Australian-first STI self-test receives TGA approval

A first of its kind in Australia, the approval of a rapid self-test kit has been hailed by one GP expert as an ‘important step forward’ in the prevention of sexually transmitted infections (STIs) for women.
 
Developed by Touch Biotechnology, the test is able to detect chlamydia and gonorrhoea – two of the most common STIs in Australia – with one swab sample, producing a result in 15 minutes.
 
Both STIs are a particular concern for women, as if left undiagnosed and untreated can have ramifications, including pelvic inflammatory disease and scarring in the fallopian tubes, resulting in a greater risk of pregnancy complications, and in some cases infertility.
 
The developers say their hope is that availability of self-testing kits will lead to increased testing, by giving patients more privacy, and result in earlier diagnosis.
 
Dr Sara Whitburn, Chair of RACGP Specific Interests Sexual Health Medicine, believes the new kit will provide ‘improved access’ to STI screening.
 
‘Enhanced access to testing and subsequent treatment for positive results is crucial for reducing the transmission of STIs, so new initiatives to encourage testing are welcome,’ she told newsGP.
 
‘Additionally, the kit’s product information indicates it has high sensitivity and specificity for detecting chlamydia and gonorrhoea, and there is no interference of the test with common vaginal topical treatments or no cross-reactivity with normal vaginal flora or other STIs such as HPV, HSV or syphilis.’
 
The Victorian-based GP however did note the test is validated only for vaginal samples, meaning it cannot be used to screen for oral or anal chlamydia and gonorrhoea.
 
But Dr Whitburn said there are some potential drawbacks to the new approach.
 
‘As a screening test, it is recommended that individuals consult a healthcare professional for a repeat PCR test to confirm a positive diagnosis,’ she said.
 
‘This reliance on follow-up testing may inadvertently delay diagnosis and treatment, especially if individuals do not seek a health assessment.’
 
newsGP reported a surge in STI cases post-pandemic, with cases of gonorrhoea rising by 45% and chlamydia by 24% from 2021–23, with people aged 15–29 making up the majority of cases.
 
Chlamydia, which is the most reported communicable disease in Australia, often presents as asymptomatic. Meanwhile lack of awareness, further compounded by a perceived stigma, can result in a reluctance to test.
 
On the other hand, while gonorrhoea is symptomatic, often presenting with unusual discharge, pain or bleeding, it can be mistaken for other infections as symptoms may not present until months later.
 
Up until now, testing for the STIs needed to be formally conducted through a healthcare service, with individual lab or PCR testing, and results taking between 1–3 days to receive.
 
Professor Mark Morgan, Chair of RACGP Expert Committee – Quality Care, agrees there are a number of positives to the new test kit, however, he says more information about the formulation of the test is needed.
 
‘It will be important to understand the accuracy of these tests in the real world where user error and improper storage of testing kits might be factors,’ he told newsGP.
 
Beyond that however, Professor Morgan is concerned that self-testing will remove the opportunity for GPs to talk about sexual health with the patient more broadly.
 
‘GPs will often use appointments about possible STIs to enquire about contraception, talk about safe-sex, and identify the risk of domestic violence,’ he said.
 
‘Contact tracing is [also] an important follow up for positive results, otherwise the cycle of infection can continue.’
 
Dr Whitburn expressed similar concerns, noting that the kit does not facilitate a more comprehensive asymptomatic screening, which would typically include tests for HIV and syphilis.
 
‘For individuals presenting with genital or pelvic symptoms, the kit may provide false reassurance that these symptoms are not due to chlamydia or gonorrhoea,’ she said.
 
‘It does not allow for a complete history and examination, which are necessary to diagnose and treat the underlying causes of these symptoms, as they could be related to another STI or a non-STI condition such as candidiasis, bacterial vaginosis, a dermatological condition, or a urinary tract infection.’
 
Meanwhile, by placing access to testing in the pharmacy setting, Professor Morgan fears it could eventually see patients accessing treatment through a future iteration of pharmacy prescribing.
 
‘This would represent a further lost opportunity for holistic care,’ he said.
 
The test, which received TGA approval on 11 November, is expected to be available for purchase through pharmacies, distributors and online as early as next month.
 
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