GONDOLA, GONorrhoea Detection using Laboratory Assessment
Research type
Research Study
Full title
A single-centre, prospective evaluative study to investigate the performance of the Bio Med InTray® GC (a sample collection, transport and culture in-vitro device), compared to current standard methods, to microbiologically detect Neisseria Gonorrhoeae
IRAS ID
261500
Contact name
Matt Phillips
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
ISRCTN Number
ISRCTN16307168
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 9 months, 31 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. Gonorrhoeae 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. gonorrhoeae – 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 incubation and transport system – BioMed’s InTray™ GC – compared to the current method of plating onto a solid growth medium to prepare, transport and detect Neisseria Gonorrhoea in sexual health clinics. Further the objective is to assess the potential cost-effectiveness and benefits in terms of storage, transport and incubation time
REC name
South East Scotland REC 01
REC reference
19/SS/0050
Date of REC Opinion
25 Apr 2019
REC opinion
Further Information Favourable Opinion