Self-taken vaginal swabs and gonorrhoea detection

Comparison of self-taken vaginal swabs versus clinician taken urethral and endocervical swabs for the detection of gonorrhoea using the Gen-Probe Aptima Combo 2 assay

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42867448

Enrollment

4000

Registered

2010-06-24

Start date

2009-03-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Topic: Infection

Interventions

A self taken vulvo-vaginal swab analysed for gonorrhoea by the Aptima Combo 2 assay, followed by clinician taken urethral and endocervical samples analysed for gonorrhoea by culture then an endocervic

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026