Rapid COVID-19 Antigen Saliva Pen

The COVID-19 Antigen Lower Nasal Test Kit is a rapid chromatographic immunoassay and detects SARS-CoV-2 viral antigens in lower nasal samples through visual interpretation of colour development. Once the control line (C) appears, it means the test kit has performed properly.

The test results can be after 15 minutes as long as a coloured band or line appears in the Control region (C). Do not read result after 30 minutes.

The intensity of the colour in the Test area (T) varies. However, any shade in the Test area (T) should be considered positive.

The results will only give accurate results as far as carefully following the instructions. However, the result can be incorrect. Not pushing the lower nasal sample collector all the way into the extraction tube, insufficient sample size, or expired tests are the most likely reasons for the missing. Non-SARS-CoV-2 coronavirus viral strains or other interference factors may cause a preliminary Positive Result.

If you get a positive result, it indicates a possible SARS-CoV-2 infection. A positive result also means you are at risk of infecting others, please contact a doctor or the local health department immediately for a confirmatory PCR test and for follow-up clinical care. Call your State or Territory COVID hotline for further advice

Negative results do not completely rule out SARS-CoV-2 infection. Please continue to comply with all applicable rules regarding contact with others and protective measures. An infection can also be present if the test is negative. In case of suspicion, being ina high risk setting or where there is an occupational risk or other requirement, repeat the tests after 1-3 days or have a RT-PCR test, as the coronavirus cannot be accurately detected in all phases of an infection

For advice on how to seek medical assistance or get RT-PCR confirmation tested for COVID-19 please contact your state or territory health authority. Contact TGA to report an issue via the Users Medical Device Incident Report on email iris@tga.gov.au or call 1800 809 361