The regulator warns clinicians that false negatives from an at-home chlamydia and gonorrhoea test could delay diagnosis and fuel ongoing transmission.
Australia’s medicines regulator has warned healthcare professionals not to rely on results from a commercially available chlamydia and gonorrhoea self-test after a review found it could fail to detect infections at the concentrations claimed by the manufacturer.
The findings have raised concerns about false negative results and prompted suspension of the product from the Australian Register of Therapeutic Goods (ARTG).
“While the suspension is in place, the device cannot be lawfully supplied by the sponsor in Australia,” the Therapeutic Goods Administration (TGA) said in a statement.
According to the Australian Centre for Disease Control’s National Notifiable Disease Surveillance System, there have been 49,342 confirmed notifications of chlamydia in Australia this year, and 23,900 notifications of gonorrhoea (as of 16 July).
The TGA issued the safety alert after completing a review of the TouchBio Chlamydia & Gonorrhoea Test for self-testing (for females), concluding it was unable to reproduce the manufacturer’s analytical performance claims for limit of detection.
According to the regulator, the device could not be shown to reliably detect Chlamydia trachomatis and Neisseria gonorrhoeae at the claimed concentrations, creating a risk of false negative results.
“False negative results may lead to missed detection of infection, delays in diagnosis and treatment, and ongoing transmission,” the TGA said.
Healthcare professionals have been advised to consider appropriate follow-up and confirmatory testing in line with local clinical practice, particularly for patients at increased risk of sexually transmitted infections, regardless of a negative result obtained with the affected self-test.
“Based on the above findings, a negative result from the device does not exclude infection. The device should not replace assessment by a medical practitioner and is best considered as an initial screening tool,” the TGA said.
The regulator stressed the alert related specifically to the TouchBio self-test and did not affect laboratory-based nucleic acid amplification testing, which remains the recommended diagnostic standard for chlamydia and gonorrhoea.
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The device was Australia’s first approved rapid self-test for chlamydia and gonorrhoea in women and other people with a vagina, receiving TGA approval in late 2024 as part of efforts to improve access to STI screening.
At the time, self-testing was viewed as a way to reduce barriers to testing, particularly for people reluctant or unable to attend healthcare services.
Following its review, the TGA suspended the product from the ARTG under section 41GA(1)(a) of the Therapeutic Goods Act, citing a potential risk of death, serious illness, or serious injury if the device remained available.
The suspension took effect on 17 June and will remain in place until 17 December unless revoked earlier.
The sponsor, Touch Biotechnology Pty Ltd, is undertaking additional work to address the issues identified by the regulator, including demonstrating that the test could reliably detect both organisms at the claimed concentrations.
The TGA has advised consumers who have used the test and continue to have symptoms, believe they may have been exposed to an STI, or remain concerned despite a negative result to seek medical assessment and laboratory testing.
Positive self-test results should also be confirmed through standard pathology testing before treatment decisions are made, the regulator said.
