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.

NCT07530406 | Recruiting DMC

• 2 other identifiers: GO-SA AM007DFATD-Canada
• Study Type: observational
• Target: 1,239
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

GO-SA

Outcome Measures

Primary Outcomes (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.

  Point estimates of sensitivity and specificity with 95% confidence intervals (Wilson's score method) among pregnant ANC attendees.

  Baseline

Secondary Outcomes (6)

• To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples 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.

  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.

  Baseline

• To compare the safety of self-collection of vaginal swabs vs provider collection 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.

  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.

Study Arms (1)

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

Interventions

Novel Lateral Flow Assay for Neisseria gonorrhoeae DIAGNOSTIC_TEST

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.

Pregnant Women Cohort and Symptomatic Women Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: * Women age ≥18 years. * Pregnant and symptomatic women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Foundation for Professional Development (Pty) Ltd: lead
• Foundation for Innovative New Diagnostics, Switzerland: collaborator

Study Sites (1)

1. Nontyatyambo CHC 2. Empilweni Gompo CHC 3. Duncan Village Day Hospital 4. Grey Gateway Clinic 5. Ndevana Clinic

East London, Eastern Cape, 5247, South Africa

RECRUITING

Related Publications (4)

• 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.

  PMID: 38485431 BACKGROUND

• 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.

  PMID: 38412465 BACKGROUND

• 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.

  PMID: 25118973 BACKGROUND

• 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.

  PMID: 38335982 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Deidentified dry flocked swabs

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Mandisa M Mdingi, Master of Public Health

  Foundation for Professional Development

  PRINCIPAL INVESTIGATOR

• Dr Birgitta Gleeson, PhD

  Foundation for Innovative New Diagnostics, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandisa M Mdingi, Master of Public Health

CONTACT

+27 73 706 9068; mandisam@founadtion.co.za

Dr Sarita Naidoo, PhD

CONTACT

+27 (0) 12 110 4080; saritan@foundation.co.za

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: September 11, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

ZA (1)