With rates of some sexually transmitted infections in Australia on the rise, women will soon be able to test themselves for chlamydia and gonorrhoea at home – but sexual health experts have urged caution.
Australia’s drugs regulator, the Therapeutic Goods Administration (TGA), has approved the rapid home test for sale, and it is expected to be available in pharmacies from 13 December, with a recommended retail price of $24. The test involves taking a vaginal swab, which is then placed in a container with testing solution.
Dr Sara Whitburn, the deputy medical director at Sexual Health Victoria, said while greater access to testing is crucial for reducing transmission of sexually transmitted infections, and new initiatives to encourage testing are welcome, there are important caveats around the home test.
“It’s important to note that the test is validated only for vaginal samples, meaning it cannot be used to screen for oral or anal chlamydia and gonorrhoea,” she said.
The test developer, Touch Biotechnology, states that when the test was compared against urine PCR testing, it correctly identified more than 99% of positive cases for both chlamydia and gonorrhoea, and did not produce any false positives.
However, these results are based on the company’s own testing of 312 people, and the findings have not been published in a peer-reviewed medical journal.
“As a screening test, it is recommended that individuals consult a healthcare professional for a repeat PCR test to confirm a positive diagnosis,” Whitburn said.
“This reliance on follow-up testing may inadvertently delay diagnosis and treatment, especially if individuals do not seek a health professional assessment.”
She said people who seek testing for sexually transmitted disease at a sexual health or GP clinic are more likely to be offered comprehensive asymptomatic screening, which would typically include tests for HIV and syphilis.
The Royal College of Pathologists (RCPA) issued a warning in July of a concerning rise in cases of gonorrhoea, syphilis and HIV nationally.
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As part of the conditions of approval, the TGA has stated Touch Biotechnology must maintain a post-market surveillance report, including information on any adverse events, including numbers of any reported false positive or false negative results.
Whitburn said people with genital or pelvic symptoms may feel a sense of false reassurance with a negative result from a home chlamydia and gonorrhoea test, which “does not allow for a complete history and examination”.
Symptoms could be related to another infection, or a condition such as candidiasis, bacterial vaginosis, a dermatological condition, or a urinary tract infection, she said, all of which require medical professionals to diagnose and treat.
Touch Biotechnology CEO, Matt Salihi, said comprehensive STI screening and follow-up care are best managed by a healthcare provider, but said he hopes the test will help those wanting a fast result and who may find going to a GP too expensive.