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. (GO-SA)

Evaluation of Performance, Acceptability, and Usability of a Novel Lateral Flow Assay for Point-of-Care Detection of Neisseria Gonorrhoeae Infection Among Pregnant and Symptomatic Women in South Africa

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.

Study Overview

• Status: Recruiting
• Conditions: Neisseria Gonorrheae Infection
• Intervention / Treatment: Diagnostic test: Novel Lateral Flow Assay for Neisseria gonorrhoeae

Detailed Description

Background and Rationale :

Gonorrhoea remains a significant public health challenge globally, particularly in South Africa, where it is considered endemic. Untreated gonorrhoea, which is now becoming more resistant to antibiotics, can lead to severe complications, including pelvic inflammatory disease, infertility, adverse pregnancy outcomes, and increased susceptibility to HIV. Pregnant women are especially vulnerable as untreated gonorrhoea can result in miscarriage, preterm birth, and neonatal infection. Early and accurate diagnosis is crucial for timely treatment and the prevention of these adverse outcomes.

Nucleic acid amplification tests (NAATs) are considered the most reliable diagnostic tool for gonorrhoea. However, their high cost, long turnaround time and demanding infrastructure requirements often render them inaccessible in resource-constrained environments. The NG LFA, a rapid, point-of-care test developed by FIND, offers a potential solution for these settings.

Previous NG LFA performance studies have shown promising results, with a sensitivity of 80% in asymptomatic women in East London1. However, a study in Zimbabwe found a lower sensitivity of 65% among pregnant women attending Antenatal Care (ANC). This discrepancy raises questions about the LFA's performance in this specific population and setting. The observed difference in sensitivity between asymptomatic women and pregnant women highlights the need to investigate the LFA's performance, specifically in the ANC population in East London. It has been hypothesised that pregnancy may induce physiological changes that affect the test's accuracy. Therefore, further investigation is needed to confirm this potential impact. If the NG LFA proves reliable and accurate in this setting, its widespread implementation in ANC clinics could significantly improve case detection and treatment rates, ultimately reducing the burden of gonorrhoea in the community.

This study will also investigate the potential for self-collected samples. Self-collection offers several benefits, such as increased privacy and convenience, which could encourage more women to get tested. Additionally, it may reduce the workload for healthcare providers, especially in areas with limited resources. We will evaluate the feasibility and accuracy of self-collected samples compared to those collected by clinicians in the ANC population and symptomatic women who may prefer this method.

Objectives:

Primary Objective

1. 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.

   Secondary Objectives

2. To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples among symptomatic non-pregnant women.
3. 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.
4. 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.
5. To compare the safety of self-collection of vaginal swabs vs provider collection among pregnant women attending ANC and symptomatic non-pregnant women.
6. To assess healthcare workers' acceptability, usability, and preferences regarding the NG LFA systems integration compared to the reference method.
7. To assess the acceptability and preference for self-collected vaginal samples compared to provider-collected samples among pregnant ANC attendees and symptomatic non-pregnant women and healthcare workers.

• Study Type: Observational
• Enrollment (Estimated): 1239

Contacts and Locations

• Study Contact: Name: Mandisa M Mdingi, Master of Public Health; Phone Number: +27 73 706 9068; Email: mandisam@founadtion.co.za
• Study Contact Backup: Name: Dr Sarita Naidoo, PhD; Phone Number: +27 (0) 12 110 4080; Email: saritan@foundation.co.za

Study Locations

• South Africa
  • Eastern Cape
    • East London, Eastern Cape, South Africa, 5247
      • Recruiting
      • 1. Nontyatyambo CHC 2. Empilweni Gompo CHC 3. Duncan Village Day Hospital 4. Grey Gateway Clinic 5. Ndevana Clinic
      • Contact: Mandisa M Mdingi; Phone Number: +27 737069068; Email: mandisam@foundation.co.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

ANC population

• Women age ≥18 years
• Pregnant women
• Attending a study site for antenatal care
• Willingness to participate and signed informed consent form (ICF)

Exclusion Criteria:

• 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 -
• Non pregnant women age ≥18 years
• Diagnosis of VDS. Diagnosis of VDS will be based on self-reported presence ofsymptoms consistent with VDS, such as increased or abnormal vaginal discharge
• Willingness to participate and sign ICF Exclusion -
• 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 interfere with study procedures or jeopardise participant safety

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pregnant Women Cohort and Symptomatic Women Cohort; This is a cross-sectional, single time-point study with a paired design to determine the diagnostic accuracy of the NG LFA against the Xpert® CT/NG as a reference standard in vaginal samples collected from pregnant women attending ANC and to compare the accuracy and safety of self-collected and provider-collected samples in both non-pregnant symptomatic and pregnant ANC attendees.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
To assess healthcare workers' acceptability, usability, and preferences regarding the NG LFA systems integration compared to the reference method.	Mixed methods: Acceptability; distribution of acceptability questionnaire scores; usability; distribution of System Usability Scores; perceptions on acceptability, usability, and preferences of systems integration from qualitative semi-structured interviews and focus group discussions.	Systems usability score survey and the TFA acceptability survey relating to the NG LFA will be administered to all healthcare workers who are manipulating the NG LFA at month 3 (projected mid-point of participant enrolment) and at month 5.
To assess the acceptability and preference for self-collected vaginal samples compared to provider-collected samples among pregnant ANC attendees and symptomatic non-pregnant women and healthcare workers.	Mixed methods: Distribution of acceptability questionnaire score, perceptions on acceptability and preference from qualitative focus group discussions. The proportion of participants in each group who prefer self-collected samples over provider-collected samples.	Month 3

Collaborators and Investigators

• Sponsor: Foundation for Professional Development (Pty) Ltd
• Collaborators: Foundation for Innovative New Diagnostics, Switzerland
• Investigators: Principal Investigator: Mandisa M Mdingi, Master of Public Health, Foundation for Professional Development; Principal Investigator: Dr Birgitta Gleeson, PhD, Foundation for Innovative New Diagnostics, Switzerland

Publications and helpful links

General Publications

• Riddell MA, Vallely LM, Mengi A, Badman SG, Low N, Wand H, Bolnga JW, Babona D, Mola GDL, Wiseman V, Kelly-Hanku A, Homer CSE, Morgan C, Luchters S, Whiley DM, Robinson LJ, Au L, Pukai-Gani I, Laman M, Kariwiga G, Toliman PJ, Batura N, Tabrizi SN, Rogerson SJ, Garland SM, Guy RJ, Peeling RW, Pomat WS, Kaldor JM, Vallely AJB; WANTAIM study group. Point-of-care testing and treatment of sexually transmitted and genital infections to improve birth outcomes in high-burden, low-resource settings (WANTAIM): a pragmatic cluster randomised crossover trial in Papua New Guinea. Lancet Glob Health. 2024 Apr;12(4):e641-e651. doi: 10.1016/S2214-109X(24)00004-4.
• Gleeson B, Piton J, Mazzola L, McHugh S, Bender J, Lear M, Gavrikova T, Van Der Pol B, Daniels B, Osborn J, Dailey P, Ferreyra C. Development of a Novel Fluorescent-Based Lateral Flow Assay for the Detection of Neisseria gonorrhoeae at the Point of Care. Sex Transm Dis. 2024 Mar 1;51(3):186-191. doi: 10.1097/OLQ.0000000000001913. Epub 2023 Dec 19.
• Peters RP, Dubbink JH, van der Eem L, Verweij SP, Bos ML, Ouburg S, Lewis DA, Struthers H, McIntyre JA, Morre SA. Cross-sectional study of genital, rectal, and pharyngeal Chlamydia and gonorrhea in women in rural South Africa. Sex Transm Dis. 2014 Sep;41(9):564-9. doi: 10.1097/OLQ.0000000000000175.
• Peters RPH, Klausner JD, Mazzola L, Mdingi MM, Jung H, Gigi RMS, Piton J, Daniels J, de Vos L, Adamson PC, Gleeson B, Ferreyra C. Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in syndromic management settings: a cross-sectional performance evaluation. Lancet. 2024 Feb 17;403(10427):657-664. doi: 10.1016/S0140-6736(23)02240-7. Epub 2024 Feb 6.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: GO-SA
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Gonorrhea
• Other Study ID Numbers: GO-SA AM007; DFATD-Canada (Other Identifier: Department of Foreign Affairs, Trade and Development (DFATD), Canada)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No