SARS-COV-2 Antigen Home Test (Oral Fluid)

Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals for self-testing by lay persons (saliva).

ARTG No: 401127

Product Name: Severe acute respiratory syndrome-associated coronavirus IVDs.

Plus Daily SARS-COV-2 Antigen Home Test (Oral Fluid) is a chromatographic immunoassay for the qualitative detection of N antigen from SARS-CoV-2 present in human saliva within the first 7 days of symptom onset. This test is for self-testing purposes, as an aid to diagnosis of SARS-CoV-2 infection.

CONFIDENTLY TEST AT HOME

Our Covid Test is a fast and convenient way to get tested from the comfort of your own home, with a quick turnaround time for results.

NON- INVASIVE TESTING (Saliva, oral fluid)

As opposed to uncomfortable nasal swabs, our tests only require saliva samples with minimal discomfort for users.

AUSTRALIAN REGISTER OF THERAPEUTIC GOODS

ARTG No: 401127

Product Name: Severe acute respiratory syndrome-associated coronavirus IVDs.

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FAQ

When the control line (C) appears, it means the test unit is performing as intended.

You can read your result after 15 minutes as long as a coloured line has appeared next to the Control region (C). Do not read your result after 20 minutes.

Test within the first 7 days of symptom onset. Testing can be done at any time of the day, however, it is recommended to collect oral fluid/ conduct the test upon waking in the morning.

The results will only give accurate results with human oral fluid collected at the time of testing, and provided the instructions are followed carefully. There is a risk of a false negative result, particularly if testing is not performed within the first 7 days of symptom onset. The test is less reliable in the later phase of infection and in asymptomatic individuals. A negative result does not rule out infection with another type of respiratory virus. If you experience symptoms such as headaches, migraines, fever, loss of sense of smell or taste, contact the nearest medical facility according to guidelines provided by your local authority. Even with a negative test result, distance yourself and observe hygiene rules.

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.

A positive result means the presence of SARS-CoV-2 antigens. A positive result means it is very likely you have COVID-19, please follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary, and if unwell seek medical assistance.

Warning:

There is a risk of a false negative result, particularly if testing is not performed within the first 7 days of symptom onset.
The test is less reliable in the later phase of infection and in asymptomatic individuals.
A negative result does not rule out infection with another type of respiratory virus.

A negative result means that you are negative for COVID-19, or that the viral load is too low to be recognised 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 that 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 using the rules of your local authority.

In addition, you can repeat the test with a new device.

In case of suspicion, repeat the test after 1-3 days, as coronavirus cannot be precisely detected in all phases of an infection. Social distancing and hygiene recommendations must still be followed.

In relation to migration/traveling, attending events, etc, you should follow your local COVID guidelines / requirements.

In case of suspicion, repeat the test after 1-3 days, as coronavirus cannot be precisely detected in all phases of an infection. Social distancing and hygiene recommendations should be followed.

Repeat testing is recommended (e.g. within 1-3 days) if there is an ongoing suspicion of infection, being in a high risk setting, or where there is an

occupational risk or other requirement.

After completing your test, place all components into the plastic biohazard specimen bag provided and seal. You can then dispose of this sealed bag in your household waste (not recycling) or according to your local guidelines.

For advice on how to seek medical help or get tested for coronavirus (COVID-19) you can contact your state or territory health authority, or call the coronavirus (COVID-19) helpline on 1800 020 080 at any time. Alternatively, visit the website: https://www.australia.gov.au/phone-contacts.

Contact the TGA to report poor performance or usability issues in the self-test environment (report an issue via the Users Medical Device Incident Report, email: iris@tga.gov.au or call 1800 809 361).