COVID-19 Antigen Rapid Test (Nasal Swab) is a single-use test kit

INTENDED USE

The COVID-19 Antigen Rapid Test (Nasal Swab) 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 (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in human swab 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 nasal passage. 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.

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