Australians who relied on an at-home STI test may have been left in the dark about their infections. The country's sole approved self-testing kit for chlamydia and gonorrhoea has been withdrawn from sale after a regulatory review found it to be unreliable. According to the Therapeutic Goods Administration (TGA), the product posed a significant risk of false negative results, which can have serious consequences.
The TGA's decision follows an alert in May from a health service about incorrect test results affecting an unknown number of patients. While the exact scale of the issue is unclear, regulators are concerned that many users may have received inaccurate results without knowing it. The at-home kit involved a vaginal swab and testing solution and was available in pharmacies for around £12.70 (A$24). It's worth noting that this product had initially been touted as effective in identifying over 99% of positive cases, but experts had raised concerns from the start.
Touch Biotechnology has confirmed it has stopped supplying the tests while further verification and performance testing take place. When first approved in late 2024, the company claimed its product produced no false positives, but this latest finding highlights the need for stricter evidence requirements and ongoing oversight of self-testing kits. Dr Sara Whitburn, Deputy Medical Director at Sexual Health Victoria, has called for stronger independent evidence before similar products receive approval.
False negative results can have serious consequences as these STIs often go undetected until complications arise. Untreated infections can be transmitted to partners and lead to severe health issues such as pelvic inflammatory disease, infertility, and ectopic pregnancy. While at-home tests aim to improve accessibility, experts stress that they should not replace professional clinic-based care and a negative result should always be confirmed by a doctor if concerns persist.