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.
COVID-19 nucleic acid amplification self-tests (for home use) are also approved for supply in Australia. Nucleic acid amplification (NAA) tests detect the genetic material from the SARS-CoV-2 virus, rather than the spike protein detected by rapid antigen tests during active infection.
The TGA's performance requirements for COVID-19 self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO) and the European Commission. For rapid antigen tests, 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 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) (Rapid antigen test) |
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 1.3Mb) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
Nasal swab |
Nature's Family Australia Pty Ltd |
GenBody Inc (Korea - Republic of) |
383887 |
Acceptable sensitivity |
11 February 2022 |
|
EasyNAT COVID-19 RNA Test for Self-Testing (pdf,3.2Mb) (Nucleic acid test) |
Nasal swab |
Elamaan Health Pty Ltd |
Ustar Biotechnologies (Hangzhou) Ltd (China) |
390609 |
Very high sensitivity |
17 June 2022 |
|
Ecotest COVID-19 Antigen Nasal Test Self Test (pdf,451kb) (Rapid antigen test) |
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) (Rapid antigen test) |
Saliva |
Emergence Technology Pty Ltd |
Assure Tech (Hangzhou) Co Ltd (China) |
372335 |
Acceptable sensitivity |
22 October 2021 |
|
Fanttest: Covid-19/Influenza A&B Antigen Test Kit (pdf,2Mb) (Combination Rapid antigen self-test) |
Nasal swab |
Sonictec Pty Ltd |
Hangzhou Fanttest Biotech Co Ltd (China) |
395590 |
High sensitivity |
7 September 2022 |
|
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,422KB) (Rapid antigen test) |
Nasal swab |
AusDiagnostics Pty Ltd |
Acon Biotech (Hangzhou) Co Ltd (China) |
382031 |
Very high sensitivity |
6 January 2022 |
|
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,330kb) (Rapid antigen test) |
Nasal swab |
Medco Solutions Pty Ltd |
Acon Biotech (Hangzhou) Co Ltd (China) |
382250 |
Very high sensitivity |
8 January 2022 |
|
Gardian T3 COVID-19-SARS-CoV-2 Antigen Saliva Self Test (pdf,691kb) (Rapid antigen test) |
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) (Rapid antigen test) |
Saliva |
MD Solutions Australasia Pty Ltd |
Philosys Co Ltd (Korea - Republic of) |
383823 |
Very high sensitivity |
10 February 2022 |
|
GSD NovaGen SARS CoV-2 Ag Rapid Test (Nasal swab) Self-testing (pdf,297kb) (Rapid antigen test) |
Nasal swab |
Eurofins Technologies Australia Pty Ltd |
Hangzhou Alltest Biotech Co Ltd (China) |
374693 |
High sensitivity |
19 January 2022 |
|
Hough COVID-19 Home Test (pdf,3.48Mb) (Rapid antigen test) |
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) (Rapid antigen test) |
Nasal swab |
Innovation Scientific Pty Ltd |
Innovation Scientific Pty Ltd (Australia) |
336146 |
Acceptable sensitivity |
28 October 2021 |
|
JusChek SARS-CoV-2 Antigen Rapid Test (Nasal Swab) INCP-502H Self Test (pdf,166kb) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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,484kb) (Rapid antigen test) |
Nasal swab | Rapant Pty Ltd | Hangzhou Realy Tech Co Ltd (China) | 395414 | Very high sensitivity | 2 September 2022 |
|
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) (pdf,482kb) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
Nasal swab |
Abbott Rapid Diagnostics Pty Ltd |
Abbott Rapid Diagnostics Jena GmbH (Germany) |
345192 |
Very high sensitivity |
26 October 2021 |
|
Rapid Response COVID-19 Antigen Rapid Test Cassette - At Home (pdf,548kb) (Rapid antigen test) |
Nasal swab |
SureScreen Australia Pty Limited |
BTNX Inc |
347092 |
High sensitivity |
21 June 2022 |
|
Rapid SARS-COV-2 Antigen Test Card Self-test (with pre -filled buffer)(pdf,1.97Mb) (Rapid antigen test) |
Nasal swab |
MP Biomedicals Australasia Pty Ltd |
MP Biomedicals Asia Pacific Pte Ltd (Singapore) |
373711 |
Very high sensitivity |
16 August 2022 |
|
Rapid SARS-COV-2 Antigen Test Card Self-test (without pre- filled buffer) (pdf,808kb) (Rapid antigen test) |
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) (Rapid antigen test) |
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,616kb) (Rapid antigen test) |
Nasal swab |
Roche Diagnostics Australia Pty Limited |
SD Biosensor Inc (Korea - Republic of) |
352250 |
Acceptable sensitivity |
15 October 2021 |
|
SARS-CoV-2 Antigen Rapid Test (pdf,5.27Mb) (Rapid antigen test) |
Nasal swab |
Alpha-Medics Australia Pty Ltd |
Qingdao Hightop Biotech Co Ltd (China) |
385179 |
Very high sensitivity |
4 March 2022 |
|
SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) (pdf,2Mb) (Rapid antigen test) |
Nasal swab |
VITRYL AUS PTY LTD |
Labnovation Technologies Inc (China) |
388031 |
Very high sensitivity |
5 May 2022 |
|
SARS-CoV-2 Antigen Saliva Lolly Test (pdf,2.98Mb) (with software) (Rapid antigen test) |
Saliva |
Alpha-Medics Australia Pty Ltd |
Hangzhou Sejoy Electronics & Instruments Co Ltd (China) |
386690 |
High sensitivity |
4 April 2022 |
|
SARS-CoV-2 Antigen Saliva Lolly Test (pdf,394kb) (without software)(Rapid antigen test) |
Saliva |
Alpha-Medics Australia Pty Ltd |
Hangzhou Sejoy Electronics & Instruments Co Ltd (China) |
386690 |
High sensitivity |
28 June 2022 |
|
SARS-CoV-2 Antigen Test Kit (LFIA) (pdf,2Mb) (Rapid antigen test) |
Nasal swab |
Pale Blue Medical Trading Pty Ltd |
Jiangsu Medomics Medical Technology Co Ltd (China) |
380739 |
Very high sensitivity |
23 June 2022 |
|
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) – Self-test (pdf,447kb) (Rapid antigen test) |
Nasal swab |
BGI Health (AU) Company Pty Ltd |
BGI Europe A/S (Denmark) |
334043 |
Acceptable sensitivity |
20 June 2022 |
|
SecurePlus COVID-19 Antigen Test Cassette (pdf,585kb) (Rapid antigen test) |
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,890kb) (Rapid antigen test) |
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) (Rapid antigen test) |
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) (Rapid antigen test) |
Nasal swab |
SureScreen Australia Pty Limited |
SureScreen Diagnostics Ltd (United Kingdom) |
387662 |
Very high sensitivity |
29 April 2022 |
|
(Rapid antigen test) |
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) (Rapid antigen test) |
Nasal swab |
Pharma Soul Pty Ltd |
Hangzhou Testsea Biotechnology Co Ltd (China) |
373151 |
Very high sensitivity |
18 November 2021 |
|
TouchBio SARS-CoV-2 & FLU A/B Antigen Combo Test (nasal) (pdf,6.7Mb) (Combination Rapid antigen Self test) |
Nasal swab |
Touch Biotechnology Pty Ltd |
Vitrosens Biyoteknoloji LTD STI (Turkey) |
395591 |
Very high sensitivity |
7 September 2022 |
|
Jamach COVID-19 Antigen Test Cassette (pdf,1.09Mb) (Rapid antigen test) |
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) (Rapid antigen test) |
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,387kb) (Rapid antigen test) |
Nasal swab |
Stonestar Wholesale Pty Ltd |
VivaChek Biotech (Hangzhou) Co Ltd (China) |
348890 |
High sensitivity |
25 February 2022 |
|
WHISTLING TEST 2019-nCoV Saliva Ag EASY TEST (pdf,1.3Mb) (Rapid antigen test) |
Saliva |
Talbot Medical Pty Ltd |
Guangzhou Decheng Biotechnology Co Ltd (China) |
391125 |
High sensitivity |
22 June 2022 |
|
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (pdf,1.98Mb) (Rapid antigen test) |
Nasal swab |
Australia Biotech Pty Ltd |
Guangzhou Wondfo Biotech Co Ltd (China) |
385653 |
High sensitivity |
15 March 2022 |