Storage, transport and incubation for N. gonorrhoea samples

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55795067

Enrollment

Registered

2020-03-11

Start date

2018-12-01

Completion date

Unknown

Last updated

2023-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neisseria gonorrhoea infection Infections and Infestations

Interventions

If a patient decides to take part in the study, written informed consent will be taken. Participants will be asked to provide a swab sample (vaginal/cervix swabs for women and a ureth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Presenting to sexual health clinic with symptom(s) of Neisseria gonorrhoea 2.1. Presence of urethral or vaginal discharge and/or dysuria OR 2.2. Recent medical history and risk factors that in the opinion of the treating clinician warrants investigation for N. gonorrhoea infection

Exclusion criteria

Exclusion criteria: 1. Under the age of 18 years 2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity

Design outcomes

Primary

Measure	Time frame
The detection rates of the Sigma VCM compared to current (in)direct agar plating practise in Cumbrian sexual health clinics, measured using NAAT (PCR) at a single study visit	—

Secondary

Measure	Time frame
Measured at a single timepoint/study visit: 1. The detection rates of direct or indirect plating versus Sigma VCM, measured using NAAT (PCR) at a single study visit 2. Time between sample taken from patient to arrival in the microbiology department, measured using timing records in patient and laboratory records 3. Storage requirements, measured using feedback from clinical staff 4. Transport requirements, measured using feedback from clinical and laboratory staff 5. Incubation time, measured using laboratory records 6. Costs (including materials), measured using cost utilisation analysis	—

Measure

Time frame

Measured at a single timepoint/study visit: 1. The detection rates of direct or indirect plating versus Sigma VCM, measured using NAAT (PCR) at a single study visit 2. Time between sample taken from patient to arrival in the microbiology department, measured using timing records in patient and laboratory records 3. Storage requirements, measured using feedback from clinical staff 4. Transport requirements, measured using feedback from clinical and laboratory staff 5. Incubation time, measured using laboratory records 6. Costs (including materials), measured using cost utilisation analysis

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026