A tampon is being repurposed to screen for sexually transmitted infections, with the at-home test aiming to encourage more women to seek treatment.
The gynaecological health startup Daye has launched an STI diagnostic tampon, which uses a polymerase chain reaction (PCR) test to check for chlamydia, gonorrhoea, trichomonas, mycoplasma and ureaplasma, with the tampon used in place of a swab or speculum.
The aim of the screening kit is to speed up diagnosis and treatment, particularly among patient groups who are anxious or embarrassed about getting a test, Daye said.
Growing numbers of people are experiencing sexually transmitted infections, with a 24% increase in 2022 compared with 2021, according to the UK Health Security Agency. Women are also statistically more at risk than men due to the vaginal physiology.
Michelle Tempest, a lecturer in medical law and ethics at Cambridge University’s medical school, said Daye was “redefining” STI testing, allowing women to take control of their sexual health “in a noninvasive way in the comfort of their own homes”.
The tampon is sent to a lab for testing, and results are returned within five working days. The applicator allows the user to reach their cervix without a speculum.
Dr Amira Bhaiji, a trainee physician for the NHS, said it was the perfect solution “for increased uptake and accuracy of STI testing”. She said it would give “the user their ownership back, which historically has been known to be quite a lonely and very personal struggle for some to overcome”.
She added: “Furthermore, the method of collection opens up a whole new realm of possibility of vaginal microbiome research, and in such a user-friendly form … encourages more people to come forward and participate, and that opens the door to an entirety of neglected research.”
However, the epidemiologist Emma Harding-Esch, associate professor at the London School of Hygiene & Tropical Medicine, expressed caution on some forms of at-home testing. She said the British Association for Sexual Health and HIV (Bashh) considers testing for organisms of doubtful clinical significance, such as ureaplasma – a form of bacteria that is often found in the urinary or genital tract and can be transmitted through sexual contact – among others, inappropriate, as it could lead to overtreatment.
Harding-Esch said: “Although research has been published in the peer-reviewed literature indicating that tampons could be used as the sample type for diagnosing STIs, the recommended sample types for Mycoplasma genitalium and Trichomonas vaginalis, when they are indicated, and for Chlamydia trachomatis and Neisseria gonorrhoeae, are swabs and urine only in men.”
The launch of the tampon follows clinical trials with 600 patients.
Valentina Milanova, the founder of Daye, said: “We’ve gathered a significant amount of data from our diagnostic tampon over the past few months. We observed a 1% test failure rate due to insufficient sample collection, compared with the 10% and more recorded with the swab. We are also able to reduce sample collection errors significantly, making this an ideal approach for at-home sample collection as part of our strategic initiative to reduce patient wait times and improve access to care.
“We are mindful of the concerns related to overtreatment and antibiotic resistance. That’s why our clinical protocols include education about restoring a healthy vaginal microbiome as the first key measure to reducing ureaplasma and mycoplasma loads. Studies show that under healthy vaginal microbiome conditions and the absence of BV [bacterial vaginosis]-related bacteria, ureaplasma … can reduce on its own. Treatment is only recommended in the presence of high bacterial load and absence of other infections or history of unexplained recurrent pregnancy loss.”
