Australian Regulatory Agency Issues Guidance for Manufacturers of COVID-19 Self-Tests

Australia’s Therapeutic Goods Administration (TGA) has issued guidance for manufacturers of COVID-19 rapid antigen self-tests, including required instructions for use.

The tests “should clearly describe the environmental conditions, incubation times, time between sampling and reading, and correct interpretation of positive and negative results illustrated so that a lay person can easily understand,” the agency said.

The TGA also said the instructions “must be usable by individuals of different literacy levels and in multiple languages.”