We have approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021.
Some, but not all manufacturers of approved rapid antigen tests (RATs) have extended the shelf-life of their products. We will update the table below as we receive further information on the extended shelf-life from the sponsor.
This information is provided for health services and distributors of these tests to verify whether we have accepted a shelf-life extension for that RAT, so they can contact their supplier to clarify the expiry date for their stock of RATs.
This information is not intended for users or the general public to determine the expiry date of their RAT. The list does not specify the expiry date for individual batches of RATs from that manufacturer.
Users are advised to not use a RAT after its expiry date (or use by date). You should contact the customer support number on the 'Instructions For Use' if you are unsure about using the test or its expiry date.
It is important to follow the instructions for the specific test you do. Instructions for each test are provided in the below table.
COVID-19 rapid antigen self-tests (for home use) provides more information on:
- where to buy rapid antigen self-tests, what to look for and how to use them correctly
- what to do if you are travelling overseas with a COVID-19 self-test
- reporting a problem or issue with a COVID-19 self-test
- how you can legally supply and advertise COVID-19 self-tests in Australia.
COVID-19 nucleic acid amplification self-tests (for home use) are also approved for supply in Australia. Nucleic acid amplification (NAA) tests detect the genetic material from the SARS-CoV-2 virus, rather than the spike protein detected by rapid antigen tests during active infection.
Our performance requirements for COVID-19 self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO) and the European Commission. For rapid antigen tests, this includes a clinical sensitivity of at least 80% (for specimens collected within 7 days of symptom onset) and a clinical specificity of at least 98%.
COVID-19 self-tests (home use) approved by TGA
*Clicking on the name of the test will link to the instructions on how to use it.
Easy Read factsheets on how to do a rapid test have been published by the Department of Health:
- How to do a rapid antigen test from your nose - external site
- How to do a rapid antigen test with your saliva - external site
PDF Instructions on how to use the test are provided as a supplementary resource for the visually read tests listed below and do not meet disability access requirements.
Name of self-test* and how to use the test | Sample type used | Australian Sponsor (supplier) | Manufacturer | ARTG | Date Approved | Shelf Life |
---|---|---|---|---|---|---|
2019 nCoV Ag Test (Latex Chromatography Assay) - Self - test (pdf 1.3Mb) (Rapid antigen test) | Nasal swab | BGI Health (AU) Company Pty Ltd | Innovita (Tangshan) Biological Technology Co Ltd (China) | 387550 | 27 April 2022 | 18 Months |
2019-nCoV Ag Rapid Test Kit (Immunochromatography for self-testing) (pdf,1.18Mb) (Rapid antigen test) | Nasal swab | Big Start Pty Ltd | Guangzhou Decheng Biotechnology Co Ltd (China) | 387020 | 12 April 2022 | 24 Months |
2SAN COVID-19 & Influenza A/B Antigen Nasal Test Kit for Self-testing (pdf 14.1MB) (Combination Rapid antigen self test) | Nasal swab | 2San Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 462767 | 25 September 2024 | 24 Months |
2SAN COVID-19 Antigen Nasal Test Kit for Self-Testing (pdf 13.21MB) (Rapid antigen test) | Nasal swab | 2San Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China)
| 462948 | 26 September 2024 | 24 Months |
AHPC COVID-19 / Influenza A&B Antigen Test Kit (Combination Rapid antigen self test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 414738 | 06 December 2024 | 24 Months |
AHPC COVID-19 / RSV / Influenza A&B Antigen Test Kit (Combination Rapid antigen self test) | Nasal swab | Australia Health Products Central Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 427686 | 22 November 2024 | 24 Months |
All Test COVID-19 Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H) (pdf,366kb) (Rapid antigen test) | Oral fluid | AM Diagnostics | Hangzhou Alltest Biotech Co Ltd (China) | 376310 | 13 October 2021 | 24 Months (extended) |
All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Self-Test (INCP-502H) (pdf,649kb) (Rapid antigen test) | Nasal swab | AM Diagnostics | Hangzhou Alltest Biotech Co Ltd (China) | 376310 | 13 October 2021 | 24 Months (extended) |
Beright SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) (pdf,248kb)
| Nasal swab | Compliance Management Solutions | Hangzhou Alltest Biotech Co Ltd (China) | 443914 | 18 March 2024 | 24 Months |
Biopen COVID-19 Antigen Nasal Test Kit for Self-Testing (pdf,354kb) (Rapid antigen test) | Nasal swab | Emergence Technology Pty Ltd | Assure Tech (Hangzhou) Co Ltd (China) | 372335 | 5 May 2022 | 30 Months (extended) |