With rates of some sexually transmitted infections on the rise in Australia, women will soon be able to test themselves for chlamydia and gonorrhea at home – but sexual health experts have urged caution.
Australia’s drug regulator, the Therapeutic Goods Administration (TGA), approved the quick home test for sale, and it is expected to be available in pharmacies starting December 13, with a suggested retail price of $24. The test involves taking a vaginal swab, which is then placed in a container with test solution.
Dr Sara Whitburn, the deputy medical director at Sexual Health Victoria, said that while greater access to testing is essential to reduce the transmission of sexually transmitted infections, and new initiatives to encourage testing are welcome, there are important caveats around home testing.
“It’s important to note that the test is only validated for vaginal samples, which means it can’t be used to screen for oral or anal chlamydia and gonorrhea,” she said.
The test developer, Touch Biotechnology, says that when the test was compared urine PCR test, it correctly identified more than 99% of positive cases for both chlamydia and gonorrhea, and produced no 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 can inadvertently delay diagnosis and treatment, especially if individuals do not seek a health professional assessment.”
She said that people who seek STD testing at a sexual health or GP clinic are more likely to be offered comprehensive asymptomatic screening, which will typically include testing for HIV and syphilis.
The Royal College of Pathologists (RCPA) issued a warning in July of an alarming increase in cases of gonorrhea, syphilis and HIV nationally.
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As part of the approval conditions, the TGA said that Touch Biotechnology must maintain a post-market surveillance report, including information on any adverse events, including the numbers of any reported false positive or false negative results.
Whitburn said people with genital or pelvic symptoms can feel a sense of false reassurance with a negative result from a home test for chlamydia and gonorrhea, which “does not allow for a complete history and examination.”
Symptoms may 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 is best managed by a health care provider, but said he hopes the test will help those who want a quick result and who may find going to a family doctor too expensive.
