Evaluation of the MAST multiplex STI assay
Research type
Research Study
Full title
Optimisation and preliminary clinical evaluation of MAST POC assay performance for detecting Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium and Candida species.
IRAS ID
156937
Contact name
Patrick Horner
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
The MAST multiplex point of care test is a fully integrated rapid molecular diagnostic device designed to give an accurate test result for the diagnosis of S.T.I.s at the initial visit. This study aims to evaluate the MAST multiplex point of care test alongside comparable diagnostic tests, for each of the following 5 sexually transmitted infections; chlamydia, gonorrhoea, Trichomonas vaginalis, Mycoplasma genitalium and candida in patients attending the genitourinary medicine (GU) clinic. This test has been developed by a consortium consisting of Mast Group Ltd (Lead Industrial Partner), University of Liverpool, John Moore University of Liverpool and Public Health England, with funding from the Technology Strategy Board (now Innovate UK). The prototype test now needs to be evaluated using routine clinical specimens, to provide an early indication of test sensitivity, specificity and reliability, and to allow the developers of the test to identify any problems and make sure it is working well. This will then lead onto a definitive study to confirm performance of the final version of the test in terms of sensitivity and specificity in a range of clinical specimens from a representative range of patient groups in order to obtain CE approval. Point of care testing for sexually transmitted infections (STIs) is likely to transform the delivery of sexual health services.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0325
Date of REC Opinion
10 Dec 2015
REC opinion
Favourable Opinion