15 October 2021 | News
COVID-19 self-tests (home use) approved by TGA
Image credit: Hangzhou Alltest Biotech
The Therapeutic Goods Administration (TGA), the medicine and therapeutic regulatory agency of the Australian Government, has approved two COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021.
Both tests have been manufactured by Chinese firm Hangzhou Alltest Biotech, and will be supplied within Australia by AM Diagnostics.
The All Test COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARSCoV-2 Antigens in human oral fluid specimen.
The All Test SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in human swab specimen.
These tests are intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).