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 any 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 9 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
|Name of self-test||Australian supplier||Manufacturer|
|All Test COVID-19 Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H)||AM Diagnostics||Hangzhou Alltest Biotech Co Ltd (China)|
|All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) (ICOV-502H) Self-Test||AM Diagnostics||Hangzhou Alltest Biotech Co Ltd (China)|
|CareStart COVID-19 Antigen Home Test||Pantonic Pty Ltd||Access Bio Inc (United States of America)|
|Ecotest COVID-19 Antigen Saliva Test kit (COV-S35Pen)||Emergence Technology Pty Ltd||Assure Tech (Hangzhou) Co Ltd (China)|
|Hough COVID-19 Home Test||Hough Pharma Pty Ltd||BIOHIT HealthCare (Hefei) Co Ltd (China)|
|My Covid Test Antigen Rapid Test (Oral Fluid) (ICOV-802H) Self-Test||AM Diagnostics||Hangzhou Alltest Biotech Co Ltd China|
|RightSign COVID-19 Antigen Rapid Test Cassette (Nasal Swab)||Medsupply Australia Pty Ltd||Hangzhou Biotest Biotech Co Ltd (China)|
|Panbio COVID-19 Antigen Self-Test||Abbott Rapid Diagnostics Pty Ltd||Abbott Rapid Diagnostics Jena GmbH (Germany)|
|SARS-CoV-2 Antigen Self Test Nasal||Roche Diagnostics Australia Pty Limited||SD Biosensor Inc (Korea - Republic of)|
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 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.
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