Self-taken vaginal swabs and gonorrhoea detectio

Completed

• Conditions: Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology; Infections and Infestations; Gonorrhoea

• Registration Number: ISRCTN42867448
• Lead Sponsor: eeds Teaching Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 4000

Inclusion Criteria

1. Women aged 16 years and over
2. Presenting for a new or re-registration visit
3. Wish to be tested for both chlamydia and gonorrhoea
4. Give consent

Exclusion Criteria

1. Women who are unwilling or unable to give verbal consent
2. Women who have taken antibiotics in the previous 28 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive and negative predictive values of the Gen-Probe Aptima Combo 2 assay for the detection of gonorrhoea using self-taken vaginal swabs compared with clinician taken urethral and endocervical swabs for the detection of gonorrhoea by standard culture.

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive and negative predictive values of self-taken vaginal swabs compared with clinician taken endocervical swabs for the detection of gonorrhoea using the Gen-Probe Aptima Combo 2 assay.