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Which COVID-19 home testing kits are approved by the TGA?

Chris Jager
Posted:
News
COVID-19 test kits Australia_Supplied_1800x1000

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

NameTypePPA sensitivitySupplier
All Test COVID-19 Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H)Oral fluidHigh sensitivityAM Diagnostics
All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) (ICOV-502H) Self-TestNasal swabVery high sensitivityAM Diagnostics
CareStart COVID-19 Antigen Home TestNasal swabAcceptable sensitivityPantonic Pty Ltd
Cellife Covid-19 Antigen Test Cassette for self-testingNasal swabVery high sensitivityAustralia Health Products Central Pty Ltd
Clungene Covid-19 Antigen Rapid Test for self-testingNasal swabVery high sensitivityAPAC Security Pty Ltd
Ecotest COVID-19 Antigen Saliva Test kit (COV-S35Pen)SalivaAcceptable sensitivityEmergence Technology Pty Ltd
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)Nasal swabVery high sensitivityAusDiagnostics Pty Ltd
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)Nasal swabVery high sensitivityOrvato Healthcare Pty Ltd
Hough COVID-19 Home TestNasal swabHigh sensitivityHough Pharma Pty Ltd
Innoscreen COVID-19 Antigen Test Device (Self Test)Nasal swabAcceptable sensitivityInnovation Scientific Pty Ltd
JusChek COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H Self TestOral fluidHigh sensitivityCompliance Management Solutions
JusChek SARS-CoV-2 Antigen Rapid Test (Nasal Swab) INCP-502H Self TestNasal swabHigh sensitivityCompliance Management Solutions
LYHER Novel Coronavirus (Covid-19) Antigen Test Kit (colloidal Gold) Self-TestNasal swabVery high sensitivity2San Pty Ltd
My Covid Test Antigen Rapid Test (Oral Fluid) (ICOV-802H) Self-TestOral fluidHigh sensitivityAM Diagnostics
OnSite COVID-19 Ag Self TestNasal swabVery high sensitivityMD Solutions Australasia Pty Ltd
Orawell COVID-19 Ag Rapid saliva test device (Self-test)SalivaHigh sensitivityMotion One Pty Ltd
Panbio COVID-19 Antigen Self-TestNasal swabVery high sensitivityAbbott Rapid Diagnostics Pty Ltd
Rapid SARS-COV-2 Antigen Test Card Self-testNasal swabVery high sensitivityMedsupply Australia Pty Ltd
RightSign COVID-19 Antigen Rapid Test Cassette (Nasal Swab)Nasal swabHigh sensitivityMedsupply Australia Pty Ltd
SARS-CoV-2 Antigen Self Test NasalNasal swabAcceptable sensitivityRoche Diagnostics Australia Pty Limited
TESTSEALABS COVID-19 Antigen Test CassetteNasal swabHigh sensitivityPharma Soul Pty Ltd
V-Chek COVID-19 Antigen Saliva TestSalivaVery high sensitivityCole Workwear PL

You can purchase TGA-approved COVID-19 self-tests from a variety of pharmacies, supermarkets and online stores including Rapid Proof, Chemistworks, AUSTiC, Blooms, Kogan, Coles and Woolworths.

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

Need more COVID-19 news? Head to our COVID home testing information hub and guide to wearing masks in Australia.

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