You are here

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

6 May 2022

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

It is important to follow the instructions for the specific test you do. Instructions for each test are provided in the below table.

COVID-19 rapid antigen self-tests (for home use) provides more information on:

  • where to buy rapid antigen self-tests, what to look for and how to use them correctly
  • what to do if you are travelling overseas with a COVID-19 self-test
  • reporting a problem or issue with a COVID-19 self-test
  • how you can legally supply and advertise COVID-19 self-tests in Australia.

The TGA's performance requirements for COVID-19 rapid antigen self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO) and the European Commission. This includes a clinical sensitivity of at least 80% (for specimens collected within 7 days of symptom onset) and a clinical specificity of at least 98%.

The below table provides an indication of the performance of COVID-19 rapid antigen self-tests, including 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 who tested positive to COVID-19 using a rapid antigen self-test, compared to those who tested positive to COVID-19 using a more sensitive 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.

Easy Read factsheets on how to do a rapid test have been published by the Department of Health:

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

2019-nCoV Ag Rapid Test Kit (Immunochromatography for self-testing) (pdf,1.56Mb)

Nasal swab

Big Start Pty Ltd

Guangzhou Decheng Biotechnology Co Ltd (China)

387020

Very high sensitivity

12 March 2022

2019 nCoV Ag Test (Latex Chromatography Assay) - Self - test (pdf 1,327kb)

Nasal swab

BGI Health (AU) Company Pty Ltd

Innovita (Tangshan) Biological Technology Co Ltd (China)

38750

Very high sensitivity

27 April 2022

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) Self-Test (INCP-502H) (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

Cellife Covid-19 Antigen Test Cassette for self-testing (pdf,784Kb)

Nasal swab

Australia Health Products Central Pty Ltd

Hangzhou Testsea Biotechnology Co Ltd (China)

375418

Very high sensitivity

12 January 2022

Clungene Covid-19 Antigen Rapid Test for self-testing (pdf,703kb)

Nasal swab

APAC Security Pty Ltd

Hangzhou Clongene Biotech Co Ltd (China)

333341

Very high sensitivity

7 January 2022

Covid-19 Ag Home Test (pdf,10.4Mb)

Nasal swab

Nature's Family Australia Pty Ltd

GenBody Inc (Korea - Republic of)

383887

Acceptable sensitivity

11 February 2022

COVIFIND COVID-19 Antigen Self-Test (pdf,1Mb)

Nasal swab

Safe Interact Pty Ltd

Meril Diagnostics Pvt Ltd (India)

387390

Very high sensitivity

22 April 2022

Ecotest COVID-19 Antigen Nasal Test Self Test (pdf,451kb)

Nasal swab

Emergence Technology Pty Ltd

Assure Tech (Hangzhou) Co Ltd (China)

372335

Very high sensitivity

5 May 2022

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

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,422KB)

Nasal swab

AusDiagnostics Pty Ltd

Acon Biotech (Hangzhou) Co Ltd (China)

382031

Very high sensitivity

6 January 2022

GSD NovaGen SARS CoV-2 Ag Rapid Test (Nasal swab) Self-testing (pdf,297kb)

Nasal swab

Eurofins Technologies Australia Pty Ltd

Hangzhou Alltest Biotech Co Ltd (China)

374693

High sensitivity

19 January 2022

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,975kb)

Nasal swab

Orvato Healthcare Pty Ltd

Acon Biotech (Hangzhou) Co Ltd (China)

382250

Very high sensitivity

8 January 2022

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,613kb)

Nasal swab

Innovation Scientific Pty Ltd

Innovation Scientific Pty Ltd (Australia)

336146

Acceptable sensitivity

28 October 2021

Gardian T3 COVID-19-SARS-CoV-2 Antigen Saliva Self Test (pdf,691kb)

Saliva

Gardian Technologies Pty Ltd

Jiangsu Medomics Medical Technology Co Ltd (China)

384538

Very high sensitivity

22 February 2022

Gmate COVID-19 Ag Saliva (pdf,2.38Mb)

Saliva

MD Solutions Australasia Pty Ltd

Philosys Co Ltd (Korea - Republic of)

383823

Very high sensitivity

10 February 2022

JusChek SARS-CoV-2 Antigen Rapid Test (Nasal Swab) INCP-502H Self Test (pdf,166kb)

Nasal swab

Compliance Management Solutions

Hangzhou Alltest Biotech Co Ltd (China)

374574

High sensitivity

31 December 2021

JusChek COVID-19 Antigen Rapid Test (Oral Fluid) ICOV-802H Self Test (pdf,177kb)

Oral fluid

Compliance Management Solutions

Hangzhou Alltest Biotech Co Ltd (China)

374574

High sensitivity

31 December 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

Medriva COVID-19 Rapid Antigen Test (pdf,258kb)

Nasal swab

ProcureNet APAC Pty Ltd

Hangzhou Testsea Biotechnology Co Ltd (China)

383819

Very high sensitivity

10 February 2022

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

Novel coronavirus (SARS-Cov-2) Antigen Rapid tests device (nasal swab) (pdf,6.9Mb)

Nasal swab

Dexcon Pty Ltd

Hangzhou Realy Tech Co Ltd (China)

384660

Very high sensitivity

24 February 2022

Novel Coronavirus (SARS-COV-2) Antigen Rapid test cassette (swab) (pdf,617kb)

Nasal swab

Doncaster Australia Pty Ltd

Hangzhou Realy Tech Co Ltd (China)

382615

Very high sensitivity

25 February 2022

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) (pdf,482kb)

Nasal swab

Solasta Life Pty Ltd

Hangzhou Realy Tech Co Ltd (China)

334501

Very high sensitivity

23 February 2022

Nuex Medical COVID-19 Antigen Test Cassette (pdf,1.02Mb)

Nasal swab

Nuex Medical Melbourne

Hangzhou Testsea Biotechnology Co Ltd (China)

386305

Very high sensitivity

25 March 2022

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,163kb)

Saliva

Well Biotech Pty Ltd

Jiangsu Well Biotech Co Ltd (China)

377136

Very high sensitivity

29 October 2021

Orawell COVID-19 Ag Rapid Saliva Test Device (Self-test) (pdf,273kb)

Saliva

LRY Group of Companies Pty Ltd

Jiangsu Well Biotech Co Ltd (China)

385275

Very high sensitivity

8 March 2022

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

Rapid SARS-COV-2 Antigen Test Card Self-test (pdf,808kb)

Nasal swab

MP Biomedicals Australasia Pty Ltd

MP Biomedicals Asia Pacific Pte Ltd (Singapore)

373711

Very high sensitivity

30 December 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 Rapid Test (pdf, 5.27Mb)

Nasal swab

Alpha-Medics Australia Pty Ltd

Qingdao Hightop Biotech Co Ltd (China)

385179

Very high sensitivity

4 March 2022

SARS-CoV-2 Antigen Saliva Lolly Test (pdf, 2.98Mb)

Saliva

Alpha-Medics Australia Pty Ltd

Hangzhou Sejoy Electronics & Instruments Co Ltd (China)

386690

High sensitivity

4 April 2022

SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) (pdf,2Mb)

Nasal swab

VITRYL AUS PTY LTD

Labnovation Technologies Inc (China)

388031

Very high sensitivity

5 May 2022

SARS-CoV-2 Antigen Self Test Nasal (pdf,616kb)

Nasal swab

Roche Diagnostics Australia Pty Limited

SD Biosensor Inc (Korea - Republic of)

352250

Acceptable sensitivity

15 October 2021

SecurePlus COVID-19 Antigen Test Cassette (pdf,585kb)

Nasal swab

Plus Medical Pty Ltd

Hangzhou Testsea Biotechnology Co Ltd (China)

385550

Very high sensitivity

15 March 2022

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Assay Kit (pdf,506kb)

Nasal swab

Talbot Medical Pty Ltd

Maccura Biotechnology Co Ltd (China)

385370

Very high sensitivity

9 March 2022

Sonictec Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (pdf,879kb)

Nasal swab

Sonictec Pty Ltd

Hangzhou Realy Tech Co Ltd (China)

384537

Very high sensitivity

22 February 2022

SureScreen SARS-CoV-2 Antigen Rapid test Cassette (Nasal Swab) (Gold) (pdf 1.1Mb)

Nasal swab

SureScreen Australia Pty Limited

SureScreen Diagnostics Ltd (United Kingdom)

387662

Very high sensitivity

29 April 2022

SureScreen Diagnostics SARS-CoV-2 Antigen Rapid test Cassette (Nasal Swab) (Gold) with RhinoSwab Junior (pdf 1.29Mb)

Nasal swab

SureScreen Australia Pty Limited

SureScreen Diagnostics Ltd (United Kingdom)

387662

Very high sensitivity

29 April 2022

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

Nasal swab

Pharma Soul Pty Ltd

Hangzhou Testsea Biotechnology Co Ltd (China)

373151

Very high sensitivity

18 November 2021

Jamach COVID-19 Antigen Test Cassette (pdf,1.11Mb)

Nasal swab

Jamach Pty Ltd

Hangzhou Testsea Biotechnology Co Ltd (China)

385429

Very high sensitivity

10 March 2022

V-Chek COVID-19 Antigen Saliva Test (pdf,591kb)

Saliva

Cole Workwear PL

Guangzhou Decheng Biotechnology Co Ltd (China)

374065

Very high sensitivity

17 November 2021

VivaDiag Pro SARS-CoV-2 Ag Rapid Test (pdf,394kb)

Nasal swab

Stonestar Wholesale Pty Ltd

VivaChek Biotech (Hangzhou) Co Ltd (China)

348890

High sensitivity

25 February 2022

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (pdf,2031kb)

Nasal swab

Australia Biotech Pty Ltd

Guangzhou Wondfo Biotech Co Ltd (China)

385653

High sensitivity

15 March 2022