TGA suspends chlamydia and gonorrhoea self test

The Therapeutic Goods Administration (TGA) has suspended Australia’s only self-test for chlamydia and gonorrhoea following concerns over false negative results.
 
It comes after the medicines watchdog undertook a review of TouchBio’s chlamydia and gonorrhoea test for self‑testing (for females) to verify its performance.
 
Its independent laboratory tests revealed suggestions of false negative results in individuals who had used the device, despite subsequent testing using other methods identifying infection.
 
‘Until this issue is resolved with the manufacturer, we consider the device is not reliable for detecting chlamydia trachomatis and neisseria gonorrhoeae at the claimed concentrations,’ the TGA said.
 
‘False negative results may lead to missed detection of infection, delays in diagnosis and treatment, and ongoing transmission.’
 
Following the review, the self-test was suspended from the Australian Register of Therapeutic Goods and, while the suspension is in place, cannot be lawfully supplied by the sponsor in Australia. 
 
The suspension is in place until 17 December 2026.
 
In response, the sponsor is undertaking further work to address the issues identified, including demonstrating that the device can reliably detect the conditions at the claimed concentrations.
 
The TGA is now urging healthcare professionals to be aware of the potential for false negative results associated with this device.
 
‘Based on the above findings, a negative result from the device does not exclude infection,’ it said.
 
‘The device should not replace assessment by a medical practitioner and is best considered as an initial screening tool. 
 
‘Where relevant, consideration may be given to appropriate follow‑up and confirmatory testing in line with local clinical practice, particularly in individuals at risk of infection.’
 
A first of its kind in Australia, the rapid self-test kit rolled out in 2024, and at the time, was labelled an ‘important step forward’ in the prevention of sexually transmitted infections for women.
 
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chlamydia gonorrhoea TGA Therapeutic Goods Administration