STRINGS - Storage, Transport & Incubation for N. Gonorrhoea Samples
Research type
Research Study
Full title
A single-centre, controlled, prospective study to investigate the performance of the novel Sigma VCM diagnostic storage and transport kit compared to current standard methods to detect Neisseria Gonorrhoea
IRAS ID
243037
Contact name
Matt Phillips
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 10 months, 30 days
Research summary
The incidence of gonorrhoea is potentially underestimated because of suboptimal processing of samples, diagnosis methodology, case reporting and surveillance. Undetected or inadequately treated Gonorrhoea can cause serious reproductive health consequences and poses a threat to public health due to the emergence of drug-resistant strains; timely and accurate diagnosis is therefore essential. Despite high specificity tests available, N. Gonorrhoea bacteria are technically difficult to preserve and recover from clinical specimens. Any delay in processing, transport and incubation of direct culture plates can significantly reduce the sensitivity of the test, resulting in false negative results and non-treatment. Novel swab transport systems have become increasingly important due their low cost, ease of use and the ability to maintain viability for aerobic, anaerobic and fastidious microorganisms – such as N. gonorrhoea – over extended times. This may have benefits in clinic settings across the UK, particularly in rural settings where transport times to laboratories may be longer. This study aims to assess the performance of a novel swab transport system – Sigma VCM (product code MW911S, marketed by the company MWE) – compared to the current method of plating onto a solid growth medium to prepare, transport and detect Neisseria Gonorrhoea in sexual health clinics and to assess the potential cost-effectiveness and benefits in terms of storage, transport and incubation time
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1936
Date of REC Opinion
30 Oct 2018
REC opinion
Further Information Favourable Opinion