Previous studies of the Neisseria gonorrhoeae (NG) lateral flow assay (LFA) have shown promising results. In East London, South Africa, the LFA demonstrated a sensitivity of 80% in asymptomatic women. However, a study in Zimbabwe reported a lower sensitivity of 65% among pregnant women attending antenatal care (ANC). This discrepancy raises important questions about the test's performance in pregnant women in the East London ANC population. Physiological changes during pregnancy may influence test accuracy, highlighting the need for further investigation in this specific population and setting.
This study aims to evaluate the performance, acceptability, and usability of the NG LFA among pregnant and symptomatic women attending clinics in East London. Participants will provide clinical samples that are tested using both the NG LFA and standard laboratory methods to assess diagnostic accuracy, including sensitivity and specificity. The study will specifically determine whether pregnancy affects the test's performance and whether the LFA is reliable for routine use in ANC clinics. Confirming its accuracy could enable wider implementation, improving case detection, treatment rates, and reducing the burden of gonorrhea in the community.
In addition to evaluating performance, the study will investigate the feasibility of self-collected samples. Self-collection offers privacy, convenience, and may increase participation in testing, particularly for women who prefer this method. It may also reduce the workload for healthcare providers, especially in resource-limited settings. The study will compare the accuracy of self-collected samples with clinician-collected samples to determine whether self-collection is a viable option in ANC and symptomatic populations.
The findings will provide crucial evidence to guide implementation of the NG LFA in primary care and ANC clinics, supporting timely diagnosis and treatment. If successful, this approach could strengthen gonorrhea screening programs, enhance patient-centered care, and contribute to better sexual and reproductive health outcomes for women in South Africa.
Women age ≥18 years
Pregnant women
Attending a study site for antenatal care
Willingness to participate and signed informed consent form (ICF)
Self-reported use of antimicrobial therapy within 21 days preceding enrolment
Use of vaginal douche or vaginal product in the previous 24 hours
Unable to provide specimens for testing
A medical condition, serious illness, or other condition that could interfer with study procedures or jeopardise participant safety Symptomatic population Inclusion -
1. Pregnant women 2. Symptomatic women 3. Healthcare workers (HCWs) population Systems Usability Score Survey \& TFA Acceptability Survey * HCWs using the NG LFA during month 3 of the study. Focus Group Discussions (FGD) * HCWs actively involved in conducting the study Focus Group Discussions (FGD) - Non-Study Participants * HCWs working at the study site but NOT directly involved in the NG LFA study procedures
Other
Cross-sectional
Novel Lateral Flow Assay for Neisseria gonorrhoeae
Diagnostic testThe clinical claims for the NG LFA are centred around its potential to provide rapid, accurate, and accessible POC diagnosis for NG infection in non-pregnant and pregnant women. It is intended to be used for the detection of NG infections in vaginal swab specimens collected from both symptomatic non-pregnant women and women attending ANC. The NG LFA aims to offer several advantages over traditional testing, including: 1\. Rapid Results: The LFA is designed to provide results within 30 minutes, enabling faster diagnosis and treatment decisions compared to laboratory-based tests that may take hours or days. 2\. Ease of Use: The LFA is intended to be user-friendly, requiring minimal training and resources. This makes it suitable for use in various settings, including primary healthcare facilities and ANC clinics. 3\. Affordability: The LFA is expected to be more cost-effective than current molecular diagnostic methods, potentially expanding access to testing in resource-limited settings.
To determine the diagnostic accuracy of the NG LFA for the detection of NG in provider-collected vaginal samples from pregnant women attending ANC when compared to Xpert® CT/NG as the reference standard.
Point estimates of sensitivity and specificity with 95% confidence intervals (Wilson's score method) among pregnant ANC attendees.
To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples among symptomatic non-pregnant women.
Point estimates of sensitivity and specificity with 95% confidence intervals (Wilson's score method) among symptomatic non-pregnant women.
To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from pregnant women attending ANC.
Point estimates of the percentage differences with 95% confidence intervals (Tango's score method) of the diagnostic performance metrics between self-collected and provider-collected vaginal samples for the detection of NG in pregnant ANC attendees.
To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from symptomatic non-pregnant women.
Point estimates of the percentage differences with 95% confidence intervals (Tango's score method) of the diagnostic performance metrics between self-collected and provider-collected vaginal samples for the detection of NG in non-pregnant symptomatic women.
To compare the safety of self-collection of vaginal swabs vs provider collection among pregnant women attending ANC and symptomatic non-pregnant women.
The number of adverse events reported following self-collection of vaginal swabs or collection by health service providers among pregnant women attending ANC and symptomatic non-pregnant women.
Click on the lead sponsor to view all of their trials.
Foundation for Professional Development (Pty) Ltd
Lead sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborator
