The TGA has approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1st November 2021. See the instructions on how to use each test (provided in the table below) for more information on what types of samples the test can be used with (for example, nasal swab or saliva).
The TGA performance requirements for rapid COVID antigen self-tests are internationally aligned with the technical specifications published by the World Health Organization (WHO) and the European Commission. This includes a minimum clinical sensitivity of at least 80% (for samples collected within 7 days of symptom onset) and a minimum clinical specificity of at least 98%.
To provide an indication of the performance of the rapid self-tests for COVID-19 antigens, the following table includes information on the clinical sensitivity of each test. This is based on studies conducted by the manufacturer showing Percent Positive Agreement (PPA). PPP is the proportion of people who produced a positive test result using a rapid COVID-19 antigen self-test, compared to a positive result using a more sensitive laboratory PCR test.
The inclusion of this information does not represent TGA’s endorsement of any particular test, as all approved tests meet the performance requirements. Manufacturers’ sensitivity information is also included in the instructions provided with each test and can be viewed by clicking on the links in the table below.
A clinical sensitivity comment is assigned for each test as follows:
- Acceptable sensitivity: clinical sensitivity greater than 80% PPA
- High sensitivity: clinical sensitivity greater than 90% PPA
- Very high sensitivity: clinical sensitivity greater than 95% PPA
On/Go(TM) is the fast and easy-to-use FDA-cleared COVID-19 self-test and a companion app that guides you step-by-step through the testing process. In just 10 minutes, you’ll have the results you need to confidently return to work, school, sports and all the things you love to do, with the ability to store and share your family and test results from the intuitive interface.
The test is combined with a free and intuitive mobile app, available from the Apple and Google app stores, that provides step-by-step instructions and results management. With On/Go, feel confident in your COVID-19 status, quickly, without having to send samples to a lab, and without needing a prescription from your healthcare provider. Simply “tap, rub and press” to get your COVID-19 results.
- Results in 10 minutes (fastest available)
- US FDA Cleared for Over-the-Counter Use 95% Accuracy
- Detects all known variants of COVID-19 concern, including Delta Suitable for people with or without symptoms
- Minimally Invasive Lower Nasal Swab
- Exclusive companion mobile app makes it easy to take exams with step-by-step instructions
- Easily track your family and historical results and share them with anyone you choose with the On/Go app
- Indicated for children up to 2 years old when administered by an adult, and for all people over 14 years old to do it themselves.
- Concern for health
Fever; Shaking chills; Shortness of breath or difficulty breathing; Fatigue; Muscle or body pain; Headache; New loss of taste or smell; Throat pain; stuffy or runny nose; Nausea or vomiting; Diarrhea
FDA Emergency Use Authorization. The On/Go COVID-19 Antigen Self-Test is designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from persons with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when test twice for two or three days. with at least 24 hours and no more than 48 hours between tests. Store between 33.8 degrees F and 86 degrees F (1 degree C and 30 degrees C) until use.