Evaluation of a novel near-patient serological test for syphilis
Research type
Research Study
Full title
Evaluation of a novel near-patient serological test for syphilis
IRAS ID
365396
Contact name
Michael Marks
Contact email
Sponsor organisation
London School of Hygiene and Tropical Medicine
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
Background
Syphilis cases in the UK have increased significantly over the past 20 years, particularly among men who have sex with men. Currently, diagnosing syphilis requires blood samples to be sent to laboratories, which can take several days to get results.
We will evaluate a new rapid test called the Chembio TnT that could provide results during a single clinic visit.This is a laboratory study only—no patients will be directly involved. Researchers will use 500 leftover blood samples from people who were already tested for syphilis as part of their routine care. These samples would normally be discarded. All patient information will be removed to protect privacy. The researchers will test these samples with the new rapid test and compare the results to the standard laboratory tests to see how accurate it is. There are no risks to participants as this study only uses anonymised leftover samples.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
25/YH/0259
Date of REC Opinion
10 Dec 2025
REC opinion
Favourable Opinion