Why did we contact them?

We spoke with Prof. Dr. med. Betschart, senior physician and deputy director at the University Hospital Zurich (USZ), to:

  • Gain insights into STI testing from a gynecological and clinical perspective
  • Validate and refine our approach for developing a self-test
Image of Prof. Dr. med. Cornelia Betschart
Prof. Dr. med. Betschart

Discussion

Current Solutions

She explained that STI diagnoses mainly arise in three contexts

  1. Patients with clinical symptoms
  2. Patients with a suspected infection
  3. Cases following sexual assault

The PCR results are typically available within 48 hours, after which patients receive treatment. Some infections (e.g. chlamydia, gonorrhoea) require follow-up testing six weeks later. Certain infections are notifiable and must be reported to the Swiss Federal Office of Public Health (BAG). She emphasized that STI screening currently plays only a minor role, primarily in pregnancy checks or infertility workups.

Barriers to Testing

She highlighted two barriers that prevent people from getting tested: the effort it takes to arrange and undergo testing, and the financial burden, since patients must often cover costs within their deductible under the Swiss system.

Choice of sample

She emphasized that different STIs require different sampling methods. Syphilis testing, for example, always requires a blood sample. For urine-based testing, she explained that the first morning urine is preferred, as it offers the best detection rate. Depending on a person’s sexual practices and possible sites of exposure, additional swabs may be necessary; she underlined the importance of testing at the right place.

However, she mentioned that in men, urethral swabs can be uncomfortable and urine samples often prove to be a viable alternative. For example, Chlamydia and gonorrhea can be detected quite reliably in urine, making this approach practical. Trichomonas, however, is different: while urine testing may work in some cases, it is not sufficiently reliable, especially in women, and therefore requires other methods.

Opinion on Self test

She regarded the concept of an STI self-test as promising, pointing to the success of COVID-19 self-tests and HPV self-sampling programs in other countries. However, she stressed that instructions must be clear about what to do after a positive result, including how urgent (or not) the situation is. At the same time, she warned against the risk of false reassurance if people test too soon after a high-risk encounter.

She noted that it could also be interesting as a point of care device, however, the value of the test would depend heavily on its reliability; if the sensitivity and specificity are comparable to PCR, then receiving results quickly would be highly beneficial.

She also asked about our distribution strategy and highlighted the importance of having an online presence, since many people first turn to Google when they suspect an infection.

Finally, she also emphasized the importance of discussing the project early with SwissMedic, to understand their position on self-tests and clarify what regulatory requirements might apply.

Communicating results

Prof. Dr. med. Betschart emphasized that the way results are communicated is critical, as people react very differently to a positive test. While some remain calm, others experience considerable anxiety or distress. She stressed the importance of ensuring that users immediately know where to turn for help. To address this, she recommended providing direct access to support, by providing clear guidance, ideally through a 24/7 hotline, so that no one is left alone with potentially overwhelming news. The emotional impact also depends on the infection: HIV has long carried a lot of weight, whereas chlamydia is often asymptomatic and generally perceived as less alarming. Professional follow-up is therefore indispensable—not only to confirm the result, but also to reassure patients and guide them through the appropriate next steps.

Clinical validation and regulation

She explained that once a prototype is ready, the first step would be to decide in which canton the study should take place, since regulations vary regionally. The project would then have to be submitted to an ethics committee (KEK), complete with formal procedures such as informed consent. She stressed that such a study would not only fulfill regulatory requirements but also provide valuable insights into how patients use the test, how it is accepted, and what behaviors it might influence.

Main Takeaways

STI screening currently plays only a marginal role in clinical settings, but the discussion showed that there is a clear demand for more accessible approaches. A reliable self-test could fill this gap, provided that it is clinically sound and supported with clear guidance for users.

Key insights included

  • Sample choice matters: urine is simple and practical, but additional blood or swab samples may be required for specific pathogens.
  • Self-testing is feasible and could build on the success of COVID-19 and HPV self-tests, but reliability and proper instructions are critical.
  • Patient support is essential: Positive results can trigger different emotional responses, so immediate access to guidance, ideally via a 24/7 hotline, and professional follow-up are crucial.
  • Negative results may give false reassurance if testing is done too early.
  • Regulatory and clinical validation: Close engagement with SwissMedic and ethics committees is necessary to ensure safety, compliance, and usability.

Integration

Based on our discussion with Prof. Dr. med. Betschart, we identified several areas where our STI self-test could be improved to better align with clinical practice, ensure user safety, and increase reliability. The following summarizes the specific changes and considerations we implemented in response to her input.

  • We updated our vision to include multiple sample types. In addition to urine samples, we now considered swabs (pharyngeal, anal, and cervical) to increase detection coverage as well as blood sampling for syphilis detection.
  • Self-testing feasibility: Designed clear, user-friendly instructions for sample collection and handling.
  • Patient support: Planned guidance on next steps for positive or negative results, emphasizing the importance of professional follow-up.
  • Timing and accuracy: Explained the limitations of early testing and the risk of false negatives in user instructions.
  • Regulatory and clinical validation: Engagement with Swissmedic to clarify regulatory requirements.
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