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COVID-19 rapid antigen self-tests that are approved in Australia
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14 April 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 |
|
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 |
| 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 |
|
Nasal swab |
Nature's Family Australia Pty Ltd |
GenBody Inc (Korea - Republic of) |
383887 |
Acceptable sensitivity |
11 February 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 |
| 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 |
|
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 |
|
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 |
| Nasal swab |
Nuex Medical Melbourne |
Hangzhou Testsea Biotechnology Co Ltd (China) |
386305 |
Very high sensitivity |
25 March 2022 |
|
| 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 |
| Nasal swab |
Abbott Rapid Diagnostics Pty Ltd |
Abbott Rapid Diagnostics Jena GmbH (Germany) |
345192 |
Very high sensitivity |
26 October 2021 |
|
| 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 |
| Nasal swab |
Alpha-Medics Australia Pty Ltd |
Qingdao Hightop Biotech Co Ltd (China) |
385179 |
Very high sensitivity |
4 March 2022 |
|
| Saliva |
Alpha-Medics Australia Pty Ltd |
Hangzhou Sejoy Electronics & Instruments Co Ltd (China) |
386690 |
High sensitivity |
4 April 2022 |
|
| Nasal swab |
Roche Diagnostics Australia Pty Limited |
SD Biosensor Inc (Korea - Republic of) |
352250 |
Acceptable sensitivity |
15 October 2021 |
|
|
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 |
| Nasal swab |
Pharma Soul Pty Ltd |
Hangzhou Testsea Biotechnology Co Ltd (China) |
373151 |
Very high sensitivity |
18 November 2021 |
|
| Nasal swab |
Jamach Pty Ltd |
Hangzhou Testsea Biotechnology Co Ltd (China) |
385429 |
Very high sensitivity |
10 March 2022 |
|
| Saliva |
Cole Workwear PL |
Guangzhou Decheng Biotechnology Co Ltd (China) |
374065 |
Very high sensitivity |
17 November 2021 |
|
|
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 |