CLASiS - Cobas Liat Assessment in Sexual health Services
Research type
Research Study
Full title
The clinical utility of the Roche Cobas Liat Point of Care Test to inform targeted antibiotic use for Chlamydia, Gonorrhoea and Mycoplasma genitalium in Sexual Health Services
IRAS ID
368875
Contact name
Jaime Vera
Contact email
Sponsor organisation
University Hospitals Sussex NHS Foundation Trust
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
Rates of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG) continue to rise in England, posing a significant public health challenge. These infections are frequently asymptomatic but can result in serious reproductive health complications if untreated. Current diagnostic pathways in sexual health services rely on central laboratory-based nucleic acid amplification tests (NAATs), with turnaround times of several days. As a result, many symptomatic individuals and sexual contacts are treated presumptively, contributing to unnecessary antibiotic use and increasing the risk of antimicrobial resistance, particularly for NG and MG.
This study evaluates the implementation of the Roche cobas® Liat® CT/NG/MG assay, a CE-marked, ultra-rapid molecular point-of-care test (POCT) that delivers results within approximately 20 minutes. The assay has demonstrated high concordance with laboratory-based NAATs and enables same-visit diagnosis and treatment. The study aims to assess whether access to rapid CT, NG and MG results at the point of care reduces unnecessary antibiotic prescribing compared with current standard care pathways.
The study is a non-randomised, pre–post interventional evaluation conducted in a walk-in sexual health clinic in Brighton, UK. A 12-week baseline phase will retrospectively collect data on antibiotic prescribing, clinic flow and partner notification under standard care. Following pathway co-design and staff training, the intervention phase will introduce the cobas® Liat® CT/NG/MG assay into routine clinical workflows for a further 12 weeks. Outcomes during the intervention will be compared with baseline using a before-and-after approach.
Secondary objectives include evaluating the impact on the number of clinic visits per attendee, patient satisfaction with point-of-care testing, and service efficiency. Brief questionnaires will be used to explore patient and healthcare professional experience, acceptability and operational feasibility. By generating real-world evidence on clinical and operational impact, this study will inform antimicrobial stewardship efforts and the future integration of rapid molecular diagnostics into NHS sexual health services.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
26/EM/0113
Date of REC Opinion
19 Jun 2026
REC opinion
Further Information Favourable Opinion