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COVID-19 rapid antigen self-tests that are approved in Australia

24 November 2021

The TGA has approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021.

Please refer to the instructions on how to use each test (that are provided in the table below) for further information on what sample types the test can be used with (e.g. nasal swab or saliva).

The TGA's performance requirements for COVID rapid antigen self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO) and the European Commission. This includes a minimum clinical sensitivity of at least 80% (for specimens collected within 7 days of symptom onset) and a minimum clinical specificity of at least 98%.

To provide an indication of the performance of COVID-19 rapid antigen self-tests, the table below includes information on the clinical sensitivity of each test. This is based on the studies performed by the manufacturer which show the positive percent agreement (PPA). PPA is the proportion of individuals that produced a positive test result using a COVID-19 rapid antigen self-test, in comparison with a positive result that was obtained using a more sensitive laboratory PCR test.

The inclusion of this information does not represent TGA endorsement of a particular test as all approved tests meet the performance requirements. The manufacturer's sensitivity information is also included in the instructions provided with each test and can be viewed by clicking on the links in table below.

For each test a comment on the clinical sensitivity is assigned as follows:

  • Acceptable sensitivity - clinical sensitivity greater than 80% PPA
  • High sensitivity - clinical sensitivity greater than 90% PPA
  • Very high sensitivity - clinical sensitivity greater than 95% PPA

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.

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
Specimen type
Australian Sponsor (supplier) Manufacturer ARTG Clinical Sensitivity Date Approved

All Test COVID-19 Antigen Rapid Test (Oral Fluid) Self-Test (ICOV-802H) (pdf,366kb)

Oral fluid

AM Diagnostics

Hangzhou Alltest Biotech Co Ltd (China)

376310

High sensitivity

13 October 2021

All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) (ICOV-502H) Self-Test (pdf,649kb)

Nasal swab

AM Diagnostics

Hangzhou Alltest Biotech Co Ltd (China)

376310

Very high sensitivity

13 October 2021

CareStart COVID-19 Antigen Home Test (pdf,6.17Mb)

Nasal swab

Pantonic Pty Ltd

Access Bio Inc (United States of America)

342512

Acceptable sensitivity

21 October 2021

Ecotest COVID-19 Antigen Saliva Test kit (COV-S35Pen) (pdf,447kb)

Saliva

Emergence Technology Pty Ltd

Assure Tech (Hangzhou) Co Ltd (China)

372335

Acceptable sensitivity

22 October 2021

Hough COVID-19 Home Test (pdf,3.48Mb)

Nasal swab

Hough Pharma Pty Ltd

BIOHIT HealthCare (Hefei) Co Ltd (China)

345031

High sensitivity

18 October 2021

InnoScreen COVID-19 Antigen Rapid Test Device (Self Test) (pdf,1.15Mb)

Nasal swab

Innovation Scientific Pty Ltd

Innovation Scientific Pty Ltd (Australia)

336146

Acceptable sensitivity

28 October 2021

LYHER Novel Coronavirus (Covid-19) Antigen Test Kit (colloidal Gold) Self-Test (pdf,348kb)

Nasal swab

2San Pty Ltd

Hangzhou Laihe Biotech Co Ltd (China)

374507

Very high sensitivity

27 October 2021

My Covid Test Antigen Rapid Test (Oral Fluid) (ICOV-802H) Self-Test (pdf,366kb)

Oral fluid

AM Diagnostics

Hangzhou Alltest Biotech Co Ltd China

376310

High sensitivity

13 October 2021

OnSite COVID-19 Ag Self Test (pdf,2.22Mb)

Nasal swab

MD Solutions Australasia Pty Ltd

CTK Biotech Inc (USA)

332961

Very high sensitivity

3 November 2021

Orawell COVID-19 Ag Rapid saliva test device (Self-test) (pdf,1.68Mb)

Saliva

Motion One Pty Ltd

Jiangsu Well Biotech Co Ltd (China)

377136

High sensitivity

29 October 2021

Panbio COVID-19 Antigen Self-Test (pdf,886kb)

Nasal swab

Abbott Rapid Diagnostics Pty Ltd

Abbott Rapid Diagnostics Jena GmbH (Germany)

345192

Very high sensitivity

26 October 2021

RightSign COVID-19 Antigen Rapid Test Cassette (Nasal Swab) (pdf,1.06Mb)

Nasal swab

Medsupply Australia Pty Ltd

Hangzhou Biotest Biotech Co Ltd (China)

333344

High sensitivity

15 October 2021

SARS-CoV-2 Antigen Self Test Nasal (pdf,722kb)

Nasal swab

Roche Diagnostics Australia Pty Limited

SD Biosensor Inc (Korea - Republic of)

352250

Acceptable sensitivity

15 October 2021

TESTSEALABS COVID-19 Antigen Test Cassette (pdf,9.04Mb)

Nasal swab

Pharma Soul Pty Ltd

Hangzhou Testsea Biotechnology Co Ltd (China)

373151

High sensitivity

18 November 2021

V-Chek COVID-19 Antigen Saliva Test (pdf,5.27Mb)

Saliva

Cole Workwear PL

Guangzhou Decheng Biotechnology Co Ltd (China)

374065

Very high sensitivity

17 November 2021