
Test can be done at any time of the day. However It is recommended to collect the first oral fluid in the morning.

4. Can the result be wrong? Are there any factors that can affect the test result?
The results will only give accurate results as far as the fresh human oral fluid is used and followed the instructions carefully. Nevertheless, the result can be incorrect. Non-SARS-CoV-2 coronavirus strains or other interference factors may cause a preliminary Positive Result.

5. How to read the test if the colour and the intensity of the lines are different?
The colour and intensity of the lines have no importance for result interpretation. The test should be considered as Positive whatever the colour intensity of the test line (T) is.

6. What do I have to do if the result is positive?
A positive result means the presence of SARS-CoV-2 antigens. A positive results means it is very likely you have COVID-19 and the result should be confirmed. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner / doctor or the local health department in accordance with the instructions of your local authorities. Your test result will be checked by a PCR confirmation test and you will be explained the next steps.

7. What do I have to do if the result is negative?
A negative result means that you are negative or that the viral load is too low to be recognized by the test. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative.
If you experience symptoms such as headaches, migraines, fever, loss of sense of smell and taste, contact the nearest medical facility using the rules of your local authority. In addition, you can repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus cannot be precisely detected in all phases of an infection. Distance and hygiene rules must still be observed. Even with a negative test result, distance and hygiene rules must be observed, mitigation/traveling, attending events and etc should follow your local COVID guidelines/requirements.

TESTING
Before Testing
Do not place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection. Wash your hands with soap and water for at least 20 seconds before testing. If soap and water are not available, use hand sanitizer with at least 60% alcohol.

Step 1: Specimen collection
Remove the funnel and plastic tube; fit the funnel onto the tube.
Deeply cough 3-5 times.

Note: Wear a face mask or cover your mouth and nose with a tissue when you are coughing and keep distance with other people.
Gently spit oral fluid into the funnel. The oral fluid (non-bubble) should just reach the height of scale line.

Note: If there’s not enough oral fluid collected, repeat the above specimen collection steps. Place the used funnel into the plastic Biosafety Bag

Step 2: Specimen preparation
Tear to open the buffer and add entire buffer to the tube with oral fluid. Fit the tube tip onto the tube. Gently squeeze the tube 10-15 times to mix well.

Step 3: Testing
Remove the test device from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch. Place the test cassette on a flat and level surface. Invert the tube and add 2 drops of solution to the specimen well(S) of the test device and then start the timer. Do not move the test cassette during test developing.

Step 4:
Read the result at 15 minutes. Do not interpret the result after 20 minutes. After test is completed, place the all the components of the test kit in plastic Biosafety Bag and dispose according to local regulation. Do not reuse any used components of the kit. Wash hands thoroughly after test disposal.

READ RESULTS

Please share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements.
POSITIVE:* Two coloured lines appear. One coloured line should be in the control region (C) and another coloured line should be in the Test region (T).
NOTE: The intensity of the colour in the test line region (T) will vary based on the amount of SARS-CoV-2 antigen present in the sample. So any shade of colour in the test region (T) should be considered positive. A positive results means it is very likely you have COVID-19, but the positive samples should be confirmed. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner/doctor or the local health department in accordance with the instructions of your local authorities. Your test result will be checked by a PCR confirmation test and you will be explained the next steps.

NEGATIVE: One coloured line appears in the control region (C). No apparent coloured line appears in the test line region (T). You are unlikely to have COVID-19. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative.
If you experience symptoms such as headaches, migraines, fever, loss of sense of smell or taste, contact the nearest medical facility according to the rules of your local authority. In addition, you can repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus cannot be precisely detected in all phases of an infection. Even with a negative test result, distance and hygiene rules must be observed, mitigation/traveling, attending events and etc should follow your local COVID guidelines/requirements.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test or contact with your doctor or a COVID-19 test centre.