Ann: TGA Registration Update, page-478

Reported by the Guardian

The federal government has quietly agreed to allow the importation of unapproved rapid antigen tests for personal use amid shortages of approved kits.Even the kits approved by the Therapeutic Goods Administration have varying degrees of accuracy, and the TGA is currently reviewing the effectiveness of the 23 tests approved for detecting Omicron. Low sensitivity on tests could mean people receive negative results even though they are infectious, and go on to spread the virus.The agriculture, water and the environment department’s website was updated on 12 January with new rules for imported tests. Up to three months’ supply of the unapproved tests can be brought into the country as long as they meet various conditions including “does not contain bee pollen”, and are commercially prepared and packaged for testing humans.

How can they not approve ours?