The TGA has suspended the registration of Australia’s only self-test for gonorrhoea and chlamydia after independent testing raised concerns about false negatives.

The TGA said it was aware of patients who had received a negative result using the TouchBio chlamydia and gonorrhoea self-test, which relies on self-collected vaginal swabs, but had subsequently tested positive using other methods.

It said it had also commissioned independent lab testing to verify the accuracy of the $24 device, which had not been able to reproduce its claimed detection rate for either chlamydia or gonorrhoea.

It suspended the device from the Australian Register of Therapeutic Goods on 17 June.