SARS-COV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab)

The SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2, Influenza A and Influenza B virus that causes COVID-19 and / or Influenza with self-collected nasal swab specimen. The test is intended for use in symptomatic individuals who are suspected of being infected with COVID-19 and / or Influenza A+B within the first 7 days of symptom onset.

This SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) is yet to be included on the Australian Register of Therapeutic Goods.

CONFIDENTLY TEST AT HOME

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

Combo Rapid Test

The SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein, Influenza A and Influenza B nucleoproteins antigens in human swab specimen.

AUSTRALIAN REGISTER OF THERAPEUTIC GOODS

Our COVID-19 Rapid antigen home test (oral Fluid) is yet to be included on the Australian Register of Therapeutic Goods, however, is currently being assessed.

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FAQ

The test is for the qualitative detection of SARS-CoV-2 and/or Influenza A/Influenza B antigens in self-collected swab specimens. A positive result indicates SARS-CoV-2 and / or Influenza A/Influenza B antigens present in the specimen.

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

You can read your result after 10 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 conduct the test upon waking in the morning.

SARS-CoV-2 and / or Influenza A/Influenza B antigen can be detected in acute respiratory tract infection, it is recommended to run the test when you are suspected of being infected with COVID-19 and / or Influenza A/Influenza B.

The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if inadequate sampling volume or the SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test gets wet before test performing, or if the number of extraction buffer drops are less than 3 or more than 4.

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 /Influenza A//Influenza B antigens. A positive results means it is very likely you have COVID-19 and / or /Influenza, 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 1-2 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 1-2 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 1-2 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).