Precise Study: NG & MG point-of-care test evaluation
Research type
Research Study
Full title
A Point of care antimicrobial resistance test for Neisseria gonorrhoeae and Mycoplasma genitalium infection – ensuring accurate therapy and antibiotic stewardship in sexual health medicine.
IRAS ID
220470
Contact name
Tariq Sadiq
Contact email
Sponsor organisation
Joint Research & Enterprise Services (JRES)
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Testing for sexually transmitted infections (STIs) enables diagnosis and appropriate clinical management of individuals, thus preventing serious health consequences. It is an important public health intervention with potential to reduce onward transmission of infection to sexual partners, and reducing the emergence of antimicrobial resistance (AMR). New technologies, including point of care tests (POCTs), especially those that combine detection of the pathogen and AMR, may help overcome challenges of STI prevention by enabling immediate diagnosis and appropriate treatment, improving partner notification, quality of patient care and antibiotic stewardship.
Through a three-year NIHR i4i-funded grant (II-LB-0214-20005), the team at St George’s University of London have been working with Atlas Genetics, to develop a POCT for diagnosis and AMR for the two STIs Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG). We are now able to conduct a prospective diagnostic accuracy study of the test using patient-consented (additional to routine) clinical samples, to evaluate the Atlas io platforms and its associated cartridges. For NG, the primary outcome is to set the detection level whereby samples are considered negative and assess the test’s utility as a reflex test for patients already diagnosed with NG. For MG, we will look at the accuracy of detection and AMR. Secondary outcomes are an epidemiological description of the recruited population, and modelling clinical impact of POCTs.
We will work with Atlas Genetics and a number of UK NHS Genitourinary Medicine (GUM) clinics, over 12 months. Following informed consent, females will be asked to provide 2 additional vulvo-vaginal swabs, males an additional portion of first void urine, and men-who-have-sex-with men (MSM) two additional pharyngeal and rectal swabs. The results of the tests will not be used to inform patient care. Participants will only be recruited during one routine clinical visit, no follow up is required.REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/0097
Date of REC Opinion
15 Mar 2017
REC opinion
Further Information Favourable Opinion