Australia's only approved at-home test for chlamydia and gonorrhoea has been yanked from pharmacy shelves after it turned out to be rather bad at telling people whether they have chlamydia or gonorrhoea. The Therapeutic Goods Administration (TGA) slapped Touch Biotechnology with a six-month suspension after a review found the $24 kit poses a 'high risk for false negative results' - which is medicalese for 'you might have an infection and not know it, congratulations.'

The test, which involves a vaginal swab and a container of testing solution, first hit shelves in December 2024. Touch Biotechnology had claimed it correctly identified more than 99% of positive cases for both infections when compared to urine PCR testing, with zero false positives. But the TGA was tipped off in May by a health service that reported false negatives affecting an unspecified number of patients. The regulator admitted it has 'no reliable estimate' of how many people received erroneous all-clears.

Touch Biotechnology's general manager, Mazz Gencer, said the company 'acknowledges the TGA’s action and has ceased supply' while it conducts further verification. The company declined to share any evidence of its test's performance, citing the confidentiality of 'non-public regulatory submissions.' It also refused to provide post-market surveillance reports - which, coincidentally, the TGA had required as a condition of approval two years ago.

Sexual health experts, who urged caution when the test was approved, are now feeling vindicated. 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 warned that false negatives can lead to untreated infections, which can cause pelvic inflammatory disease, infertility, and ectopic pregnancy. 'A negative result doesn’t always rule out an STI,' she said - a sentiment that probably should have been on the box.

Whitburn emphasized that at-home tests can be useful but 'shouldn’t replace clinic-based care.' For anyone who used the test and got a negative result, her advice is simple: see a doctor and get a lab test to confirm. In other words, the $24 test may have saved you a trip to the clinic, but now you get to go anyway - just with a little more anxiety.