Following FDA approval of first home-use HIV test, the TGA is reminding that Australian legislation prevents approval for distribution in Australia of similar home-use IVDs
. This legislation doesn't prevent ordering such products over the Internet (from overseas), for personal use.
The TGA may be happy to approve such IVD's for Point of Care use, though.
The whole story: http://www.tga.gov.au/consumers/information-devices-hiv-rapid-tests.htm
IMO, generally the positive impact of home-use HIV test on identifying unaware carriers and thus assisting hedging, outweighs the risks associated with lack of built-in pre- and post-test consultation and/or false results (the latter being validated to be rather low in the first place, in approved devices). Any approval process includes a risk management review where this balance could be evaluated on an individual device basis.
The TGA may be happy to approve such IVD's for Point of Care use, though.
The whole story: http://www.tga.gov.au/consumers/information-devices-hiv-rapid-tests.htm
IMO, generally the positive impact of home-use HIV test on identifying unaware carriers and thus assisting hedging, outweighs the risks associated with lack of built-in pre- and post-test consultation and/or false results (the latter being validated to be rather low in the first place, in approved devices). Any approval process includes a risk management review where this balance could be evaluated on an individual device basis.