Enabling and translating advances in diagnostic and communication technologies to reduce the burden of STIs

Sexually transmitted infections (STIs) are a serious health problem in the UK, particularly in young people and the Government have made tackling them an urgent priority. STIs are also becoming increasingly resistant to antibiotics, making treatment much more difficult. Untreated STIs cause serious long term consequences to those affected, such as reduced fertility. One way of improving the situation would be to use better tests that diagnose individuals in clinic, with results in 20 minutes or so, as opposed to sending samples away and waiting a few days. This allows doctors to provide immediate treatment, advice and to get patients to tell their sexual partners to get checked and treated. All this reduces the chances of spreading infection. This new consortium called eSTI2, (electronic self-testing instruments for sexually transmitted infections) aims to bring together recent scientific developments in micro-engineering, molecular biology and telecommunications, working in partnership with biotech companies to help develop new types of rapid tests for STIs. The tests could, for example, allow people to use them like a pregnancy test - ?a self-test? - and link their results to their mobile phones (safely and securely) and then electronically to clinics, so individuals can get treated quickly. This might also allow public health doctors to get a better measure of how much infection exists in the population. An important part of eSTI2 scientists? work will be to turn ?gene chips? in micro-devices (their own and those of biotech companies) into a single test that can detect many different STIs at once. eSTI2 also aims to support getting the best tests introduced into the NHS as quickly as possible. eSTI2 will set up networks of STI clinics and microbiology labs across the UK, to test how well the devices work with real life patients and get the devices properly approved. It will consult a range of people all likely to be affected by the tests, for example patients and doctors, about the best way to use them. It will also try to find the best way to combine the use of mobile phones and rapid STI tests in the community, most effectively.

eSTI2 (electronic self testing instruments for sexually transmitted infections) is a multi-disciplinary consortium that aims to reduce the burden of STIs by building translational capacity to develop, improve, evaluate, adopt and facilitate the use of simple to use, rapid, accurate, polymicrobial and affordable point-of-care (PoC) and self-test mobile-phone networked micro-diagnostics. These ?eSTI2 technologies? will provide high-risk populations with easy and immediate access to STI diagnosis and treatment and make STI surveillance comprehensive and responsive. Implementation is currently hindered by: technological bottlenecks; lack of capacity to translate advances into validated commercial products; absence of single tests for multiple STI organisms; and little knowledge about the regulatory constraints, ethical challenges and health impacts of using telecommunications to personalise STI diagnosis and management. eSTI2 uniquely combines academic and industrial expertise to address these challenges through cross-disciplinary translational research and by creating trials capacity. There are 5 workstreams:
1. Translational microbiology: provides pathogen genomics and microarray expertise to evaluate DNA reporters for detecting multiple STI pathogens and antibiotic resistance markers and to incorporate these onto varied biosensor devices, with industry partners to deliver prototype PoC devices for clinical evaluation.
2. Microfluidics: will research barriers to developing microsystems and evaluate prototype devices for genital sample processing as a ?front-end? system for novel bio-sensing technologies.
3. Diagnostic Evaluation: will link the HPA?s network of GUM clinics and associated local microbiological laboratories in England, used for surveillance of HIV/STIs (GUMNet), directly to central microbiology laboratories to create sustainable capacity for clinical trials of novel diagnostics.
4. Public health impact of diagnostic interventions: will extensively assess the regulatory, clinical, governance and health-economic constraints of eSTI2 community testing and develop a wireless-web-based system for managing remote STI diagnosis. It will conduct a community-based proof-of-concept study of eSTI2 deployment in preparation for community-based trials of mobile-interfacing self-testing diagnostics.
5. Knowledge transfer and Networking: will promote: dissemination of research findings, inform on strategic challenges and sustain collaboration with industry in order to test novel diagnostic devices using the eSTI2 evaluation pipeline.

Career development in translation infection research will be provided to six interdisciplinary PhD studentships and two Academic Clinical Fellowships. Bidirectional collaboration with industry will provide financial sustainability beyond the 5 years of UKCRC funding. Impact: Significant enhancement in capacity for translational research into novel diagnostics aimed at improving treatment, reducing STI transmission and improving sexual health of high-risk groups.