Patient-consented samples for STI diagnostic & biomarker evaluation
Research type
Research Study
Full title
Study protocol for evaluations of diagnostic tests and biomarkers for sexually transmitted infections (STIs) using patient-consented, additional to routine, clinical samples
IRAS ID
126709
Contact name
Tariq Sadiq
Contact email
Sponsor organisation
St George’s NHS Healthcare Trust
Research summary
Testing for sexually transmitted infections (STIs) provides care for the individual, by enabling treatment which can prevent serious consequences of infection, and is also a public health intervention with the potential to reduce onward transmission of infection to sexual partners. New testing technologies, including point-of-care tests that test for a number of infections, may help overcome some of the challenges of STI prevention by enabling immediate treatment for a range of infections and improving partner notification. In addition, the discovery and evaluation of the diagnostic potential of multiple pathogen and inflammatory biomarkers ("a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention") means these can subsequently be transferred onto existing and novel diagnostic platforms.
The aim of the study is to facilitate the development and take-up of rapid, accurate, point-of-care diagnostic tests and platforms for STIs, and high quality clinical studies investigating potential biomarkers of STIs. This study will use patient-consented clinical samples, additional to routine clinical samples, to inform the development of, and conduct evaluations of, tests and biomarkers for STIs.
We will work with a number of industrial partners and different testing devices. The methods for sample and data collection for evaluations in this study will be similar. Individual contracts will be drawn up and signed for each of the industrial partners, outlining responsibilities under the Human Tissue Act. The results of the tests under evaluation will not be used to inform patient care.
This study is being conducted by eSTI2: a UKCRC-funded consortium. This study, as part of the consortium, is funded until February 2016.
REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/0691
Date of REC Opinion
1 Aug 2013
REC opinion
Further Information Favourable Opinion