Performance, Acceptability, and Usability of a Novel Rapid Lateral Flow Test for Detecting Neisseria Gonorrhoeae in Pregnant and Symptomatic Women Attending Clinics in South Africa.

Summary

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.

Conditions

• Neisseria Gonorrheae Infection

Interventions

DIAGNOSTIC_TEST

Novel Lateral Flow Assay for Neisseria gonorrhoeae

The 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.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland

  collaborator OTHER

• Foundation for Professional Development (Pty) Ltd

  lead OTHER

Principal Investigators

• Mandisa M Mdingi, Master of Public Health · Foundation for Professional Development

• Dr Birgitta Gleeson, PhD · Foundation for Innovative New Diagnostics, Switzerland

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-11

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• South Africa

Study Locations