COVID-19 ANTIGEN TEST
Intended Use:
The COVID-19 Antigen 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 Test (Oral Fluid) obtain a preliminary result only, the final confirmation should be based on clinical diagnostic results
Sensitivity: 90%
Specificity: 100%
Information:
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 diarrhea are found in a few cases.
- Update self test result to MySejahtera
- Kemaskini keputusan ujian kendiri ke MySejahtera
Product Description
| No | Product Desc | Order Qty | Format | Catalogue No | Specimen |
|---|---|---|---|---|---|
| 1 | Covid-19 Antigen Test | Please Contact For Details | Cassette | ICOV-802H | Oral Fluid |
Instructions for Use (IFU)
Test Procedure & Result Interpretation
* Do not eat, drink or smoke at least 30 minutes before the test
FAQ
- 1. How do I know if the Test worked well ?
- 2. How soon can I read my results?
- 3. When is the best time to run the test?
- 4. Can the result be wrong? Are there any factors that can affect the test result?
- 5. How to read the test if the color and the intensity of the lines are different?
- 6. What do I have to do if the result is positive?
- 7. What do I have to do if the result is negative?
COVID-19 Antigen 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.
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.
Test can be done at any time of the day. However It is recommended to collect the first oral fluid in the morning.
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.
The color and intensity of the lines have no importance for result interpretation. The test should be considered as Positive whatever the color intensity of the test line (T).
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.
Alternatively, report to MOH via MySejahtera App. The steps to do this: Go to Helpdesk, press ‘Start’ and click ‘Section F’ which indicates I am Covid-19 positive and would like to report my result.
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.