Australia's only approved at-home test for chlamydia and gonorrhoea has been suspended by the Therapeutic Goods Administration (TGA) after it failed to detect infections for an unspecified number of patients. The TGA review found the Touch Biotechnology test kit posed a high risk of false negative results.
Suspension and reliability concerns
The TGA handed Touch Biotechnology a six-month suspension, stating the device is not reliable. The regulator was alerted by a health service in May about false negative results affecting an unspecified number of patients, though the TGA could not reveal which service raised the concern. The TGA also said it does not have a reliable estimate of how many users may have received false negative results.
Product details and company response
The test, which retailed for around $24, involved a vaginal swab placed in a container with testing solution. It first appeared on pharmacy shelves in December 2024. Touch Biotechnology's general manager, Mazz Gencer, acknowledged the TGA's action and said the company has ceased supply pending further verification and performance testing.
At the time of approval, the company claimed the test correctly identified more than 99% of positive cases for both chlamydia and gonorrhoea when compared against urine PCR testing, with no false positives. However, the company declined to share evidence, stating it is not disclosing non-public regulatory submissions or technical information.
Expert warnings and implications
Sexual health experts had urged caution when the product was approved in late 2024. Dr Sara Whitburn, deputy medical director at Sexual Health Victoria, said the TGA's findings highlight the need for stronger evidence requirements and ongoing oversight of self-testing kits. She called for independent evidence, including peer-reviewed clinical data and real-world performance studies, before future approvals of similar products.
Whitburn warned that false negatives can have serious consequences, as chlamydia and gonorrhoea are often asymptomatic. Undetected infections can remain untreated and be passed to partners, leading to complications such as pelvic inflammatory disease, infertility, and ectopic pregnancy. She noted that at-home STI self-tests can play an important role in making testing more accessible but should not replace clinic-based care.
Recommendations for users
Whitburn advised that if anyone used this self-test and received a negative result, they should see a doctor or visit a sexual health clinic for further assessment and a laboratory test to confirm the result. She emphasized that a negative result does not always rule out an STI.
