Evaluation of a rapid molecular test for Chlamydia trachomatis v1
Research type
Research Study
Full title
Evaluation of a rapid diagnostic platform for the molecular detection of Chlamydia trachomatis.
IRAS ID
95443
Contact name
Catherine A Ison
Contact email
Sponsor organisation
Public Health England
Clinicaltrials.gov Identifier
107550, PHE Project number
Research summary
Chlamydia trachomatis is the cause of the most common bacterial sexually transmitted infection in the United Kingdom, with over 200,000 cases diagnosed each year in England, and can cause serious complications of infertility and ectopic pregnancy. Approximately 75% of women will not have any symptoms and therefore do not know they are infected. Detection of infected individuals has been the subject of a national screening programme to promote opportunistic screening, particularly of young people between 16-24years old, where the greatest number of cases of infection are found. Diagnosis requires that a sample is taken, either a urine or self-taken vaginal swab, and transferred to a laboratory for testing. While this enables testing of large numbers of samples using accurate tests, there is a delay of 5-10 days before the result is ready during which the individual remains untreated and transmission of the infection can still occur. Newer technologies have enabled production of rapid and accurate tests that can be used at point of care (POC) and allows the patients to be diagnosed and treated at their first visit for care.
The aim of this study is to evaluate a new Point of care test for the diagnosis of chlamydia that uses molecular detection and can achieve an accurate result in 35 minutes.
The study will collect samples from women at three sexual health clinics to ensure sufficient patients with a positive result are enrolled and will use patient-consented samples. The study will be completed within four months and the results of the evaluation will not be used for patient care.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/1430
Date of REC Opinion
19 Sep 2014
REC opinion
Favourable Opinion