The TGA green light will see it available to buy in the next few weeks.
A rapid self-test for chlamydia and gonorrhea for women has been approved by the TGA, making it available to buy in the next few weeks.
The test involves taking one swab and provides results for both infections in 15 minutes.
Rates of chlamydia have increased 26% in the last decade and gonorrhoea has climbed 157%.
The former is the most reported communicable disease in Australia, but is often asymptomatic, the manufacturer of the test, Australian company Touch Biotechnology, said in a press release.
In addition, people often did not test because of perceived stigma or because they were not aware of the need to, they said.
“For women in particular, STIs such as gonorrhoea and chlamydia are major causes of pelvic inflammatory disease and infertility if they go undiagnosed and untreated,” general manager Mazz Gencer said.
“These infections can also cause complications to pregnancy and birth because of the risk of mother-to-child transmission. That’s why it’s incredibly important for women to test for STIs when experiencing even the smallest of symptoms or are concerned about a partner’s sexual activity.”
Prior to the availability of this test, women had to complete an invasive lab or PCR test, which was more expensive and took one to three days to report results, the company said.
“The introduction of the first rapid self-test kit for chlamydia and gonorrhoea will aid in the prevention of STIs because with increased access to accurate, private testing, we hope it will empower women to take the first step towards receiving a diagnosis,” said CEO Matt Salihi.
The test is performed at home and is similar to other RAT tests. A swab is taken from 1-1.5cm inside the vaginal canal. The swab is submerged in a buffer tube, and a solution is added. The buffer sample is then added to the appropriate location on the cassette, and the results are read after 15 minutes.
“While this self-test can aid early detection, comprehensive STI screening and follow-up care are best managed in consultation with a healthcare provider,” the manufacturer said.
