Rapid Antigen Test Information - TGA Data + Extended Shelf Life
The TGA has approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021.
Some, but not all manufacturers of approved rapid antigen tests (RATs) have extended the shelf-life of their products. We will update the table below as we receive further information on the extended shelf-life from the sponsor.
| Name of the self test / link to instructions | Sample type used | Australian Sponsor ( Supplier) | Manufacturer | ARTG | Clinical Sensitivity | Date Approved | Shelf Life |
|
CLUNGENE COVID-19 Antigen Rapid Test (For self-testing) (pdf,843kb) (Rapid antigen test) |
Nasal swab | Fortun8 International Trading Co Pty Limited | Hangzhou Clongene Biotech Co Ltd (China) | 396675 | Very high sensitivity | 29 September 2022 | 15 Months |
|
Clungene Covid-19 Antigen Rapid Test for self-testing (pdf,481kb) (Rapid antigen test) |
Nasal swab | APAC Security Pty Ltd | Hangzhou Clongene Biotech Co Ltd (China) | 333341 | Very high sensitivity | 7 January 2022 | 24 Months (extended) |
| TouchBio RSV, FLU A/B & Covid-19 Rapid Antigen Combo Test (Nasal) For Self-Testing | Nasal swab | Touch Biotechnology Pty Ltd | Vitrosens Biyoteknoloji LTD STI (Turkey) | 408459 | Very high sensitivity | 04 May 2023 | 24 Months |
| TouchBio SARS-CoV-2 & FLU A/B Antigen Combo Test (nasal) (pdf,6.72Mb) | Nasal swab | Touch Biotechnology Pty Ltd | Vitrosens Biyoteknoloji LTD STI (Turkey) | 395591 | Very high sensitivity | 07 September 2022 | 24 Months (extended) |
| Fanttest: Covid-19/Influenza A&B Antigen Test Kit (pdf,2Mb) | Nasal swab | Sonictec Pty Ltd | Hangzhou Fanttest Biotech Co Ltd (China) | 395590 | High sensitivity | 07 September 2022 | 24 Months (extended) |
|
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 | 21 Months (extended) |
|
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 | 30 Months (extended) |