Which COVID-19 home testing kits are approved by the TGA?
The TGA is warning consumers to be cautious when purchasing products claiming to be home self-tests for COVID-19.
Australian shoppers can now buy COVID-19 self-tests (home use) from local sellers – but only if the product in question has Therapeutic Goods Administration (TGA) approval.
For those unfamiliar with therapeutic goods legislation, the advertising and supply of self-tests for serious infectious diseases is prohibited unless explicitly approved by the TGA. This helps to ensure that all tests being sold are actually fit for purpose.
"Home tests may give a false positive or false negative result, which could be extremely dangerous for yourself and others if relied on," the TGA said in a statement. It's therefore imperative that you are using a TGA-approved testing kit.
There are currently 23 self-test products that have been approved in Australia by the TGA. Here's the list, courtesy of the TGA website:
TGA-approved COVID-19 rapid antigen self-tests
|All Test COVID-19 Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H)||Oral fluid||High sensitivity||AM Diagnostics|
|All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) (ICOV-502H) Self-Test||Nasal swab||Very high sensitivity||AM Diagnostics|
|CareStart COVID-19 Antigen Home Test||Nasal swab||Acceptable sensitivity||Pantonic Pty Ltd|
|Cellife Covid-19 Antigen Test Cassette for self-testing||Nasal swab||Very high sensitivity||Australia Health Products Central Pty Ltd|
|Clungene Covid-19 Antigen Rapid Test for self-testing||Nasal swab||Very high sensitivity||APAC Security Pty Ltd|
|Ecotest COVID-19 Antigen Saliva Test kit (COV-S35Pen)||Saliva||Acceptable sensitivity||Emergence Technology Pty Ltd|
|Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)||Nasal swab||Very high sensitivity||AusDiagnostics Pty Ltd|
|Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)||Nasal swab||Very high sensitivity||Orvato Healthcare Pty Ltd|
|Hough COVID-19 Home Test||Nasal swab||High sensitivity||Hough Pharma Pty Ltd|
|Innoscreen COVID-19 Antigen Test Device (Self Test)||Nasal swab||Acceptable sensitivity||Innovation Scientific Pty Ltd|
|JusChek COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H Self Test||Oral fluid||High sensitivity||Compliance Management Solutions|
|JusChek SARS-CoV-2 Antigen Rapid Test (Nasal Swab) INCP-502H Self Test||Nasal swab||High sensitivity||Compliance Management Solutions|
|LYHER Novel Coronavirus (Covid-19) Antigen Test Kit (colloidal Gold) Self-Test||Nasal swab||Very high sensitivity||2San Pty Ltd|
|My Covid Test Antigen Rapid Test (Oral Fluid) (ICOV-802H) Self-Test||Oral fluid||High sensitivity||AM Diagnostics|
|OnSite COVID-19 Ag Self Test||Nasal swab||Very high sensitivity||MD Solutions Australasia Pty Ltd|
|Orawell COVID-19 Ag Rapid saliva test device (Self-test)||Saliva||High sensitivity||Motion One Pty Ltd|
|Panbio COVID-19 Antigen Self-Test||Nasal swab||Very high sensitivity||Abbott Rapid Diagnostics Pty Ltd|
|Rapid SARS-COV-2 Antigen Test Card Self-test||Nasal swab||Very high sensitivity||Medsupply Australia Pty Ltd|
|RightSign COVID-19 Antigen Rapid Test Cassette (Nasal Swab)||Nasal swab||High sensitivity||Medsupply Australia Pty Ltd|
|SARS-CoV-2 Antigen Self Test Nasal||Nasal swab||Acceptable sensitivity||Roche Diagnostics Australia Pty Limited|
|TESTSEALABS COVID-19 Antigen Test Cassette||Nasal swab||High sensitivity||Pharma Soul Pty Ltd|
|V-Chek COVID-19 Antigen Saliva Test||Saliva||Very high sensitivity||Cole Workwear PL|
Prices vary depending on the product and provider, but you can expect to pay between $30 and $50 for most kits. You can compare prices from different retailers in our Where to buy COVID tests guide – all of which have been approved by the TGA.
About COVID-19 home testing
A rapid antigen test is a screening tool used to detect COVID-19 in asymptomatic humans. Similar to a pregnancy test, they can be quickly taken at home without the need for lab equipment or a health professional. Instead, you simply place a saliva sample or nasal swab into a chemical solution and wait for the results to show up. This usually takes less than 20 minutes.
Rapid antigen test are not as accurate as a PCR test, with a higher chance of a false negative. If you receive a positive result or are suffering from COVID-like symptoms, you will need to arrange a PCR COVID test from a clinic and immediately self-isolate.
COVID-19 testing kits require TGA approval and inclusion in the Australian Register of Therapeutic Goods (ARTG) before they can be legally sold in Australia. You can purchase them from the above stores starting on 1 November 2021. Stock is expected to be limited, so grab yourself a kit while they are still available.
To learn more about the science, head to our COVID-19 home testing hub.
More on COVID-19 testing
With COVID still a component of daily life, take a look at the face mask restrictions that affect you and your family.Read more…
Here's how you can most easily and affordably secure rapid antigen tests in Sydney and NSW.Read more…
COVID cases are surging so now's the time to refresh your memory on the steps you can take to stay protected from the experts.Read more…
COVID is once again on the rise, so find out whether surgical masks or P2 masks are best to protect you and your family.Read more…
With a concerning surge in COVID-19 cases in Australia, it's time to decide which style of face mask is right for you.Read more…