TGA suspends chlamydia and gonorrhoea self-test over accuracy concerns

TGA suspends chlamydia and gonorrhoea self-test over accuracy concerns

15 Jul 2026

The decision follows a TGA review of the TouchBio Chlamydia and Gonorrhoea Test for Self-Testing (for females) to assess how accurately it detects infection.

Independent laboratory testing suggested that some people received negative results from the self-test despite later testing positive using other approved diagnostic methods.

The TGA said the device cannot currently be considered reliable for detecting Chlamydia trachomatis and Neisseria gonorrhoeae at the concentrations claimed by the manufacturer. It warned that false negative results could delay diagnosis and treatment and increase the risk of ongoing transmission.

As a result, the test has been suspended from the Australian Register of Therapeutic Goods (ARTG) and cannot be legally supplied in Australia while the suspension remains in place. The suspension is scheduled to continue until 17 December 2026.

The manufacturer is working to address the concerns by providing further evidence that the test can accurately detect both infections.

The TGA is advising healthcare professionals that a negative result from this self-test should not be used to rule out infection. People with symptoms, possible exposure or a higher risk of sexually transmitted infections should undergo appropriate clinical assessment and, where needed, confirmatory laboratory testing.

The self-test was introduced in 2024 as Australia's first rapid at-home test for chlamydia and gonorrhoea in women.

TGA suspends chlamydia and gonorrhoea self-test over accuracy concerns

 
Source: Therapeutic Goods Administration (TGA) | newsGP

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