COVID Test Kits

TGA-Approved Rapid COVID Test Kits in Australia

Therapeutic Goods Administration (TGA) is Australia’s government agency that is primarily in charge of examining, evaluating and keeping track of commodities classified as therapeutics. To ensure the safety and health of Australians, they regulate drugs, medical equipment and biologicals.

As we are still in the midst of COVID–19 pandemic, a lot of rapid COVID test kits have been circulating in the online marketplace with their authenticity being unknown. With this being said, these unevaluated test kits might put you and your loved ones in peril. Hence, do more harm than good.

In this blog post, we will enlist and take a closer look at the TGA-approved rapid COVID test kits in the country.

How Do Rapid COVID-19 Tests Undergo Approval?

According to the TGA, they had approved the COVID-19 self-tests (home use tests) for supply in Australia. The sale of COVID-19 nucleic acid amplification self-tests (for use at home) is also authorised in Australia. Instead of the spike protein picked up by fast antigen testing when the infection is active, nucleic acid amplification assays find the genetic material from the SARS-CoV-2 virus.

The European Commission and WHO have also produced technical specifications that correspond to the TGA’s performance requirements for COVID-19 self-tests. This calls for a clinical sensitivity of at least 80% (for samples taken within 7 days of symptom onset) and a clinical specificity of at least 98% for quick antigen testing.

This is based on manufacturer studies that demonstrate the positive percent agreement (PPA). PPA measures how many individuals are tested positive for COVID-19 using a fast antigen self-test against how many individuals are tested positive using a more accurate PCR test.

These aforementioned products had undergone the following quality tests to ensure efficacy and safety among Australians:

  • The acceptable sensitivity—Clinical sensitivity which is greater than 80% PPA
  • The high sensitivity—Clinical sensitivity which is greater than 90% PPA
  • The very high sensitivity—Clinical sensitivity which is greater than 95% PPA

TGA-Approved Rapid COVID Test Kits

Here are some of the TGA-approved rapid COVID test kits:

  • TouchBio SARS-CoV-2 & FLU A/B Antigen Combo Test by Touch Biotechnology Pty Ltd

This combo-style antigen test is manufactured by Vitrosens Biyoteknoloji LTD STI in Turkey. It was then approved on 7 September 2022. TouchBio SARS-CoV-2 & FLU A/B Antigen Combo Test detects the presence of both SARS-CoV-2 and  Flu A/B viruses through nasal swabbing. 

  • All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Self-Test (INCP-502H) by AM Diagnostics

This nasal swab is manufactured by Hangzhou Alltest Biotech Co Ltd in China. It’s one of the rapid COVID test kits that had been declared safe to use as it was approved on 13 October 2021. According to its packaging, it’s a rapid test for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens present in nasal swab specimens. It is also prescribed to symptomatic patients infected within 7 days of symptom onset.

  • Clungene Covid-19 Antigen Rapid Test (for self-testing) by APAC Security Pty Ltd

With high clinical sensitivity, Clungene Covid-19 Antigen Rapid Test (for self-testing) is manufactured by Hangzhou Alltest Biotech Co Ltd in China. Just like the second TGA-approved rapid COVID test kit, it was approved on 13 October 2021. Through nasal swab self-test, you will be able to get accurate results.

  • Novel Coronavirus (SARS-Cov-2) Antigen Rapid tests device (nasal swab) by Dexcon Pty Ltd

This nasal swab rapid COVID antigen test kit is manufactured by Hangzhou Realy Tech Co Ltd in China. It was approved for safe public use on 4 February 2022. The Novel coronavirus (SARS-Cov-2) Antigen Rapid tests device (nasal swab) by Dexcon Pty Ltd provides high clinical sensitivity and ensures high accuracy in detecting the SARS-Cov-2 virus.

  • SureScreen SARS-CoV-2 Antigen Rapid test Cassette (Nasal Swab) (Gold) by SureScreen Australia Pty Limited

Manufactured by SureScreen Diagnostics Ltd in the United Kingdom, this nasal swab test kit also provides accurate results. The TGA approved the use of this rapid COVID test kit on 29 April 2022.

To view the full list of TGA-approved rapid COVID test kits, click here.

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