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
Conditions: Neisseria Gonorrheae Infection
Sponsor: Foundation for Professional Development (Pty) Ltd

 
 
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Clinical Performance Study Plan (CPSP)  
 
 
 
 

 
 
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Approval 
Revision history 
 
This document may contain confidential, proprietary and/or trade secret information. Any person accepting this 
document and/or information agrees to make no disclosure, use or duplication except as authorised in writing by 
the Foundation for Professional Development (FPD). 
 
 
 
 
 
 
 
Name  
Function 
Date 
Signature 
Author 
Birgitta Gleeson  
Senior Scientist, FIND 
08/08/2024 
 
 
Reviewer 
Dr Ranjana Gigi 
Medical oversight 
28/10/2024 
 
 
Reviewer 
 
 
 
 
 
Approver 
Mandisa Mdingi 
Principal Investigator 
28/10/2024 
 
 
Approver 
Dr Sarita Naidoo 
Sub-Investigator 
15/04/2025 
 
 
Version  
Effective Date 
Description of change 
Author 
Approver 
1.0 
22/10/2024 
 
 
 
1.1 
15/04/2025 
Any samples that have not been transferred to. 
the University of Pretoria will only be shipped to 
the FIND biobank in the United States upon 
receipt of approval from the Faculty of Health 
Sciences Research Ethics Committee and 
following the execution of a Material Transfer 
Agreement (MTA) between FPD and FIND, which 
will be submitted to the Faculty of Health 
Sciences Research Office.  
  
  
  
Change of study staff 
New Sub-Investigator: Dr Sarita Naidoo, FPD  
Previous Sub-Investigator: Dr Cecilia Ferreyra, 
FIND 
Mandisa 
Mdingi, FPD 
Birgitta 
Gleeson, FIND  

 
 
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Clinical Performance Study Plan (CPSP) 
 
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.   
 
Type of performance study: 
In vitro diagnostic (IVD) device clinical performance study 
Study Design Type: 
×Observational study 
X Cross-sectional design 
☐ Longitudinal design 
☐ Retrospective design 
☐ Prospective design 
☐ Prospective-retrospective design 
☐ Interventional Study 
☐ Using leftover/archived specimens 
☐ Requiring surgically invasive sample-taking 
☐ Involving additional invasive procedure 
Registration: 
clinicaltrials.gov 
Reference number/Identifier: 
AM007 
Principal Investigator(s): 
PI - Mandisa Mdingi 
Research Manager 
Foundation for Professional Development (FPD), Research Unit  
East London Office, 16 Surrey Road, Vincent, East London, South Africa 
mandisam@foundation.co.za  
Sub-I – Dr Sarita Naidoo 
Head of Department 
Foundation for Professional Development (FPD), Research Unit  
East London Office, 16 Surrey Road, Vincent, East London, South Africa 
saritan@foundation.co.za   
Coordinating Principal Investigator NA  
Sponsor 
Foundation for Professional Development (FPD), 
Knowledge Park, 173 Mary Road, The Willows, Pretoria 
FPD Research Unit 
East London Office, 16 Surrey Road, Vincent, East London, South Africa 
IVD device: 
NG LFA and NG LFA reader  
FIND developed prototype NG LFA and reader   
Reader Software version – FIND-Reader-beta-1.2.1 
Manufacturer of the IVD device: 
DCN Dx (No commercial manufacturer to date)  

 
 
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CPSP Version and Date:  
Version 1.1 15/04/2025 
 
CONFIDENTIALITY STATEMENT 
The information contained in this document, especially unpublished data, is confidential and the property of FPD (e.g. the 
Sponsor). The information may not – in whole or in part – be transmitted, reproduced, published or disclosed to others 
than the applicable Competent Ethics Committee(s) and Competent Authority(ies) without prior written authorisation 
from FPD (e.g. the Sponsor) except to the extent necessary to obtain informed consent from those who will participate in 
the investigation. 
 
SUMMARY OF THE REVISION HISTORY IN CASE OF AMENDMENTS 
 
 
 
 
 
 
 
Version  
Effective Date 
Description of change 
Reason for the change 
1.0 
22/10/2024 
 
 
1.1 
15/04/2025 
Any samples that have not been transferred to. 
the University of Pretoria will only be shipped to 
the FIND biobank in the United States upon 
receipt of approval from the Faculty of Health 
Sciences Research Ethics Committee and 
following the execution of a Material Transfer 
Agreement (MTA) between FPD and FIND, which 
will be submitted to the Faculty of Health 
Sciences Research Office. 
 
 
 
Change of study staff-  
New Sub-Investigator: Dr Sarita Naidoo, 
FPD 
Previous Sub-Investigator: Dr Cecilia 
Ferreyra 
As per South African Good Clinical 
Practice, no samples may be 
shipped outside the country or 
shared with other researchers, if 
not approved by the Faculty of 
Health Science 
Research Ethics Committee and a 
signed MTA submitted to the 
Faculty of Health Science 
Research Ethics Committee. 
Both organisations, FIND and FPD 
agreed to have local Sub-
Investigator 

 
 
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SIGNATURE PAGE(S) 
 
 
Sponsor:  
The Sponsor representatives and FIND have developed, reviewed, and approved the CPSP version 1.0 22/10/2024,and 
confirm hereby to oversee and coordinate the investigation according to the CPSP, the current version of the World 
Medical Association Declaration of Helsinki, the CIOMS International Guidelines for Health Research Involving Human 
Participants, ISO 20916 norm, ICH-GCP when applicable, and the applicable local regulatory requirements. 
Primary contact person: Mandisa Mdingi 
 
East London, 28 October 2024 
Place/Date 
Signature 
 
Medical Lead: Dr Ranjana Gigi 
 
 
East London, 28 October 2024 
Place/Date 
Signature 
 
 
Sub investigator: Dr Sarita Naidoo  
 
 
East London, 15 April 2025 
Place/Date 
Signature 
 
 
 
 
ID number of the clinical 
performance study 
AM007 
Title 
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 

 
 
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Principal Investigator: Mandisa Mdingi 
I have read and understood this CPSP version 1.1 15/04/2025 and agree to conduct the investigation according to the CPSP, 
the current version of the World Medical Association Declaration of Helsinki, the CIOMS International Guidelines for Health 
Research Involving Human Participants, ISO 20916 norm, ICH-GCP when applicable, and the local legally applicable 
requirements.    
                                           
 
 
   East London, 15 April 2025                                                               
Place/Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Table of Contents 
APPROVAL -------------------------------------------------------------------------------------------------------------------------------------------------- 2 
REVISION HISTORY --------------------------------------------------------------------------------------------------------------------------------------- 2 
SYNOPSIS -------------------------------------------------------------------------------------------------------------------------------------------------- 12 
ABBREVIATIONS ----------------------------------------------------------------------------------------------------------------------------------------- 18 
INVESTIGATION SCHEDULE -------------------------------------------------------------------------------------------------------------------------- 19 
1 
INVESTIGATION ADMINISTRATIVE STRUCTURE ---------------------------------------------------------------------------------------- 21 
1.1 
SPONSOR -------------------------------------------------------------------------------------------------------------------------------------- 21 
1.2 
PRINCIPAL INVESTIGATOR(S) AND STUDY SITE(S) ------------------------------------------------------------------------------------------- 21 
1.3 
BIOSTATISTICIAN ------------------------------------------------------------------------------------------------------------------------------ 21 
1.4 
MEDICAL OVERSIGHT ------------------------------------------------------------------------------------------------------------------------- 21 
1.5 
LABORATORY (FOR DISCORDANCE TESTING) ------------------------------------------------------------------------------------------------- 21 
1.6 
MONITORING INSTITUTION ------------------------------------------------------------------------------------------------------------------- 21 
1.7 
DATA SAFETY MONITORING COMMITTEE AND THE TRIAL STEERING COMMITTEE ------------------------------------------------------- 21 
2 
BACKGROUND AND RATIONALE ------------------------------------------------------------------------------------------------------------ 22 
2.1 
BACKGROUND AND RATIONALE OF THE CLINICAL PERFORMANCE STUDY ------------------------------------------------------------------ 22 
3 
CLINICAL PERFORMANCE STUDY OBJECTIVES AND OUTCOMES (ENDPOINTS) ----------------------------------------------- 23 
3.1 
STUDY OBJECTIVES---------------------------------------------------------------------------------------------------------------------------- 23 
Primary Objective---------------------------------------------------------------------------------------------------------------------------------------- 23 
Secondary Objective(s) --------------------------------------------------------------------------------------------------------------------------------- 23 
3.2 
STUDY OUTCOMES (ENDPOINTS) ------------------------------------------------------------------------------------------------------------ 24 
Primary Outcome ---------------------------------------------------------------------------------------------------------------------------------------- 24 
Secondary Outcome(s) --------------------------------------------------------------------------------------------------------------------------------- 24 
Safety Outcome(s) --------------------------------------------------------------------------------------------------------------------------------------- 24 
4 
DESIGN OF THE CLINICAL PERFORMANCE STUDY -------------------------------------------------------------------------------------- 25 
4.1 
STUDY DESIGN -------------------------------------------------------------------------------------------------------------------------------- 25 
Justification for choice of the study population ------------------------------------------------------------------------------------------------- 25 
Inclusion and exclusion criteria for participants providing specimens. -------------------------------------------------------------------- 25 
Justification for selection of study specimens ---------------------------------------------------------------------------------------------------- 26 
4.2 
REFERENCE METHODS ------------------------------------------------------------------------------------------------------------------------ 26 
Gold Standard(s) method(s) -------------------------------------------------------------------------------------------------------------------------- 26 
Routine Diagnostic method(s) (if applicable) ---------------------------------------------------------------------------------------------------- 27 
4.3 
ANALYTICAL PERFORMANCE OF NG LFA --------------------------------------------------------------------------------------------------- 27 
4.4 
CLINICAL PERFORMANCE --------------------------------------------------------------------------------------------------------------------- 27 
Clinical claims and intended clinical IVD device performance to be evaluated --------------------------------------------------------- 27 
Parameters of clinical performance to be determined ---------------------------------------------------------------------------------------- 28 
Justification for chosen of clinical performance parameters --------------------------------------------------------------------------------- 28 

 
 
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5 
IDENTIFICATION OF THE IVD DEVICE UNDER INVESTIGATION --------------------------------------------------------------------- 28 
5.1 
SUMMARY DESCRIPTION OF THE IVD DEVICE UNDER INVESTIGATION --------------------------------------------------------------------- 28 
6 
ETHICAL ASPECTS AND RISK EVALUATION ----------------------------------------------------------------------------------------------- 29 
6.1 
ETHICAL ASPECTS ----------------------------------------------------------------------------------------------------------------------------- 29 
Registration of the investigation -------------------------------------------------------------------------------------------------------------------- 29 
Competent Ethics Committee (CEC) ---------------------------------------------------------------------------------------------------------------- 29 
Reporting duties to the Competent Authorities (CA) ------------------------------------------------------------------------------------------- 30 
Ethical conduct of the investigation ---------------------------------------------------------------------------------------------------------------- 30 
Declaration of Interests -------------------------------------------------------------------------------------------------------------------------------- 30 
Patient Information and Informed Consent ------------------------------------------------------------------------------------------------------ 30 
Participant privacy and confidentiality ------------------------------------------------------------------------------------------------------------ 31 
Dissemination of study findings and post-study access --------------------------------------------------------------------------------------- 31 
Community engagement ------------------------------------------------------------------------------------------------------------------------------ 32 
6.2 
RISK EVALUATION ----------------------------------------------------------------------------------------------------------------------------- 32 
Anticipated clinical benefits -------------------------------------------------------------------------------------------------------------------------- 33 
Anticipated risks ----------------------------------------------------------------------------------------------------------------------------------------- 33 
Steps to control or mitigate the risks --------------------------------------------------------------------------------------------------------------- 34 
Residual risks associated with clinical performance study ----------------------------------------------------------------------------------- 34 
Risk-to-Benefit rationale ------------------------------------------------------------------------------------------------------------------------------- 34 
7 
CLINICAL PERFORMANCE STUDY PROCEDURES ---------------------------------------------------------------------------------------- 36 
7.1 
RECRUITMENT OF PRINCIPAL INVESTIGATORS AND STUDY SITES -------------------------------------------------------------------------- 36 
Principal Investigators recruitment procedure -------------------------------------------------------------------------------------------------- 36 
Study Site recruitment procedure ------------------------------------------------------------------------------------------------------------------- 36 
7.2 
STUDY PARTICIPANTS: RECRUITMENT, SCREENING, ENROLMENT, WITHDRAWAL AND DISCONTINUATION ------------------------------ 36 
Participant recruitment and screening procedure ---------------------------------------------------------------------------------------------- 36 
Participant enrolment procedure ------------------------------------------------------------------------------------------------------------------- 36 
Participant compliance with clinical investigation intervention ---------------------------------------------------------------------------- 37 
Participant withdrawal or discontinuation procedure ----------------------------------------------------------------------------------------- 37 
7.3 
ACCOUNTING FOR PARTICIPANTS ------------------------------------------------------------------------------------------------------------ 37 
7.4 
METHODS FOR MINIMISING BIAS ----------------------------------------------------------------------------------------------------------- 37 
7.5 
HANDLING OF THE IVD DEVICE UNDER INVESTIGATION ------------------------------------------------------------------------------------ 38 
IVD device labelling procedure ----------------------------------------------------------------------------------------------------------------------- 38 
IVD device supply procedure-------------------------------------------------------------------------------------------------------------------------- 38 
IVD device storage procedure ------------------------------------------------------------------------------------------------------------------------ 38 
IVD device return or disposal procedure ---------------------------------------------------------------------------------------------------------- 39 
IVD device accountability procedure --------------------------------------------------------------------------------------------------------------- 40 
7.6 
SPECIMEN COLLECTION ----------------------------------------------------------------------------------------------------------------------- 40 
Specimen collection procedure overview ---------------------------------------------------------------------------------------------------------- 40 
NG LFA kit-specific swab (self-collected) ---------------------------------------------------------------------------------------------------------- 41 
Xpert® CT/NG Vaginal Specimen Collection (provider collected) --------------------------------------------------------------------------- 41 
NG LFA kit-specific swab (provider collected) ---------------------------------------------------------------------------------------------------- 42 

 
 
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Flocked swab (Storage/discordance) (provider collected) ------------------------------------------------------------------------------------ 42 
7.7 
SPECIMEN-ID ASSIGNMENT PROCEDURE ---------------------------------------------------------------------------------------------------- 42 
Specimen handling procedure ------------------------------------------------------------------------------------------------------------------------ 42 
Specimen transport procedure ----------------------------------------------------------------------------------------------------------------------- 43 
Specimen disposal procedure ------------------------------------------------------------------------------------------------------------------------ 43 
Specimen accountability procedure ---------------------------------------------------------------------------------------------------------------- 43 
7.8 
SPECIMEN ASSESSMENT ---------------------------------------------------------------------------------------------------------------------- 43 
Testing procedure --------------------------------------------------------------------------------------------------------------------------------------- 43 
Procedure for assessment of the outcome -------------------------------------------------------------------------------------------------------- 46 
Procedure for each visit -------------------------------------------------------------------------------------------------------------------------------- 48 
Suspension or termination of the clinical performance study ------------------------------------------------------------------------------- 50 
Procedure for follow-up with participants after termination of the clinical performance study ----------------------------------- 51 
7.9 
STUDY DURATION AND FLOWCHART. -------------------------------------------------------------------------------------------------------- 51 
8 
SAFETY ---------------------------------------------------------------------------------------------------------------------------------------------- 53 
8.1 
TERMS AND DEFINITIONS --------------------------------------------------------------------------------------------------------------------- 53 
8.2 
EXPECTED ADVERSE EVENTS AND MITIGATION PLANS ------------------------------------------------------------------------------------- 54 
8.3 
SOLICITED ADVERSE EVENTS ----------------------------------------------------------------------------------------------------------------- 54 
8.4 
CATEGORIZATION AND ASSESSMENT OF ADVERSE EVENTS -------------------------------------------------------------------------------- 54 
Casual relationships of SAE --------------------------------------------------------------------------------------------------------------------------- 54 
Adverse events categorization ----------------------------------------------------------------------------------------------------------------------- 54 
Adverse events severity grading --------------------------------------------------------------------------------------------------------------------- 54 
8.5 
DOCUMENTATION AND REPORTING --------------------------------------------------------------------------------------------------------- 55 
Documentation and reporting responsibilities of the PI --------------------------------------------------------------------------------------- 55 
Documentation and reporting responsibilities of Sponsor------------------------------------------------------------------------------------ 55 
Medical management of SAEs and SADEs -------------------------------------------------------------------------------------------------------- 56 
Time period to collecting SAEs information ------------------------------------------------------------------------------------------------------ 56 
Follow up of SAEs and SADEs ------------------------------------------------------------------------------------------------------------------------- 56 
Expedited and annual reporting to the Competent Ethics Committee and Competent Authority --------------------------------- 56 
8.6 
DATA MANAGEMENT SYSTEM ---------------------------------------------------------------------------------------------------------------- 57 
Data review and database cleaning ---------------------------------------------------------------------------------------------------------------- 57 
Data verification ----------------------------------------------------------------------------------------------------------------------------------------- 57 
Data analysing and archiving ------------------------------------------------------------------------------------------------------------------------ 57 
Data quality assurance --------------------------------------------------------------------------------------------------------------------------------- 58 
9 
STATISTICAL METHODS ------------------------------------------------------------------------------------------------------------------------ 58 
9.1 
DETERMINATION OF SAMPLE SIZE ------------------------------------------------------------------------------------------------------------ 58 
9.2 
STATISTICAL ANALYSIS PLAN ----------------------------------------------------------------------------------------------------------------- 58 
Populations for analyses ------------------------------------------------------------------------------------------------------------------------------- 58 
General Methodology ---------------------------------------------------------------------------------------------------------------------------------- 59 
Primary outcome analysis ----------------------------------------------------------------------------------------------------------------------------- 60 
Secondary outcomes analyses ----------------------------------------------------------------------------------------------------------------------- 60 
Subgroup analyses -------------------------------------------------------------------------------------------------------------------------------------- 61 
Descriptive Statistics ------------------------------------------------------------------------------------------------------------------------------------ 61 

 
 
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Safety Analyses 61 
Additional Analyses ------------------------------------------------------------------------------------------------------------------------------------- 61 
Missing data 
61 
Statistical software-------------------------------------------------------------------------------------------------------------------------------------- 61 
10 
QUALITY ASSURANCE AND REGULATORY ASPECTS ----------------------------------------------------------------------------------- 62 
10.1 
QUALITY ASSURANCE AND CONTROL --------------------------------------------------------------------------------------------------------- 62 
Study documentation ----------------------------------------------------------------------------------------------------------------------------------- 62 
Case Report Forms -------------------------------------------------------------------------------------------------------------------------------------- 63 
Storage of biological material and related health data --------------------------------------------------------------------------------------- 63 
Archiving of essential clinical investigation documents --------------------------------------------------------------------------------------- 63 
10.2 
MONITORING AND MONITORING PLAN ------------------------------------------------------------------------------------------------------ 63 
10.3 
AUDITS AND INSPECTIONS -------------------------------------------------------------------------------------------------------------------- 63 
10.4 
REGULATORY ASPECTS ------------------------------------------------------------------------------------------------------------------------ 64 
Clinical Performance Study Plan amendments -------------------------------------------------------------------------------------------------- 64 
Deviation from the Clinical Performance Study Plan ------------------------------------------------------------------------------------------- 64 
11 
CONFIDENTIALITY AND DATA PROTECTION --------------------------------------------------------------------------------------------- 64 
12 
PUBLICATION AND COMMUNICATION ---------------------------------------------------------------------------------------------------- 64 
13 
FUNDING AND SUPPORT ---------------------------------------------------------------------------------------------------------------------- 65 
13.1 
FUNDING -------------------------------------------------------------------------------------------------------------------------------------- 65 
14 
INSURANCE ---------------------------------------------------------------------------------------------------------------------------------------- 65 
15 
REFERENCES --------------------------------------------------------------------------------------------------------------------------------------- 65 
 
 
 
 
 

 
 
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 SYNOPSIS 
Title: 
Evaluation of performance, acceptability and usability of a novel Lateral Flow Assay 
(LFA) for point-of-care (POC) detection of Neisseria gonorrhoeae (NG) infection among 
pregnant and symptomatic women in South Africa.  
Short title / Study ID: 
GO SA   
CPSP, version and date: 
Version 1.1 15/04/2025 
Registration: 
clinicaltrials.gov  
Sponsor  
FPD  
Intervention: 
Non-interventional   
Name of the IVD device 
FIND developed prototype NG LFA and NG LFA reader   
Reader Software version – FIND-Reader-beta-1.2.1 
Stage of development: 
Design frozen IVD 
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.  

 
 
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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. 
Objective(s): 
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. 
Outcome(s) / endpoint(s) Primary endpoints – 
 
1. Point estimates of sensitivity and specificity with 95% confidence intervals 
(Wilson’s score method) among pregnant ANC attendees.  
Secondary endpoints -  
2. Point estimates of sensitivity and specificity with 95% confidence intervals 
(Wilson’s score method) among symptomatic non-pregnant women.  
3. 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.  
4. Point estimates of the percentage differences with 95% confidence intervals 
(Tango’s score method) of the diagnostic performance metrics between self-

 
 
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collected and provider-collected vaginal samples for the detection of NG in non-
pregnant symptomatic women. 
5. 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. 
6. 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.  
7. 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.   
Study Design 
Type and 
Rationale: 
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. This design is appropriate as it allows for a 
direct comparison of the NG LFA's performance to the established gold standard in a real-
world clinical setting. The inclusion of both sample types allows for an evaluation of the 
effect of the collection method on test performance, safety and acceptability.  
Specimen type 
High vaginal swabs (provider collected and self-collected)  
Reference 
device 
Xpert® CT/NG, which is the established gold standard for NG diagnosis on clinician-
collected vaginal samples  
Participants 
Inclusion/exclusion 
criteria: 
ANC population   
Inclusion - 
• 
Women age ≥18 years. 
• 
Pregnant women. 
• 
Attending a study site for antenatal care.    
• 
Willingness to participate and signed informed consent form (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. 
Symptomatic population   
Inclusion - 
• 
Non pregnant women age ≥18 years. 

 
 
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• 
Diagnosis of VDS. Diagnosis of VDS will be based on self-reported presence of 
symptoms 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. 
Healthcare workers 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. 
Measurements and 
procedures: 
 
 
 
 
 
 
 
Three provider-collected and one self-collected swab will be obtained from each study 
participant on day 1 for each of the following procedures -  
Provider-collected: 
1. NG LFA 
2. Xpert® CT/NG 
3. Discordance testing/storage  
Self-collected: 
1. NG LFA 
 
GeneXpert 
NG LFA 
Storage/ Discordance 
Provider-collected   
X  
X  
X  
Self-collected   
  
X  
  
Operational research procedures:  
The Theoretical Framework of Acceptability (TFA) acceptability survey relating to self-
sampling among participants who are undergoing the sampling procedures will be 
administered after the sample collection procedures are completed. 
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).  

 
 
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The TFA acceptability survey among healthcare workers regarding self-sampling will be 
administered to all healthcare workers conducting study-related testing procedures at 
month 3 (the projected mid-point of participant enrolment). 
At month 5, qualitative methods will be conducted among healthcare workers who are 
conducting the study and healthcare workers who work at the clinics where the study is 
taking place.  
Number of participant 
participants/ specimens  
ANC – 778  
Symptomatic – 461 
Operational research: 
All participants undergoing the testing procedure  
All healthcare workers who conduct the NG LFA testing 
12 to 20 healthcare workers at the primary healthcare level who are not conducting the 
NG LFA testing  
Overall study duration 
and duration for the 
individual participants: 
Six months. The study is a cross-sectional study with a single time point. 
Performance study 
schedule: 
 
 
 
 
 
 
 
 
2024 
Jul 
Aug 
Sep 
Oct 
Nov 
Dec 
Study Protocol  
 
 
 
 
 
 
CEC approval 
 
 
 
 
 
 
Staff training 
 
 
 
 
 
 
Recruitment  
 
 
 
 
 
 
Data analysis  
 
 
 
 
 
 
Report 
 
 
 
 
 
 
2025 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
 Sept 
Oct 
Nov 
Dec 
Study Protocol  
 
 
 
 
 
 
 
 
 
 
 
 
CEC approval 
 
 
 
 
 
 
 
 
 
 
 
 
Staff training 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment  
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis  
 
 
 
 
 
 
 
 
 
 
 
 
Report 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator(s) 
Mandisa Mdingi – FPD 
Dr Sarita Naidoo – FPD  
Study Site(s): 
Multicentre performance study in five FPD satellite clinical sites in East London.   
Clinal site locations in East London, South Africa -   
1. Nontyatyambo CHC, 15 Dunga Road, Nu 2, Mdantsane, 5219 
2. Empilweni Gompo CHC, Dunoon Road, East London, 5209 
3. Duncan Village Day Hospital, 24 Phoenix Street, Braelyn, East London, 5201 
4. Grey Gateway Clinic, Lonsdale Road, King William’s Town, 5601 
5. Ndevana Clinic, Ndevana location, Zwelitsha, 5608 

 
 
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Statistical considerations, 
incl. rationale for sample 
size. 
Diagnostic accuracy metrics will be estimated by comparing index test results against 
Xpert® CT/NG results from clinician-collected vaginal samples. Point estimates of 
sensitivity and specificity will be calculated as TP/(TP+FN) and TN/(TN+FP), respectively, 
with 95% CI using Wilson’s Score. Tango’s score method will be used to calculate 95% CIs 
while calculating paired differences. McNemar test will be used to compare 
sensitivities/specificities. 
In the ANC population, to estimate a sensitivity of 80% ±15% and a specificity of 98.1% 
±5%, with alpha 5% and 80% power, 56 confirmed positives and 59 confirmed negatives 
are needed, respectively. To detect a difference <5% between the sensitivity/specificity of 
clinician-collected and self-collected samples with the assumption that the observed 
difference will be 1 % for both sensitivity/specificity, with alpha 5% and power 80%, 39 
positive and 39 negative paired samples are needed. To obtain 56 confirmed positives in 
the population with a prevalence estimate of 8% and a power of 80%, 778 participants are 
needed to be screened. 
In the symptomatic population, to detect a difference <5%, with the assumption that the 
observed difference will be 1.5%, alpha = 5%, power 80%, 76 confirmed positive and 
negative pairs are needed.  With a prevalence estimate of 18% and a power of 80%, 461 
participants must be screened. 
Compliance statement: 
This performance study will be conducted in compliance with the CPSP, the current 
version of the Declaration of Helsinki, the CIOMS International Guidelines for Health 
Research Involving Human Participants, standard ISO 20916: 2019, ICH-GCP (as far as 
applicable), and all national regulatory requirements. 
 
 
 
 

 
 
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ABBREVIATIONS 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
AMR 
Antimicrobial Resistance  
ANC 
Antenatal Care  
ASADE 
Anticipated Serious Adverse Device Effect 
ASR 
Annual Safety Report 
CA 
Competent Authority  
CEC 
Competent Ethics Committee 
CPSP 
Clinical performance study plan 
CPSR 
Clinical performance study report 
CRF 
Case Report Form (pCRF paper CRF; eCRF electronic CRF) 
CT  
Chlamydia Trachomatis 
DD 
Device Deficiency 
DMC / DSMC 
Data Monitoring Committee, Data Safety Monitoring Committee 
FGD 
Focus group discussion 
FPD 
Foundation for Professional Development  
HCW 
Healthcare worker 
Ho, H1 
Null hypothesis, Alternative hypothesis 
ICF 
Informed Consent Form 
ICH-GCP 
International Council for Harmonisation – guidelines of Good Clinical Practice 
IEC 
Independent Ethics Committees 
IFU 
Instructions For Use 
IRB 
Institutional Review Boards 
ISF 
Investigator Site File 
ISO 
International Organisation for Standardisation 
ITT 
Intention to treat 
IVD 
In Vitro Diagnostic 
IVDR 
In Vitro Diagnostic Device Regulation (EU) 2017/746 of 5 April 2017 
MUS 
Male Urethritis Syndrome  
NAAT 
Nucleic Acid Amplification Test 
NG 
Neisseria gonorrhoeae 
NG LFA  
Neisseria gonorrhoeae Lateral Flow Assay  
PI 
Principal Investigator 

 
 
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PMPF 
Post-Market Performance Follow-up 
POC 
Point of Care  
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SDV 
Source Data Verification 
SOP 
Standard Operating Procedure 
TFA 
Theoretical Framework of Acceptability  
STI  
Sexually Transmitted Infection 
USADE 
Unanticipated Serious Adverse Device Effect 
VDS 
Vaginal Discharge Syndrome 
WHO 
World Health Organisation  
 
INVESTIGATION SCHEDULE 
 
 
Study Periods 
Study visit 
Notes 
Visit 
1 
  
Participant information  
X 
  
Participant consent 
X 
  
Demographics  
X 
  
Medical history  
X 
 
Routine genital examination 
X 
Self-collected sample (1) 
X 
High vaginal swab 
Provider-collected sample (3) 
X 
High vaginal swabs  
NG LFA testing 
X 
Xpert® CT/NG testing 
X 
Storage of swab 
X 
Treatment  
X 
Adverse Events  
X 
Routine STI counselling 
X 
Partner notification leaflet   
X 
 
 
 
 
 
 

 
 
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1 
INVESTIGATION ADMINISTRATIVE STRUCTURE 
1.1 
Sponsor 
The Sponsor of this clinical performance study is: 
Foundation for Professional Development (FPD) 
1.2 
Principal Investigator(s) and Study site(s) 
Mandisa Mdingi 
Research Manager, Foundation for Professional Development (FPD), East London Office, 16 Surrey Road, Vincent, East 
London, South Africa 
mandisam@foundation.co.za  
 
Clinical site locations in East London, South Africa -   
1. Nontyatyambo CHC, 15 Dunga Road, Nu 2, Mdantsane, 5219 
2. Empilweni Gompo CHC, Dunoon Road, East London, 5209 
3. Duncan Village Day Hospital, 24 Phoenix Street, Braelyn, East London, 5201 
4. Grey Gateway Clinic, Lonsdale Road, King William’s Town, 5601 
5. Ndevana Clinic, Ndevana location, Zwelitsha, 5608 
1.3 
Biostatistician 
The following statistician/biostatistician will be involved in the clinical performance study: 
 
Mikaela Watson, Associate, Biostatistician, FIND, Chem. du Pommier 40, 1218 Le Grand-Saconnex, Geneva, Switzerland 
mikaela.watson@finddx.org 
1.4 
Medical oversight 
Dr Ranjana Gigi, Physician, Foundation for Professional Development (FPD), East London Office, 16 Surrey Road, Vincent, 
East London, South Africa 
ranjanag@foundation.co.za  
1.5 
Laboratory (for discordance testing)  
The following laboratories will be involved in the clinical performance study: 
 
Dr. Hyunsul Jung, Prinshof Campus, Department of Medical Microbiology, Faculty of Health Sciences, University of Pretoria. 
wjdgustmf@gmail.com 
1.6 
Monitoring institution 
Clinical Trials Unit, Clinical Affairs, FIND, Chem. du Pommier 40, 1218 Le Grand-Saconnex, Geneva, Switzerland 
1.7 
Data Safety Monitoring Committee and the Trial Steering Committee 
This protocol, originally developed by FIND, outlines the procedures for evaluating the performance, acceptability and 
usability of a novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection among pregnant and 

 
 
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symptomatic non-pregnant women in South Africa. While FIND initiated the study design and protocol development, 
sponsorship has been transferred to FPD. This transition entails a complete handover of responsibilities, including ethical 
oversight, data management, and regulatory compliance.  FIND will provide strategic oversight and guidance on trial-
related issues by participating in the Trial Steering Committee (TSC) and Data and Safety Monitoring Board (DSMB). 
 
The TSC will ensure the trial is conducted according to the protocol, contractual agreements, and applicable regulatory 
standards, including ICH-GCP and local regulations. The TSC will monitor trial progress, including recruitment, data 
collection, and analysis and will be responsible for reviewing and endorsing any proposed protocol amendments or 
changes in trial procedures. Additionally, the TSC will review results and provide guidance on the continuation, 
modification, and termination of the trial. It will also oversee the dissemination and publication of results. The TSC will 
comprise representatives from FIND, Sponsor, Investigators, statisticians, and independent experts. A charter outlining 
the TSC’s roles, responsibilities, frequency of meetings, decision-making processes, and other key elements will be 
developed to ensure effective governance and oversight. 
 
 An independent DSMB will be established to protect the safety and well-being of study participants. The DSMB will 
operate independently of the Sponsor-Investigator and study teams, following a formal charter outlining its 
roles, responsibilities, and operating procedures. The DSMB will review accumulating study data for any safety 
concerns, monitor study conduct and progress, and ensure data quality and integrity. Based on its reviews, the DSMB 
may make recommendations to the TSC regarding the continuation, modification, or early termination of the 
trial, particularly regarding safety concerns or lack of efficacy (futility). 
 
2 
BACKGROUND AND RATIONALE 
2.1 
Background and rationale of the clinical performance study 
The World Health Organization (WHO) estimates that over 80 million new gonococcal infections occur annually, with a 
disproportionate burden occurring in low- and middle-income countries2. Untreated gonorrhoea, which is now becoming 
more resistant to antibiotics, can lead to adverse maternal and neonatal outcomes2. Current diagnosis relies on NAATs 
like Xpert® CT/NG, which are sensitive and specific but expensive, require specialised equipment with a long turnaround 
time, and may not be readily available in resource-limited settings, particularly in primary healthcare facilities and ANC 
clinics. This lack of access has resulted in a reliance on syndromic management, leading to both over-treatment and 
undertreatment and consequently contributing to the spread of infection and the rise in AMR.  
 
There is a pressing need for point-of-care (POC) tests for NG that are accurate, affordable, easy to use, and suitable for 
decentralised settings. POC tests would enable a shift from syndromic to etiological testing, allowing for correct diagnosis 
of NG and timely treatment initiation, potentially lowering transmission rates and improving patient outcomes. By 
providing rapid and accurate results at the point of care, these tests may enable prompt and appropriate treatment of 
infected women, reducing the duration of infection and curbing transmission rates1. 
 
Previous FIND-led NG LFA performance studies have shown promising results, with a sensitivity of 80% in asymptomatic 
women in East London (unpublished, Remco et al 2023). However, a study in Zimbabwe found a lower sensitivity of 65% 
among pregnant women attending ANC (unpublished, Martin et al 2023). This discrepancy raises questions about the 
LFA's performance in this specific population and setting. The observed difference in sensitivity between asymptomatic 
non-pregnant women and pregnant women highlights the need to investigate the LFA's performance, specifically in the 

 
 
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ANC population. It has been hypothesised that pregnancy may induce physiological changes affecting the test's accuracy. 
Therefore, further investigation is needed to confirm this potential impact. 
 
This main research question is to determine if the NG LFA can accurately detect NG in vaginal samples collected from 
pregnant women attending ANC and non-pregnant symptomatic women and to determine if there is a difference in 
performance between self-collected and provider-collected samples. This study employs a cross-sectional design, 
comparing the NG LFA results to the Xpert® CT/NG reference standard in vaginal samples collected from women 
attending ANC and non-pregnant symptomatic women. This design is appropriate for assessing the diagnostic accuracy 
of the NG LFA in a real-world clinical setting. The inclusion of both self-collected and provider-collected samples allows 
for the evaluation of the impact of sample collection method on test performance and acceptability. This is important for 
understanding self-collection's feasibility, safety and potential benefits in expanding access to NG testing. 
 
3 
CLINICAL PERFORMANCE STUDY OBJECTIVES AND OUTCOMES (ENDPOINTS) 
3.1 
Study Objectives 
This performance study aims to evaluate the diagnostic accuracy, acceptability, and user preference of the NG LFA for 
detecting NG in vaginal samples compared to the Xpert® CT/NG reference standard. The study will assess the 
performance of the NG LFA in both self-collected and provider-collected samples from pregnant women attending ANC 
and non-pregnant symptomatic women. By determining the accuracy and usability of the NG LFA, this study will inform 
decision-making regarding its potential adoption as a POC test for NG in resource-limited settings. Additionally, the study 
will assess the safety of self-collection of high-vaginal swabs for testing of NG. This will inform the future adoption of self-
testing in routine practice. 
Primary Objective 
1. To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples 
from pregnant women attending ANC when compared to Xpert® CT/NG as the reference standard.   
Secondary Objective(s) 
2. To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples 
among non-pregnant symptomatic 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 non-pregnant symptomatic women.   
5. To compare the safety of self-collection of vaginal swabs vs provider collection among pregnant women attending 
ANC and non-pregnant symptomatic 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 ANC attendees and symptomatic women and healthcare workers.  

 
 
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3.2 
Study Outcomes (Endpoints) 
Claims and Intended Performance of the NG LFA: 
The NG LFA is a POC test designed to rapidly and accurately detect NG infection in male urine and female vaginal swabs. 
It aims to facilitate early diagnosis and treatment of NG infections, particularly in resource-limited settings. The device 
intends to be accurate, easy to use, and acceptable for self-collection and provider-collection samples. 
 
Risks and Anticipated Adverse Device Effects: 
As this study involves the use of a non-invasive diagnostic test, there are no specific safety objectives related to the use 
of NG LFA, which is a POC test. Treatment decisions will not be made according to the device under investigation and 
results will be collected for research purposes only. Collection of swab samples from study participants is minimally 
invasive and poses a low risk. Adverse effects associated with the collection of swabs could include discomfort or 
irritation during sample collection. Given the nature of the study, termination due to safety or other reasons is not 
anticipated. 
 
Primary Outcome 
1. Point estimates of sensitivity and specificity with 95% confidence intervals (Wilson’s score method) among 
pregnant ANC attendees.  
Secondary Outcome(s) 
2. Point estimates of sensitivity and specificity with 95% confidence intervals (Wilson’s score method) among 
symptomatic non-pregnant women.  
3. 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.  
4.  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. 
5. 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 symptomatic non-pregnant women. 
6. 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.  
7. Mixed methods: Distribution of acceptability questionnaire score, perceptions on acceptability and preference 
from qualitative focus group discussions.  Proportion of participants in each group who prefer self-collected 
samples over provider-collected samples.   
Safety Outcome(s) 
Any discomfort reported by participants during sample collection will be documented. Although the NG LFA and sample 
collection are considered of negligible risk, monitoring for any potential effects is essential to ensure participant safety. 
The safety of self-collection of high vaginal swab samples will be assessed as per secondary objective four above. 

 
 
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4 
DESIGN OF THE CLINICAL PERFORMANCE STUDY 
4.1 
Study Design 
This is a cross-sectional 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 in pregnant women attending ANC and to compare the 
accuracy of self-collected and provider-collected samples in both symptomatic non-pregnant women and pregnant ANC 
attendees. This design is appropriate as it allows for a direct comparison of the NG LFA's performance to the established 
gold standard in a real-world clinical setting. The inclusion of both sample types allows for an evaluation of the effect of 
the collection method on test performance and acceptability.  
Justification for choice of the study population 
This study will recruit pregnant women attending ANC and non-pregnant symptomatic women attending clinics for 
suspected STIs. These populations are at elevated risk for NG infection in South Africa and represent the target use case 
of the NG LFA in clinical practice. Approximately 57% of NG infections in women in South Africa are asymptomatic3. 
Without screening, these cases of NG infection can be left untreated. 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. Efforts will be made to recruit a diverse 
sample of participants to ensure the study population is representative of the target population. Gender balance is not 
applicable as the study only focuses on female NG infection. 
Inclusion and exclusion criteria for participants providing specimens. 
ANC population   
Inclusion - 
• 
Women age ≥18 years. 
• 
Pregnant women. 
• 
Attending a study site for antenatal care.    
• 
Willingness to participate and signed informed consent form (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. 
Symptomatic population   
Inclusion - 
• 
Non pregnant women age ≥18 years. 
• 
Diagnosis of VDS. Diagnosis of VDS will be based on self-reported presence of symptoms consistent with VDS, 
such as increased or abnormal vaginal discharge. 
• 
Willingness to participate and signed ICF.  
Exclusion -  

 
 
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• 
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. 
Healthcare workers population  
Systems Usability Score Survey & TFA Acceptability Survey 
• 
HCWs manipulating 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. 
Justification for selection of study specimens 
Vaginal swabs are the recommended sample type for NG testing in women and are easily obtainable through both self- 
and provider-collection methods. To date, the NG LFA has been validated for testing with female vaginal swabs and male 
urine only. Three provider-collected and one self-collected high vaginal swab will be collected from each participant. 
Study sites will record the required information for all collected swabs in a study sample log. The detailed specimen 
collection procedure for both self-collected and provider-collected samples is described in section 7.6. 
Justification for the use of specimens collected specifically for the study purposes 
The collection of new specimens is essential for this study due to several reasons: 
1. Previous lab validation studies conducted by the developer, DCN, have indicated that using frozen samples for 
performance testing is unsuitable for the NG LFA. This practice has been shown to impact the sensitivity and 
specificity of the test negatively. The primary reason for this is believed to be the disruption of the vaginal 
matrix caused by the freezing process. 
2. A key aspect of this study is evaluating the feasibility and accuracy of self-collected samples. New samples are 
required to compare self-collected and provider-collected specimens directly, ensuring a robust assessment of 
alternative collection methods. 
3. The collection of new samples allows for establishing a biobank, which can be used for future research and 
development, such as developing a dual LFA for both chlamydia trachomatis and NG. This could have significant 
implications for improving the diagnosis and treatment of STIs globally. 
4.2 
Reference methods 
Gold Standard(s) method(s) 
The Xpert® CT/NG assay will be used as the gold standard reference method due to its high sensitivity and specificity for 
detecting NG in vaginal samples. The Xpert® CT/NG has been validated and widely used in clinical settings to diagnose NG 
infection. It is considered the best practice current standard of care for NG diagnosis due to its superior performance 
compared to other non-molecular based methods or syndromic management. 

 
 
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Routine Diagnostic method(s) (if applicable) 
The study focuses on evaluating the NG LFA against the gold-standard Xpert® CT/NG rather than comparing it to existing 
routine diagnostic methods. In most low-resource settings, no diagnostics are available, and patients are treated 
according to a WHO-endorsed syndromic management approach.  
4.3 
Analytical Performance of NG LFA 
The observed limit of detection with reference NG strains of the NG LFA was 5 × 103 CFU/ml. Inclusivity was 
demonstrated for 31 NG strains. Exclusivity testing showed no cross-reactivity with 28 non-Neisseria and 
nongonococcal Neisseria species; cross-reactivity was observed with Neisseria meningitidis, Neisseria lactamica, 
and Neisseria polysaccharea4. 
4.4 
Clinical Performance 
To date, three FIND-led clinical performance studies have been conducted (1 published and 2 unpublished). 
 
1. Symptomatic study, East london1 
 
Male Patients (n=200) 
Female Patients (n=200) 
NG prevalence 
128 (64%) 
36 (18%) 
Sensitivity 
96·1% (91·2– 98·3) 
91·7% (78·2–97·1) 
Specificity 
97·2% (90·4–99·2) 
96·3% (92·2–98·3) 
 
2. Asymptomatic study, East London (unpublished, Peters et al., 2023) 
  
Males (n=500)  
Females (n=400)  
NG prevalence  
6.2%  
8.3%  
Sensitivity  
80.6% (63.7% - 90.8%)  
81.8% (65.6% - 91.4%)  
Specificity  
94.2% (91.8% - 96.0%)  
98.1% (96.1% - 99.1%)  
 
3. ANC study, Zimbabwe (Unpublished, Martin et al., 2023) 
Variable 
Sensitivity % (n/N) 
95% CI 
Specificity % (n/N) 
95% CI 
Overall 
65·8% (25/38) 
48·6 - 80·4% 
99·2% (867/874) 
98·4 – 99·7% 
 
Clinical claims and intended clinical IVD device performance to be evaluated 
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. 

 
 
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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. 
Parameters of clinical performance to be determined 
The primary parameters of clinical performance to be determined in this study include: 
• 
Sensitivity: The proportion of true NG-positive samples correctly identified by the NG LFA. 
• 
Specificity: The proportion of true NG-negative samples correctly identified by the NG LFA. 
• 
Positive Predictive Value (PPV): The probability that a positive NG LFA result truly indicates NG infection. 
• 
Negative Predictive Value (NPV): The probability that a negative NG LFA result truly indicates the absence of NG 
infection. 
Justification for chosen of clinical performance parameters 
The chosen clinical performance parameters are essential for assessing the diagnostic accuracy of the NG LFA in the 
target population. Sensitivity and specificity are key test performance measures, indicating its ability to identify infected 
and uninfected individuals correctly. PPV and NPV provide valuable information about the likelihood of a positive or 
negative test result accurately reflecting the true infection status. Determining these clinical performance parameters 
will have significant implications for individual health and public health management decisions. A highly sensitive and 
specific POC test like the NG LFA could enable rapid diagnosis and treatment of NG infection, potentially reducing 
transmission rates, improving patient outcomes, and mitigating the development of AMR. Furthermore, accurately 
identifying NG-infected individuals can help guide appropriate treatment decisions and prevent unnecessary antibiotic 
use. By establishing the clinical performance of the NG LFA in both self-collected and provider-collected samples from 
non-pregnant symptomatic women and pregnant women attending ANC, this study will provide valuable evidence to 
inform decision-making regarding its potential implementation as a POC test for NG in resource-limited settings. 
5 
IDENTIFICATION OF THE IVD DEVICE UNDER INVESTIGATION 
5.1 
Summary description of the IVD device under investigation 
Item  
Description 
Manufacturer/Developer 
DCN (Designed frozen RUO IVD – currently undergoing transfer to a manufacturer) 
Manufacturer SRN Number 
NA. DCN are a contract research organisation, not a manufacturer 
Device identification and 
labels 
The NG LFA device will be labelled with a unique identifier, including a lot number 
expiration date and clear instructions on the packaging that the device is for research 
use only. 
Device traceability 
Each NG LFA device will be traceable through a unique lot number linked to 
manufacturing records. 
List of technical and 
functional features of the 
device 
The NG LFA is a rapid, qualitative immunoassay that detects NG-specific antigens in 
female vaginal swabs and male urine specimens. The test is based on the lateral flow 
principle, where the sample migrates along a nitrocellulose strip containing capture 
antibodies specific for NG antigens. A result is interpreted by the presence or 
absence of a fluorescently labelled test line detected by a fluorescent reader. 
Device analyte 
Neisseria gonorrhoeae (NG) specific antigens. 
Type of specimen 
Male urine or vaginal swab. Only vaginal swabs will be evaluated in the current study.  
Specimen handling and 
storage condition 
Vaginal swab specimens should be collected using NG LFA-specific swabs and should 
be tested immediately by being placed into the provided buffer solution. 
Intended use 
Detection of NG in male urine or female vaginal swabs. 

 
 
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Intended clinical benefit 
Rapid identification of NG infection at the point of care, timely initiation of 
appropriate treatment, potential reduction in transmission rates, and improved 
patient outcomes.  
Intended users 
Healthcare providers (e.g., doctors, nurses, midwives, healthcare assistants) trained 
in the collection of vaginal swab specimens and the interpretation of LFA results. 
Intended use environment 
Point-of-care settings include primary healthcare facilities, sexual health clinics, and 
ANC clinics. 
Target population 
Non-pregnant symptomatic women presenting with symptoms of vaginal discharge 
syndrome. Pregnant women attending ANC. 
Indications 
Suspected NG infection based on clinical symptoms or risk factors. Routine screening 
for NG infection in pregnant women. 
Contraindications 
None known 
IVD device accessories 
Vaginal swab 
Buffer solution 
Positive and negative controls 
Sample tube and dropper top 
Medicine dropper 
NG LFA  
NG LFA Fluorescent reader 
Timer and power source (not included) 
IVD device software (Reader) 
FIND-Reader-beta-1.2.1 
IVD device mode of use 
The NG LFA is a single-use, disposable device. 
IVD device calibration 
No calibration is required. Positive and negative controls should be used daily before 
testing on study participants. 
IVD device handling and 
storage condition 
The NG LFA and buffer should be stored at room temperature in their sealed pouch 
until use. The reader should also be stored at room temperature. The device should 
not be used after the expiration date. Stability testing of the NG LFA demonstrated 
that the NG LFA test signal remained stable at 40°C/70% relative humidity for 575 days 
(19 months) of real-time stability and at 2-8°C and 55°C for 70 days for accelerated 
stability testing.  
Training and experience 
requirements 
Users should be healthcare providers trained in the collection of vaginal swab 
specimens and interpretation of LFA results. 
 
6 
ETHICAL ASPECTS AND RISK EVALUATION 
6.1 
Ethical aspects 
Registration of the investigation 
After receiving ethical approval, this performance study will be registered on clinicaltrials.gov. 
Competent Ethics Committee (CEC) 
The PI submits the CPSP, the ICF, participants’ recruitment procedures and any other information provided to participants, 
the PI’s Curriculum Vitae to the CEC, and obtains ethical committee approval before the start of the performance study. 
The PI ensures that a copy of the final CEC approval letter is received, shared with the Sponsor, and filed in the 
Investigator’s file & Sponsor Trial Master File before the performance study starts. 

 
 
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Reporting duties to the Competent Ethics Committee (CEC) 
No changes will be made to the CPSP without prior Sponsor and CEC approval, except where necessary to eliminate 
apparent immediate hazards to participants. Refer to Chapter 8 for safety reporting. 
Progress reports will be submitted to the Ethics Committee at the end of each year from the commencement. The Annual 
progress report form is available from the ethics website. 
All serious adverse events will be reported to the CEC within 72 hours of first knowledge of the event.  All protocol 
violations, protocol deviations and minor GCP violations will be reported to the EC as soon as the PI becomes aware of the 
violation. The PI will notify the CEC if the study is prematurely suspended or terminated. A summary will be sent to the 
CEC outlining the reasons for the suspension or termination before the anticipated termination date. The suspension or 
premature termination of the performance study will be reported to the CEC within 24 hours if due to safety reasons. The 
reasons for the study suspension or premature termination must be given. 
A final report is submitted to the CEC within one year after the regular end of the performance study and within three 
months after a premature termination of the performance study. Competent Authorities (CA) approval is required. The 
report will also be submitted to the SA regulatory authorities. The study design and procedures will be submitted parallel 
to the relevant ethics committees , ensuring the protection of participants' rights and safety. 
Reporting duties to the Competent Authorities (CA) 
The study will be registered with the South African Health Products Regulatory Authority (SAHPRA), and a six-monthly 
progress report will be submitted following approvals. All serious adverse events (fatal or life-threatening related and 
unexpected) will be reported to SAHPRA within seven days of the PI's first knowledge. Other serious adverse reactions 
(unexpected, not fatal or life-threatening) will be reported within 15 calendar days of the PI's first knowledge of the event. 
 
Ethical conduct of the investigation 
The performance study will be carried out according to the CPSP and with principles enunciated in the current version of 
the Declaration of Helsinki, the CIOMS International Guidelines for Health Research Involving Human Participants, standard 
ISO 20916, ISO 14971, ICH-GCP as far as applicable, and South Africa’s regulatory authority’s requirements.  
Declaration of Interests 
The Sponsor and all Investigators involved in this performance study declare that they have no financial, intellectual, or 
other personal interests that could unduly influence their professional judgment or compromise the integrity of this 
research. 
Patient Information and Informed Consent 
1. The PI or its designee explains to each potential participant the nature of the performance study, its purpose, the 
procedures involved, the expected duration, the potential risks and benefits and any burden and discomfort it 
may entail in a language the participant best understands.   
2. Each participant will be informed that participation in the performance study is voluntary, that she may withdraw 
from the performance study at any time, and that withdrawal of consent will not affect her subsequent medical 
assistance and treatment. The participants are also informed that authorised individuals other than their treating 
physician may examine their medical records. 
3. When applicable, the participants will be informed that their personal physicians may be informed, with their 
approval, about their participation in the performance study. 
4. All participants will be given a study information sheet and an ICF describing the performance study and 
providing sufficient information for the participants to make an informed decision about their participation in 
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5. Participants will be informed that they can ask any question and consult with family members, friends, their 
treating physicians, or other experts before deciding to participate in the performance study. Enough time for 
reflection will be given to the participants.  
6. A participant's formal consent is obtained before the participant undergoes any study procedure, using the ICF 
approved by the CEC.  
7. The consent form will be signed and dated by the participant and the PI or her/his designee who obtained the 
informed consent.  
8. The participant should read, understand, and voluntarily agree before signing and dating the ICF; the participant 
is given a copy of the signed document. The signed consent form is retained as part of the performance study 
documents.  
9. Participants who cannot read or write will choose an impartial witness to attend the informed consent sessions 
and sign on behalf of the participant. 
10. The participant’s medical records are clearly marked to indicate that the participant is enrolled in the performance 
study. 
11. The participant is provided with well-defined procedures for possible emergencies related to the performance 
study. The PI makes the necessary arrangements for emergency treatment.  
12. Should individuals decide not to participate in the study, we will ensure they receive the standard treatment like 
anyone presenting with STI-associated symptoms.  
13. Participants will be compensated with a voucher of R100 for the local grocery store (e.g. Shoprite, Spar, Checkers) 
for the time associated with their participation in the study. 
Participant privacy and confidentiality 
The Sponsor and the PI affirm and uphold the principle of the participant’s right to privacy and that they shall comply with 
applicable privacy laws. The anonymity of the participants shall be guaranteed when presenting the data at scientific 
meetings or publishing them in scientific journals. Individual participant medical information obtained from this 
performance study is confidential, and disclosure to third parties is prohibited. Confidentiality will be guaranteed by 
assigning a unique participant identification number to each individual enrolled in the study. This unique identifier will 
replace any direct personal identifiers (such as names or addresses) in all study-related documentation and databases. The 
unique identification number will be generated using a secure, alphanumeric system that ensures no connection can be 
made to the participant's personal information. This system will be managed by authorised study personnel only, and 
access to the code linking identifiers to personal data will be strictly controlled. Study documentation is stored in a secure 
room in a lockable cabinet. Participant registers will be kept in a separate cabinet from any study data (e.g. laboratory 
results). All digital platforms are password protected; these passwords differ from those used to access the device (tablet, 
laptop). Research data can only be accessed by the appropriate research team members. No other individuals will be able 
or allowed to access data. For data verification purposes, authorised representatives of the Sponsor, the CA or a CEC may 
require direct access to parts of the medical records relevant to the performance study, including participants’ medical 
history. 
Dissemination of study findings and post-study access 
The findings of this study will be shared through various channels to ensure they reach relevant audiences: 
1. Scientific Publication: The results will be submitted for publication in peer-reviewed scientific journals to 
contribute to the broader knowledge base. 
2. Conference Presentations: Findings may be presented at relevant scientific conferences to facilitate discussion 
and exchange of ideas among researchers. 
3. Reports to Stakeholders: Study sponsors, funding agencies, and other relevant stakeholders will receive 
comprehensive reports detailing the research's outcomes and implications. 

 
 
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4. Public Dissemination: Depending on the nature of the findings, efforts may be made to share results with the 
public through press releases, media interviews, or accessible summaries. 
 
All study data will be securely archived and de-identified to protect participant confidentiality. Anonymised data may be 
made available to other qualified researchers upon reasonable request and participants to appropriate ethical and legal 
considerations. Strict measures will be taken to ensure that no personally identifiable information is shared during the 
dissemination or data-sharing process. By disseminating findings and providing access to data, we aim to maximise the 
impact of this research and contribute to advancements in the relevant field. 
Community engagement 
FPD has a longstanding relationship with the South African Department of Health at the national, provincial, and district 
levels. Research projects are leveraged to conduct training and capacity-building activities supporting the district's 
service delivery and systems strengthening. FPD works closely with an extensive network of local stakeholders, non-
governmental organisations, and community partners. Community advisory boards are in place to ensure that projects 
are designed and implemented in a locally relevant and culturally appropriate way. Quarterly reports are shared at the 
provincial and district levels. After the study, results will be shared with the stakeholders and local research organisations 
at the community level. 
6.2 
Risk evaluation 
The proposed study evaluating the performance of the NG LFA for detecting NG infection among pregnant and 
symptomatic non-pregnant women presents a low overall risk profile. The procedures involved, primarily the collection 
of vaginal swabs, are routine in clinical practice and carry minimal physical discomfort. However, certain aspects warrant 
consideration. 
1. The diagnosis of an STI, like gonorrhoea, may cause anxiety or stress. Measures will be in place to offer support 
and counselling to participants who require it. Routine counselling about STIs, including the occurrence and 
implications of asymptomatic infections, as well as condom use and safe sex, will be provided by the study 
team. 
2. Considering confidentially concerns regarding STIs, strict data handling and anonymisation protocols will be 
followed to protect participant privacy. 
3. Self-collected samples may introduce variability in specimen quality, potentially affecting test accuracy. 
Participants will receive clear instructions and training. 
4. We understand that in some communities, STIs can be associated with social stigma. We are fully committed to 
ensuring that participants in this study do not experience any form of discrimination or judgement due to their 
involvement. To achieve this, we will implement several key measures: 
a. Participant confidentiality will be maintained at the highest level throughout the study. All data 
collected will be de-identified and handled in accordance with strict data protection regulations. 
b.  Participants will be assigned unique identifiers, ensuring their anonymity in any data analysis or 
reporting. 
c. 
c. All interactions with participants will be respectful and nonjudgmental, emphasising the importance 
of their health and well-being. 
d. Participants will receive comprehensive information about the study, including its purpose, procedures, 
and potential risks and benefits. This will empower them to make informed decisions about their 
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e.  We will provide access to support and counselling services for participants who may experience any 
emotional distress concerns or relationship challenges, such as separation or partner violence, which 
may be related to their participation or STI diagnosis. 
Anticipated clinical benefits  
The NG LFA, if proven effective, has the potential to deliver substantial clinical benefits and positive diagnostic impact for 
patients, particularly in resource-constrained settings: 
 
• 
The rapid, POC nature of the NG LFA enables prompt identification of NG infections. This facilitates early 
intervention and targeted treatment, reducing the risk of complications, onward transmission, and the 
development of AMR 
• 
The NG LFA's ability to provide a definitive diagnosis of gonorrhoea allows for a shift away from syndromic 
management, which relies on symptom-based treatment. This targeted approach ensures that patients receive 
the most appropriate antibiotics, promoting better treatment outcomes and reducing the unnecessary use of 
broad-spectrum antibiotics, a key driver of AMR. 
• 
The LFA's simplicity and portability make it suitable in various healthcare settings, including remote or 
underserved areas. This can significantly increase access to testing for vulnerable populations, such as pregnant 
women and those in rural communities. 
• 
Early detection and appropriate treatment of gonorrhoea contribute to reducing the overall disease burden in 
the community and curbing the spread of AMR. This can prevent serious complications like pelvic inflammatory 
disease, infertility, and adverse pregnancy outcomes, while also safeguarding the effectiveness of existing 
antibiotics. 
• 
The study's exploration of self-collected samples could further expand access to testing and empower 
individuals to take control of their sexual health, potentially leading to earlier detection and treatment. 
 
Anticipated risks  
Expected risks associated with IVD device use  
Based on the nature of the NG LFA and the procedures involved, the anticipated adverse device effects are expected to 
be minimal. 
 
It is important to note that the study team will closely monitor participants for any adverse events and provide 
appropriate care and support if needed. Discomfort or minor pain may occur during the vaginal swab collection process. 
Although the procedure is minimally invasive, some individuals may experience slight discomfort. 
1. Anxiety or stress associated with undergoing testing for STI might be a potential psychological risk. 
2. Potential for stigma or discrimination associated with STIs, although the study will take measures to protect 
participant confidentiality and provide support. 
Expected risks associated with clinical performance study 
Based on previous similar studies, the risks associated with this study are minimal 5 1. Risks associated with self-collection 
of high vaginal swabs in pregnant and non-pregnant women are minimal as self-collection is generally a low-risk 
procedure and is widely used in some countries like the UK. However, the following risks have been identified. 

 
 
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• 
Pain and discomfort 
• 
Embarrassment associated with the collection of vaginal specimens 
• 
Relationship issues may arise following a diagnosis of an STI 
Steps to control or mitigate the risks 
Training of research staff  
 
All study research nurses and healthcare providers will receive comprehensive training on self-sampling procedures and 
how to use the NG LFA device and NG LFA reader. Adequate training ensures accurate sample collection, patient safety, 
and comfort. The duration of the training will typically last about half a day and will depend on the experience of the 
research nurses and healthcare providers.  
 
Prior to any procedure-specific training, study protocol training will be provided by the FIND study team.  
Both self-sampling and provider-sampling training will be conducted by experienced clinicians or nurses familiar with 
gynaecological and obstetrical procedures. The training will include in-depth theoretical instruction on sampling 
techniques and demonstrations using visual aids.  Trainees will have the opportunity to practice guiding the procedure 
under supervision and receive feedback.  All study research nurses and healthcare providers will be trained on 
the detection of potential side effects. They will be instructed to report those as per safety reporting requirements (refer 
to section 8 of the protocol).  
 
Experienced FIND staff will provide Training on LFA testing to ensure research staff have the knowledge required to 
perform LFA testing accurately. Training will include the basic principles of the NG LFA and the NG LFA reader, identifying 
test components, and practical hands-on demonstrations and practice of the entire NG LFA testing process and controls. 
Troubleshooting and potential clinical scenarios or errors will also be addressed. 
 
Retraining will be provided if we see errors in LFA testing, deviations from protocol or issues regarding self-sampling 
techniques.  Indicators that could help identify issues include high invalid rates, inconsistent results (unexpectedly high or 
low positivity rates), participant or healthcare provider feedback and study monitoring. Indicators for issues with self-
sampling techniques could be higher rates of side effects reported in those groups with self-collected samples. Self-
sampling kits will contain both pictorial and written instructions to guide participants. 
Results from the NG-LFA will not be used to make clinical management decisions. 
Residual risks associated with clinical performance study 
Some unforeseeable or unforeseen risks may remain even with all mitigation strategies in place. 
Risk-to-Benefit rationale 
Should the NG LFA show high performance, this test would provide a major milestone in addressing the global burden of 
NG infection and combatting the emergence of AMR. At the individual level, participants might benefit from pathogen-
directed therapy, i.e. fewer antibiotics, based on the Xpert® CT/NG test result. Asymptomatic individuals benefit from 
receiving a free STI screen and subsequent treatment with health benefits, if positive, that they would normally not 
receive. Also, it provides an aetiological explanation of their symptoms, allowing for better counselling. Obtaining 
multiple vaginal swabs for STI testing has been shown acceptable and feasible in multiple studies across the world. 
Therefore, weighing the benefits and risks, we believe this study is ethically justifiable.  

 
 
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7 
CLINICAL PERFORMANCE STUDY PROCEDURES  
7.1 
Recruitment of Principal Investigators and Study Sites 
Principal Investigators recruitment procedure 
The PI was selected based on previous experience conducting STI studies in East London, familiarity with NG LFA from 
previous work, and valuable understanding of the context in East London. 
Study Site recruitment procedure 
Potential sites were evaluated based on their capacity to enrol the target study population, availability of necessary 
resources and infrastructure, and previous experience with STI studies, including NG LFA studies. Sites located in East 
London were selected due to the high prevalence of NG and the substantial number of women attending ANC clinics. The 
selected sites will be responsible for implementing the study protocol, collecting data, and ensuring the safety and well-
being of study participants. 
7.2 
Study participants: recruitment, screening, enrolment, withdrawal and discontinuation 
Participant recruitment and screening procedure 
The primary recruitment target population will be women attending ANC clinics and symptomatic non-pregnant women 
presenting at participating healthcare facilities. The study will aim to enrol 1,239 women. Recruitment will be conducted 
over six months. Potential participants will be screened based on their eligibility criteria.  
If enrolment goals are not met within the specified timeframe, the following actions will be considered depending on 
funding available: 
• 
Extending the recruitment period 
• 
Expanding recruitment to additional healthcare facilities 
• 
Implementing targeted recruitment strategies 
Participant enrolment procedure 
Clinic staff and the study team will identify women attending ANC or healthcare clinics who they think will meet the 
eligibility criteria. Research nurses or healthcare providers will approach eligible women, provide information about the 
study, and assess their willingness to participate. Women who express interest will be provided with a detailed 
explanation of the study, including potential risks and benefits. A brief questionnaire will be administered to confirm 
eligibility based on inclusion and exclusion criteria. Written informed consent will be obtained from those willing to 
participate. Enrolment will involve assigning a unique study identification number, collecting baseline demographic and 
clinical data, and providing instructions for sample collection. The nurse will perform a routine genital examination. Both 
self-collected and provider-collected vaginal samples will be obtained from each participant. If the participant is not 
willing to provide a self-collected sample, then provider-collected vaginal samples will be collected and used for 
performance testing and analysis only.   
 

 
 
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Identification of concomitant intervention procedure 
If participants receive concomitant interventions that could potentially interfere with the study results (e.g. interfering 
substances associated with local practices), this information will be documented and considered during data analysis. 
Informed Consent procedure 
The patient will receive full oral and written information about the investigation using their preferred non-technical 
language (English or isiXhosa) and will be given enough time to decide whether to participate. The patient will then sign 
and date the written ICF before entering the investigation. The investigator will maintain the signed ICF in the clinical study 
file. A copy of the written information and the signed ICF will be given to each patient. An investigator or its designee will 
conduct the informed consent process. The person conducting the informed consent process will also sign and date the 
informed consent form. If important new information needs to be provided to the patient, the patient will be informed 
with a written document that the patient will date and sign to confirm he has understood the new information. The written 
information document must be approved by the Ethics Committees beforehand. Should individuals decide not to 
participate in the study, we will ensure they receive the standard treatment like anyone presenting with STI-associated 
symptoms. All participants who consented to the study and participate in the study will be provided with a voucher for 
R100 from the local grocery store (e.g. Shoprite, Spar, Checkers) for their participation. We prefer not to keep cash at the 
research facilities for security reasons.  
Participant compliance with clinical investigation intervention 
The research team will conduct NG LFA testing, not the participants. Therefore, monitoring participant compliance with 
the device's use is not applicable. As the study involves self-collected and provider-collected vaginal samples, compliance 
will be monitored through the return and documentation of sample collection kits and documentation of sample 
collection by the provider. Participants will be provided with clear instructions on how to collect vaginal samples 
correctly and will be encouraged to ask questions if needed. If the participant is not willing to provide a self-collected 
sample, then provider-collected vaginal samples will be collected and used for performance testing and analysis only.   
Participant withdrawal or discontinuation procedure 
Participants are free to withdraw from the study at any time for any reason without any consequences.  
7.3 
Accounting for Participants 
As this is a single-visit study, there is no risk of loss to follow-up. Each participant's visit will be documented, and their 
participation status will be recorded as either: 
• 
Completed: The participant completed all study procedures. 
• 
Withdrew: The participant voluntarily withdrew from the study before completing all procedures. The reason 
for withdrawal will be documented. 
• 
Discontinued: The study PI discontinued the participant's participation for a specific reason (e.g., a medical 
condition). The reason for discontinuation will be documented. 
7.4 
Methods for Minimising Bias 
Study sites are selected from areas with a high prevalence of NG and a substantial number of women attending ANC 
clinics to ensure the study population is representative of the target population. Eligible participants will be enrolled 
consecutively to avoid cherry-picking (selection bias) and ensure a diverse range of participants.  
 

 
 
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• 
Detailed, standardised protocols will be developed and followed for sample collection (self-collected and 
provider-collected) and testing (NG LFA and Xpert® CT/NG). Study personnel involved in sample collection and 
testing will undergo training to ensure procedure consistency and accuracy. 
• 
Discordant results between the NG LFA and Xpert® CT/NG will be shipped to the University of Pretoria for further 
microbiological analysis   
• 
Detailed data on potential confounding factors, such as age, gestational age, presence of symptoms, recent 
antibiotic use, and interfering substances, will be collected and analysed to assess their impact on the study 
results.  
• 
Regular quality control checks will be conducted on the NG LFA and Xpert® CT/NG tests to ensure optimal 
performance. An independent monitor will monitor the study to ensure compliance with the protocol. 
• 
Validated questionnaires will be used to assess the acceptability and usability of the NG LFA as well as the 
acceptability of self-sampling  
7.5 
Handling of the IVD device under investigation 
IVD device labelling procedure 
The NG LFA will be labelled with a study-specific identification number (e.g., batch/lot number), and the outer packaging 
will state that the IVD is “for research use only.”  
IVD device supply procedure 
FIND via DCN will directly ship the required NG LFA test kits to each participating study site. This will be done before the 
start of the study, ensuring that all sites have sufficient tests to begin enrolment and testing of participants.  FIND will 
monitor the usage of NG LFA test kits at each site throughout the study. If a site runs low on kits, FIND will arrange for a 
re-supply to be shipped directly to the site. The re-supply quantity will be determined based on the site's enrolment rate 
and projected testing needs.  
 
Xpert® CT/NG is a commercially available IVD. The study sites will be responsible for procuring their own test cartridges 
and supplies. They will use existing supply chains in South Africa and manage the re-supply of Xpert® CT/NG cartridges 
and supplies through their usual procurement channels. FIND will provide guidance and support as needed to ensure 
adequate availability of the comparator device throughout the study. 
 
Each study site will maintain a detailed inventory log of the NG LFA and Xpert® CT/NG test kits, recording the receipt, 
usage, and remaining stock. This will facilitate re-supply requests and ensure adequate stock availability. All shipping and 
inventory records will be maintained in accordance with the study-specific documentation requirements. 
IVD device storage procedure 
The NG LFA and the Xpert® CT/NG will be stored in a dedicated, secure storage area with limited access within the study 
site. 
 
Specific storage conditions for each device are as follows: 
NG LFA and NG LFA reader should be stored in a cool, dry place away from direct sunlight. Extended stability 
testing has been performed with the NG LFA and buffer. Stability testing of the NG LFA demonstrated that 

 
 
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the NG LFA test signal remained stable at 40°C/70% relative humidity at 575 days (19 months) of real-time stability 
and at 2-8°C and 55°C at 70 days for accelerated stability testing. Stability testing of the reader has not been 
performed. DCN had advised to maintain the device between 15-40°C4.  
• 
Xpert® CT/NG: Refer to the manufacturer's instructions for specific storage requirements. Generally, Xpert® 
CT/NG cartridges should be stored in a cool, dry place away from direct sunlight. Sterility must be maintained 
during cartridge loading. 
IVD device return or disposal procedure 
NG LFA and NG LFA reader 
• 
Upon study completion, all unused NG LFA test kits and readers will be returned to DCN via FIND. 
• 
Used NG LFA test kits will be disposed of at the study site according to the site's standard operating procedures. 
• 
In case of any NG LFA device deficiencies (malfunction, usability issues, labelling discrepancies), the affected 
device(s) will be returned to DCN via FIND for analysis. The study site will document the deficiency, including 
photographs if applicable, and follow FIND's instructions for device return and shipping. 
Xpert® CT/NG  
• 
As the Xpert® CT/NG is a commercially available IVD routinely used at the study site, unused cartridges or 
supplies will be managed according to the site's standard operating procedures. 
• 
In the unlikely event of device deficiencies with the Xpert® CT/NG, the study site should follow the 
manufacturer's instructions for reporting and returning the affected device. FIND will be notified of any such 
occurrences.  
NG LFA reader shipment  
At the end of the study, any unused NG LFA test kits will be returned to FIND according to their instructions. Expired NG 
LFA test kits will be disposed of according to the study site's standard operating procedures. Any malfunctioning NG LFA 
test kits will be reported to FIND and returned according to their instructions. 
To ensure the prototype fluorescent reader is shipped safely and arrives at its destination in good working 
condition, the following shipping instructions should be followed -  
• 
Choose a box slightly larger than the reader, with enough space for ample cushioning.  
• 
Use ample cushioning materials such as anti-static bubble wrap.  
• 
Ensure the reader is surrounded and cannot move within the box. 
• 
Clearly label the box with "Fragile" stickers on all sides, including arrows indicating the upright position. 
• 
Close the box securely with packing tape, reinforcing all seams. 
• 
If the box is not sturdy, consider placing it inside a slightly larger box with additional cushioning between the 
two boxes. 
• 
 Use a reputable carrier with experience in handling fragile items.  
• 
Use a shipping service with tracking to monitor the package's progress. 
• 
Clearly label the box with your and the recipient's contact information. Notify FIND when the shipment has been 
made so that the delivery time can be anticipated.  

 
 
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IVD device accountability procedure 
To ensure the proper tracking and control of investigational devices throughout the study, the following procedures will 
be implemented: 
 
All NG LFA test kits will be stored in a locked, limited-access area at the study site and will be accessible only to 
authorised study personnel. A detailed inventory log will be maintained at each site to record the receipt, usage, and 
disposal of NG LFA test kits. The NG LFA test kits are to be used exclusively for this clinical performance study and in 
accordance with the approved CPSP. Only trained and authorised study personnel will be allowed to handle and use the  
FPD will maintain a Device Accountability Log at their site to document the physical location of all NG LFA test kits from 
shipment to the study sites until their return or disposal. 
PI or authorised designee at the study site will also maintain a Device Accountability Log. This log will document: 
• 
Date of receipt of NG LFA test kits 
• 
Unique identification of each test kit (e.g., batch/lot number, serial number) 
• 
Expiry date of each test kit 
• 
Physical storage location of the test kits 
• 
Date(s) of use for each test kit 
• 
Date of return or disposal of used test kits 
• 
Date of return of unused, expired, or malfunctioning test kits 
• 
Return/Disposal of Unused, Expired, or Malfunctioning Devices: 
The accountability of the Xpert® CT/NG will be documented in the PI's Device Accountability Log. The documentation will 
include the date of use and the unique identification of each Xpert® CT/NG cartridge used in the study. 
7.6 
Specimen collection  
Specimen collection procedure overview 
This clinical performance study will involve the collection of fresh vaginal specimens specifically for the study purposes. 
Before sample collection, participants will be provided with clear instructions on how to provide a vaginal sample.  
1. For self-collected samples, participants will be given a sterile NG LFA kit-specific swab and instructions on 
collecting the sample. Participants will be provided with a private space to collect their own vaginal sample 
using the provided swab and instructions. Always take the first sample as a self-collected sample, followed by 
provider collected.  
2. A research nurse or research healthcare provider will collect three provider-collected high vaginal samples using 
separate sterile swabs- 1. one NG LFA kit specific swab, 2. one Xpert® CT/NG Vaginal/Endocervical Specimen 
Collection kit (Cepheid) and 3. one flocked swab. This will be done using standard clinical procedures to ensure 
consistency in the sample collection technique.  
3. The order of collection of the first and second healthcare provider swabs will be randomly assigned utilising the 
randomisation functionality in RedCAP; the third swab is always used for storage/discordant analysis. Both self-
collected and provider-collected swabs will be labelled immediately with a unique identifier to ensure 
traceability and avoid mix-ups.  
4. The research team will test using the NG LFA and the Xpert® CT/NG reference standard at the bedside.  

 
 
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5. If there is no discordance testing required, one vaginal swab will be stored at -80°C for biobanking for future STI 
test development. Specimens with discordant results will be stored at -80°C before being shipped to the 
University of Pretoria for further microbiological analysis of discordant results and to test for other STI. 
NG LFA kit-specific swab (self-collected) 
Note: Always take the first sample as a self-collected sample, followed by provider collected.  
a. Wash your hands before starting. 
b.  It is important to maintain a comfortable balance during the collection procedure.  
c. 
Open the package containing the NG LFA-specific swab and remove the swab.   
d. Remove the swab, taking care not to touch the tip or lay it down. If the soft tip is touched, the swab is laid 
down, or the swab is dropped, request a new swab. 
e. Carefully insert the swab into the vagina about 5 cm (two inches) inside the opening of the vagina and gently 
rotate the swab for 10 to 30 seconds. Ensure the swab touches the walls of the vagina so that the swab absorbs 
moisture.  
f. 
Withdraw the swab without touching any surfaces. 
g. 
Hand the swab to the healthcare provider for NG LFA testing. 
h. Follow the Testing Procedure outlined below.  
Xpert® CT/NG Vaginal Specimen Collection (provider collected)  
a. Wash your hands before starting. 
b. Open the outer peel pack (which contains the two-package kit) and identify the larger cleaning swab and discard 
it.  
c. 
Open the package containing the pink-capped Xpert Swab Transport Reagent tube and individually wrapped 
collection swab. Set the tube aside before beginning to collect the sample.  
d. Open the collection swab wrapper by peeling open the top of the wrapper.  
e. Remove the swab, taking care not to touch the tip or lay it down. If the soft tip is touched, the swab is laid 
down, or the swab is dropped, request a new collection kit.  
f. 
Hold the swab in your hand, placing your thumb and forefinger in the middle of the swab shaft across the 
scoreline. Carefully insert the swab into the vagina about 5 cm (two inches) inside the opening of the vagina and 
gently rotate the swab for 10 to 30 seconds. Ensure the swab touches the walls of the vagina so that the swab 
absorbs moisture.  
g. 
Carefully withdraw the swab and continue to hold it in your hand. While holding the swab in the same hand, 
unscrew the pink cap from the Xpert Swab Transport Reagent tube.  
h. Do not spill the contents of the tube. If the contents of the tube are spilt, take a new collection kit. 
i. 
Immediately place the specimen collection swab into the transport reagent tube.  
j. 
Identify the scoreline on the collection swab shaft. Carefully break the swab shaft against the side of the tube at 
the scoreline and discard the top portion of the swab shaft. If needed, gently rotate the swab shaft to complete 
the breakage. Use care to avoid splashing contents on the skin. Wash with soap and water if exposed.  
k. 
Re-cap the swab transport reagent tube and tighten the cap securely. 
l. 
Label the transport tube with the sample identification information, including the collection date, as required. 
m. Follow the Testing Procedure outlined below. 

 
 
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NG LFA kit-specific swab (provider collected) 
a. Wash your hands before starting.  
b. Open the package containing the NG LFA-specific swab.   
c. 
Remove the swab, taking care not touching the tip or laying it down. If the soft tip is touched, the swab is laid 
down, or the swab is dropped, take a new swab. 
d. Carefully insert the swab into the vagina about 5 cm (two inches) inside the opening of the vagina and gently 
rotate the swab for 10 to 30 seconds. Ensure the swab touches the walls of the vagina so that the swab absorbs 
moisture.  
e. Withdraw the swab without touching any surfaces. 
f. 
Immediately insert the swab into the NG LFA buffer.  
g. 
Follow the Testing Procedure outlined below.  
Flocked swab (Storage/discordance) (provider collected) 
1. Wash your hands before starting. 
2. Open the package containing the NG LFA-specific swab and remove the swab.   
3. Remove the swab, taking care not to touch the tip or lay it down. If the soft tip is touched, the swab is laid 
down, or the swab is dropped, take a new swab. 
4. Carefully insert the swab into the vagina about 5 cm (two inches) inside the opening of the vagina and gently 
rotate the swab for 10 to 30 seconds. Ensure the swab touches the walls of the vagina so that the swab absorbs 
moisture.  
5. Withdraw the swab without touching any surfaces. 
6. Place the swab back into the tube for storage at 4°C.  
7.7 
Specimen-ID assignment procedure 
To ensure accurate identification and traceability of specimens throughout the study, a standardised allocated enrolment 
number will be used as the Specimen-ID.  
Specimen storage procedure 
Two provider-collected and one self-collected swab will be tested immediately at the site using the NG LFAs and Xpert® 
CT/NG. One provider-collected flocked swab will be stored in a labelled tube stored at 4°C at the clinical site. It will then 
be transported to a central facility for longer storage at -80°C. 
1.  If there are discrepancies between the NG LFA and Xpert® CT/NG results, this swab will be shipped to the 
Department of Medical Microbiology at the University of Pretoria for further analysis. 
Specimen handling procedure 
1. Swabs will be collected using aseptic techniques by qualified healthcare providers and instructed study 
participants. 
2. A standardised specimen-ID assignment and labelling procedure will be implemented immediately after 
collection.  
3. Swabs for immediate testing will be kept at room temperature - until the tests are performed. 
4. The remaining flocked swab will be placed in a labelled tube containing and stored at 4°C in a designated 
refrigerator at the clinical site. 

 
 
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5. Before transport, specimens for biobanking and discordant samples will be carefully packaged to ensure they 
remain at the correct temperature and are protected from damage. 
Specimen transport procedure 
Samples will be transported to the central facility twice weekly under cold chain conditions. At the end of the study, 
samples for shipment to the University of Pretoria will be triple-packaged and shipped via a courier service under cold 
chain conditions. All samples that have not been transferred to the University of Pretoria will only be shipped to the FIND 
biobank in the United States upon receipt of approval from the Faculty of Health Sciences Research Ethics Committee, 
and following the execution of a Material Transfer Agreement (MTA) between FPD and FIND, which will be submitted to 
the Faculty of Health Sciences Research Office. 
Specimen disposal procedure 
All samples will be used for testing or stored for future research. As this study uses Xpert® CT/NG cartridges for reference 
standard testing, the disposal procedure for cartridges and used swab samples will adhere to the manufacturer's 
guidelines and local regulations for biohazardous waste. 
Specimen accountability procedure 
Each participant will be assigned a unique study ID. All collected specimens (vaginal swabs for both NG LFA and Xpert® 
CT/NG testing) will be labelled with this unique ID, ensuring anonymity and confidentiality. 
A detailed sample log will be maintained, recording the following information for each specimen: 
• 
Unique Study ID 
• 
Date and time of collection 
• 
Type of sample (self-collected or provider-collected) 
• 
NG LFA identification number 
• 
Test results (LFA from provider-collected samples and self-tested samples and Xpert® CT/NG from provider-
collected samples) 
All data collected, including specimen information and test results, will be entered into a secure electronic database with 
restricted access. 
7.8 
Specimen assessment 
Testing procedure 
Testing procedure of the NG LFA for self-provider-collected samples (Figure 2)  
1. Assemble all the required kit components, which include:  
a. Fluorescent NG LFA Reader 
b. Buffer with medicine dropper 
c. 
NG LFA 
d. Sample tube and dropper top 
e. Appropriately collected and labelled test sample 
f. 
Stand for the sample tube (not included in the kit) 
g. 
Timer (not included in the kit) 

 
 
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Note: Aseptic technique should be observed when all kits and materials are assembled.   
Note: A reusable medicine dropper and a disposable transfer pipet may require separate training and practice for users 
with less experience transferring precise amounts of fluid.    
Note: Care must be taken to ensure the sterility of the lysis buffer bottle, which is used for ~30 tests per bottle.  
 
2. Using the medicine dropper, add 0.8ml of extraction buffer to a clean, unused sample tube.  
3. Insert the provider-collected NG LFA kit-specific swabs into the sample tube containing the extraction buffer. 
4. Gently compress the bottom of the sample tube between the thumb and forefinger and twirl the swab 10 times 
to extract the cells. 
5. Wait 1 minute with the swab in the tube (use a timer). 
6.  Compress the bottom of the sample tube again between the thumb and forefinger and twirl the swab 10 times. 
Dispose of the swab according to local regulations for biohazardous waste.  
7. Carefully attach the dropper tip to the sample tube, avoiding touching the tip.  
8. Remove the test cassette from the foil pouch and place it on a clean, flat surface. 
9. Using the dropper (not a pipette), four drops of the extracted sample from the sample tube are added to the 
circular sample port of the cassette.  
10. Allow the cassette to run for 20 minutes (use a timer).  
11. While waiting for the sample to run on the cassette. Ensure the reader is switched on and connected to a power 
source.  
12. After 20 minutes, place the cassette into the cassette slot of the reader, facing upwards. 
13. The reader will provide a result within 30 seconds. Record the result. 
a. NEGATIVE - a light will illuminate below the negative symbol  
b. POSITIVE - a light will illuminate below the positive symbol  
c. 
INVALID - a light will illuminate below the exclamation symbol 
14. In the case of an invalid result, re-run the test by reinserting the cassette into the reader and recording the 
result.  
 
 
 
 

 
 
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Fluorescent microreader operation 
 
TURN ON the battery pack (press the tiny button near the USB plug). 
Ensure the battery is connected to the POC Reader with the USB cord.  
TURN ON the FIND POC Reader by pressing the power button and holding 
for 2 seconds. The green light will turn ON.  
TURN ON the battery pack (press the tiny button near the USB plug). 
Ensure the battery is connected to the POC Reader with the USB cord.  
TURN ON the FIND POC Reader by pressing the power button and holding 
for 2 seconds. The green light will turn ON.  
INSERT CASSETTE into the POC Reader.  All three lights will flash to show 
that a cassette has been detected. The scan should take < 5 seconds. 

 
 
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A single light will indicate 
the test result 
NEGATIVE (-)      
ERROR (!)      
POSITIVE (+)    
 
 
The testing procedure of the Xpert® CT/NG device for provider-collected samples 
1. Obtain the following items:  
a. Xpert® CT/NG cartridge  
b. Transfer pipette (provided)  
c. 
Appropriately collected and labelled provider-collected test sample  
2. Open the cartridge lid.  
3. Gently invert the transport tube 3 to 4 times to ensure adequate sample and transport matrix mixing.  
4. Unwrap the transfer pipette.  
5. Open the transport tube lid, compress the bulb of the transfer pipette, insert the pipette into the transport 
tube, and release the bulb to fill the transfer pipette above the mark on the pipette shaft (Figure 1). Ensure the 
pipette is filled with no air bubbles present. 
6. Empty the pipette’s content into the sample chamber of the cartridge. 
7. Close the cartridge lid. 
8. See Xpert® CT/NG Package-Insert for details on how to run the test.  
Procedure for assessment of the outcome 
Procedure for assessment of outcomes related to IVD device performance 
 Two provider-collected swabs and one self-collected swab will be tested immediately at the bedside using the NG LFAs 
and Xpert® CT/NG test (see Testing procedure 7.10.1.1 and 7.10.1.2).  
The results of the NG LFA will be recorded as positive, negative or invalid.  
 
Results of the LFA will not be used for any treatment decision and will only be collected for research purposes.   
This is a diagnostic accuracy study that does not use test results for clinical decision-making. All study personnel are 
made aware that the novel NG LFA under study is for research purposes only and cannot be used to determine whether 
to initiate treatment or for any other clinical management decisions. 
Procedure for assessment of outcomes related to IVD device safety 
The IVD under investigation will not be used for treatment decision making, and therefore, there are no anticipated 
adverse device effects. Any discomfort during sample collection will be documented and monitored. 

 
 
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7.8.1.1.1 
Laboratory parameters procedure 
 
In case the NG LFA and Xpert® CT/NG assay results are discordant, specimens will be shipped to the Department of 
Medical Microbiology at the University of Pretoria to identify potential cross-reactions with non-gonococcal Neisseria 
species. We will perform molecular detection of any Neisseria species, including Neisseria gonorrhoeae, Neisseria 
meningitidis, and specific other Neisseria species. 
 
The following assays will be used for the discordant samples:  
1) Neisseria genus-specific assay (melting curve analysis using hybridisation probes) 
2) LightMix NG and CT kit 
3) In-house N. meningitidis PCR assay (hydrolysis probe) 
4) Species-specific PCR for N. lactamia and N.polysaccharea ( this was done only for those that showed discordance 
between above 1 and 2) 
7.8.1.1.2 
Procedure for assessment of other outcomes 
 
Outcome 5:  
• 
Systems usability score survey will be administered to all healthcare workers who are manipulating the NG LFA 
during month 3. The survey (Annex 8) will be self-administered on paper forms which will then be entered into 
RedCap by the designated RA 
• 
A TFA acceptability survey relating to the NG LFA will be administered to all healthcare workers who are 
manipulating the NG LFA during month 3. The survey (Annex 8 XX) will be self-administered on paper forms 
which will then be entered into RedCap by the designated RA 
• 
Focus group discussions (FGD) among the healthcare workers who are conducting the study will be conducted 
during month 5 in groups of 4 to 8 HCWs. The FGD will be led by a qualitative researcher using the FGD 
discussion guide (Annex 8). The FGD will be recorded, transcribed, and coded using inductive and deductive 
coding, and the analysis will be thematic.  The FGD will be conducted in English.  Recordings will be deleted once 
the transcriptions are completed. The FGD will cover themes relating to Outcome 5 and Outcome 6 
• 
Focus group discussions (FGD) among the healthcare workers who work at the study site but are not part of the 
study: the HCW will be consented and provided an education session by the study team regarding the NG LFA. 
The FGD will be conducted during month 5 of the study and will consist of at least 2 FGD of 4 to 8 HCWs for each 
FGD.  The FGD will be led by a qualitative researcher using the FGD discussion guide (Annex 8). The FGD will be 
recorded, transcribed, and coded using inductive and deductive coding, and the analysis will be thematic.  The 
FGD will be conducted in English.  Recordings will be deleted once the transcriptions are completed 
 
Outcome 6:  
• 
TFA acceptability survey relating to self-sampling among participants undergoing testing procedures: Study staff 
will administer the TFA survey to each participant after the participant has undergone all sampling procedures 
(Annex 8). The survey administration should take between 10 and 15 minutes to complete. The paper versions 
of the CRF will be entered into Open Clinica by designated research staff.  
• 
The TFA acceptability survey relating to perceptions on self-sampling by the HCW will be completed by all HCW 
conducting the study during month 3. The survey will be self-administered on paper forms and entered into 
RedCap by the designated research staff.  

 
 
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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.   
Procedure for each visit 
Visit: Enrolment, Sample Collection and Testing 
1. Participant Registration and Identification: 
a. Obtain written informed consent from the participant after ensuring they have read and understood the 
study information sheet. 
b. Assign a unique participant identification number to maintain confidentiality throughout the study. This 
number will be used as an identifier for all study information, including questionnaires, interview guides, 
specimen labelling, and laboratory tests. 
2. Questionnaire Completion: 
1. Assist the study participant in completing the short questionnaire. 
2. Ensure all socio-demographic, sexual, and clinical history questions are answered accurately  
3. Address any questions or concerns the participant may have regarding the questionnaire. 
3. Routine Genital Examination and Recording: 
a. A qualified healthcare worker will conduct a routine genital examination, following standard clinical 
practices. Diagnosis of VDS will be based on self-reported presence of symptoms consistent with VDS or 
increased or abnormal vaginal discharge, sometimes with odour or irritation. 
b. Document the findings of the examination in the RedCAP platform, ensuring thoroughness and accuracy. 
 
4. STI Counselling and Safe Sex Education: 
a. Provide comprehensive counselling to the participant STIs. 
b. Discuss the occurrence and implications of asymptomatic infections, emphasising the importance of regular 
testing. 
c. 
Educate the participant on the proper use of condoms and other safe sex practices to reduce the risk of 
STIs. 
 
5. Sample Collection: 
Self-Collected Sample (x 1): 
a. Provide the participant with a kit-specific vaginal swab for NG LFA testing. 
b. Offer clear instructions on self-collecting the sample, ensuring they understand the procedure and feel 
comfortable performing it. 
c. 
If the participant is not willing to provide a self-collected sample, then provider-collected vaginal samples 
will be collected and used for performance testing and analysis only.   
d. Record any Adverse Events. 
Provider-Collected Samples (x 3): 
a. Explain the sample collection procedure to the participant, ensuring their comfort and understanding. 
b. Collect three high vaginal swabs using appropriate techniques: 

 
 
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o 
One kit-specific swab for NG LFA testing. 
o 
One swab in Xpert® CT/NG Vaginal/Endocervical Specimen Collection kit (Cepheid). 
o 
One flocked swab for further microbiological analysis if needed. 
c. 
Record any Adverse Events. 
6. NG LFA and Xpert® CT/NG Testing: 
a. Perform the NG LFA test on the collected samples according to the protocol. 
b. Conduct Xpert® CT/NG testing on the appropriate sample as per the assay protocol. 
c. 
Record the test results accurately in source documents. 
7. Sample Storage: 
a. Store collected flocked swabs according to the study protocol and laboratory guidelines. 
b. Ensure proper labelling and tracking of samples (flocked swabs) to maintain integrity and avoid confusion. 
8. Treatment (if applicable): 
All participants are provided with antimicrobial treatment at presentation if symptomatic. If the participant is 
willing to wait 90 minutes, results of the Xpert® CT/NG assay will be used for pathogen-directed therapy of 
Neisseria gonorrhoeae (500mg ceftriaxone intramuscular injection) and/or Chlamydia trachomatis (azithromycin 
1g oral dose) in case of positive test result(s); these will be available within 90 minutes of sampling. 
 
 Symptomatic individuals with negative Xpert® CT/NG tests and those without a result available at the time of 
treatment will be provided with the standard syndromic management antibiotic regimen (azithromycin 1g start 
oral dose, ceftriaxone 250mg intramuscular injection, and metronidazole 2g stat dose) as per South African 
guidelines.  
 
The contact details of asymptomatic individuals will be recorded, and if they are not willing to wait for the 
result, they will be contacted telephonically to discuss their Xpert® CT/NG result; individuals with a positive STI 
test will be provided with the same pathogen-directed treatment as symptomatic individuals.  
 
Results of the LFA will not be used for any treatment decision and are only collected for research 
purposes. Only the results from Xpert® CT will be communicated to the individual.  
 
9. Partner Notification and Leaflet: 
a. Provide the participant with a partner notification leaflet explaining the importance of informing their 
sexual partners about the potential exposure to STIs. 
b. Encourage participants to discuss testing and treatment options with their partners to prevent further 
transmission. 
10. Study Visit Completion: 
a. Provide a voucher of R100 for the local grocery store (e.g. Shoprite, Spar, Checkers) for their participation in 
the study. 
b. Remind the participants of the study team's contact information in case they have any questions or 
concerns. 

 
 
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Once the participant receives Xpert® CT/NG result and treatment, all study-related procedures will be considered 
complete.  
 
Study Periods 
Consent (ICF)/Screening/Study visit 
Notes 
Visit 
1 
  
Participant information  
X 
  
Participant consent Form (ICF)  
X 
  
Demographics  
X 
  
Medical history  
X 
 
Routine genital examination 
X 
Self-collected sample (1) 
X 
High vaginal swab 
Provider-collected sample (3) 
X 
High vaginal swabs  
NG LFA testing 
X 
Xpert® CT/NG testing 
X 
Storage of swab 
X 
Treatment  
X 
Adverse Events  
X 
Routine STI counselling 
X 
Telephone number  
X 
Partner notification leaflet   
X 
 
Participant voucher  
X 
 
Suspension or termination of the clinical performance study 
Procedure for suspension or termination 
The Sponsor, as per the recommendations of the TSC and DSMC, may terminate the performance study prematurely or 
at a particular study site or suspend the PI, according to the following circumstances 
• 
ethical concerns 
• 
insufficient participant recruitment. 
• 
when the safety of the participants is doubtful or at risk. 
• 
when monitoring identifies serious or repeated deviations on the part of a PI. 
When suspension or premature termination occurs, the Sponsor justifies its decision in writing and promptly informs the 
other parties with whom it is in direct communication. When, for any reason, the Sponsor suspends or prematurely 
terminates the performance study at an individual study site, the Sponsor ensures that the CEC is notified. The PI and 
Sponsor keep each other informed of any communication from the CEC. 

 
 
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Procedure for resuming the clinical performance study after temporary suspension. 
After analysing the reason(s) for the suspension and implementing the necessary corrective actions, the sponsor decides 
to lift the suspension. It informs the PI of the rationale and provides them with the relevant data supporting its decision. 
 The Sponsor submits new safety information and any modified documents to the CEC. Upon receiving CEC approval, the 
performance study can resume. 
Procedure for follow-up with participants after termination of the clinical performance study 
NA.  
7.9 
Study duration and flowchart.  
 
2024 
Jul 
Aug 
Sep 
Oct 
Nov 
Dec 
Study Protocol  
 
 
 
 
 
 
CEC approval 
 
 
 
 
 
 
Staff training 
 
 
 
 
 
 
Recruitment  
 
 
 
 
 
 
Data analysis  
 
 
 
 
 
 
Report 
 
 
 
 
 
 
 
 

 
 
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2025 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
Sept 
Oct  
Nov  
Dec  
Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
CEC approval 
 
 
 
 
 
 
 
 
 
 
 
 
Staff training 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment  
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis  
 
 
 
 
 
 
 
 
 
 
 
 
Report 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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8 
SAFETY 
The Principal Investigator and any qualified designees are responsible for the detection, medical management, 
documentation, recording and reporting of all events and the follow-up and reporting of all Adverse Events and Adverse 
Device Effects. 
8.1 
Terms and definitions 
Adverse Event (AE) (Art. 2(60) IVDR) 
Any untoward medical occurrence, unintended injury, or untoward clinical signs in study participants, users, or 
other persons in the context of a performance study, whether or not related to the device for the performance 
study. 
Adverse Device Effect (ADE) (ISO 20916) 
Adverse event related to the use of an IVD medical device under investigation. 
Device Deficiency (DD) (Art. 2 Abs 62 MDR) 
Inadequacy of a medical device is related to its inadequacy in the identity, quality, durability, reliability, safety, 
or performance for performance study, including malfunction, use errors, or inadequacy in information supplied 
by the manufacturer. 
Device Deficiency with Serious Adverse Device Effect (SADE) potential (Art. 76 IVDR; ISO 20916) 
Any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, 
intervention had not occurred, or circumstances had been less fortunate. 
Malfunction (ISO 20916) 
Failure of an IVD medical device under investigation to perform in accordance with its intended use when used 
in accordance with the instructions for use or CPSP. 
Serious Adverse Event (SAE) (Art. 2(61) IVDR) 
Any adverse event that led to any of the following: 
(a) 
a patient management decision resulting in death or an imminent life-threatening situation for the 
individual being tested or in the death of the individual's offspring, 
(b) 
death, 
(c) 
serious deterioration in the health of the individual being tested or the recipient of tested donations or 
materials, which resulted in any of the following: 
(i) 
life-threatening illness or injury, 
(ii) 
permanent impairment of a body structure or a body function, 
(iii) 
hospitalisation or prolongation of patient hospitalisation, 
(iv) 
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
(v) 
chronic disease, 
(d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect. 
Note: planned hospitalisation for a pre-existing condition or a procedure required by the CPSP without a serious 
deterioration of the participant's health status is not considered an SAE. 
Serious Adverse Device Effect (SADE) (ISO 20916) 
Adverse device effect (ADE) that has resulted in any of the consequences characteristic of a serious adverse 
event. 

 
 
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8.2 
Expected Adverse Events and Mitigation Plans 
Given that the NG LFA will not be used for treatment decisions and patients will be treated according to the standard of 
care in South Africa, the likelihood and severity of some adverse events may be reduced. Self-collection of high vaginal 
swabs is considered safe and accepted in pregnancy.  
8.3 
Solicited Adverse Events 
After vaginal swab sample collection (self or physician-collected), participants will be asked if they have experienced any 
issues during and after the collection. 
8.4 
Categorization and Assessment of Adverse Events 
All adverse events will be reported in a final clinical performance study report.  
Casual relationships of SAE 
A causal relationship towards the IVD medical device or the procedure of the investigation should be rated by the PI and 
the Sponsor as follows: 
• Not related: The relationship to the device or procedures can be excluded. 
• Possible: The relationship with using the investigational device is weak but cannot be ruled out completely. 
Alternative causes are also possible. 
• Probable: The relationship with using the investigational device seems relevant and the event cannot reasonably 
be explained by another cause. 
• Causal relationship: The serious event is associated with the investigational device or with procedures beyond 
reasonable doubt. 
Causality will be assessed using the WHO-UMC (WHO-Uppsala Medical Center) assessment system. 
Adverse events categorization 
The adverse events will be categorised by the PI and the Sponsor using the following algorithm: 
• Does the AE meet the seriousness criteria? 
o 
No, it is not serious: AE 
o 
Yes, it is serious: SAE 
• If AE, is it device related? 
o 
No, not-related: AE 
o 
Yes, related AEs: ADE 
• If SAE, is it device related? 
o 
No, not-related: SAE 
o 
Yes, it is a possibility, probably, or causally related SAE: SADE 
• If SADE, is it anticipated (within the expected type, severity and frequency of the complications)? 
o 
No, unanticipated SADE: USADE 
o 
Yes, anticipated SADE: ASADE 
Adverse events severity grading 
• Mild (Grade 1): asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not 
indicated. 

 
 
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• Moderate (Grade 2): minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental 
(ADL). 
• Severe or medically significant but not immediately life-threatening (Grade 3): hospitalisation or prolongation of 
hospitalisation indicated; disabling; limiting self-care (ADL). 
• Life-threatening consequences (Grade 4): urgent intervention indicated. 
• Death (Grade 5) 
8.5 
Documentation and reporting 
Device deficiencies (DD) and all adverse events (AE), including all serious adverse events (SAE), are collected, fully 
investigated and documented in the source document and appropriate CRF. Information about AEs will be collected during 
the study population period, i.e. from participant’s informed consent until the last CPSP-specific procedure (at maximum 
1 day 120 minutes). 
Documentation and reporting responsibilities of the PI 
• 
At the study visit, the participant will be directly asked about any experiences of discomfort, pain, bleeding, or 
other unusual symptoms following the vaginal swab procedure. Participants will be provided with contact 
information for the study team and encouraged to report any concerning symptoms 
• 
The PI or designee records clinically relevant AEs together with an assessment as to whether the IVD device or 
sampling procedure was a cause of the event on a CRF. 
• 
The documentation of AEs (including SAEs) by the PI includes information about the participant, diagnosis or 
symptoms, start and stop dates of event, event treatment, event resolution, the PI’s assessment of seriousness, 
causal relationship to IVD device and/or study procedures, and expectedness. 
• 
PI shall report to the Sponsor and TSC within 24 hours after becoming aware of the following events:  
o 
All SAEs and SADEs 
o 
Health hazards that require measures  
o 
All DDs that could have led to a SADE 
 
SAEs and SADEs are reported to the Sponsor on an SAE report form (Annexes, chapter 17) within 24 hours of site awareness 
of the SAE/SADE.  
Documentation and reporting responsibilities of Sponsor 
• 
The Sponsor reviews the investigator's assessment of all AEs, determines and documents in writing their 
seriousness and relationship to the IVD medical device under investigation; in case of disagreement between the 
Sponsor and the PI, the Sponsor shall communicate both opinions to the Ethics Committee the TSC and CA if 
applicable. 
• 
The Sponsor reviews all DD, determines and documents in writing whether they could have led to a SADE; in case 
of disagreement between the Sponsor and the Principal Investigator(s), the Sponsor shall communicate both 
opinions to the Ethics Committee, the TSC and CA if applicable. 
• 
The Sponsor ensures that all SAEs and DDs that could have led to an SADE are promptly reported to the CEC and 
the TSC when required by the CEC. 
• 
If applicable, the Sponsor will ensure to report to CA, without delay, all SAE that has a causal relationship with the 
device, the comparator or the study procedure or where such causal relationship is reasonably possible, as well 
as DD that could have led to a SADE if appropriate action had not been taken, intervention had not occurred, or 

 
 
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circumstances had been less fortunate. Furthermore, any new findings about those events will be reported to CA 
without delay. When necessary to ensure timely reporting, the Sponsor may submit an incomplete report 
followed up by a complete report. 
• 
The Sponsor will, in the case of a multicentre clinical performance study, inform all PIs and TSC in writing of all 
SAE at all study sites that have been reported to the sponsor and ensure that they are reported to their CEC when 
required by national regulations or by the ethics committee, whichever is more stringent; this information shall 
be sent to all the PIs within a time frame established based on the perceived risk as defined in the risk analysis 
report. 
• 
The Sponsor will, in the case of SADE and DD that could have led to SADE, determine whether the risk analysis 
needs to be updated and assess whether corrective or preventative action is required. 
• 
The Sponsor will provide the CA, the CEC and TSC with the documentation at their request.  
Medical management of SAEs and SADEs 
The study team will ensure that study participants with SAEs receive standard medical care in the country. If treatment 
costs are extra, the study will cover those costs. 
Time period to collecting SAEs information 
For each participant, information on SAEs will be collected from the signing of the ICF until the end of the study. 
Investigators are not obligated to seek SAEs after the conclusion of the trial participation actively. However, if the 
investigator learns of any SAE, including death, at any time after a participant has been discharged from the trial, and 
he/she considers the event to be reasonably related to the IVD or trial participation, the investigator must promptly notify 
the Sponsor. 
Follow up of SAEs and SADEs 
All SAEs will be followed until resolution, stabilisation, the event is otherwise explained, or the participant is lost to follow-
up. Prompt notification by the PI to TSC of an SAE/SADE is essential so that legal obligations and ethical responsibilities 
towards the safety of participants and the safety of a Trial intervention under clinical investigation are met.  
Where applicable, FPD has a legal responsibility to notify the local regulatory authority and other regulatory agencies about 
the safety of a trial intervention under clinical investigation.  
 
Pregnancies: Pregnancy reporting is not applicable in this study. 
Expedited and annual reporting to the Competent Ethics Committee and Competent Authority 
The Sponsor reports the following events to the CEC and CA within 72 hours of awareness.  
a) Any SAE that has a possible, probable or causal relationship with the investigational device, the comparator device 
or a test procedure; 
b) Any DD that could have resulted in SAE under less propitious circumstances or if appropriate action or intervention 
had not taken place; 
c) Any new findings relating to a reported incident. 
In order to ensure the reporting is not delayed, an incomplete report may be provisionally provided. 
If safety and health hazards require measures to be taken immediately during the conduct of the investigation, the Sponsor 
notifies the CEC and CA within 48 hours of these measures and the circumstances which made them necessary. 

 
 
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Periodic safety reporting 
The sponsor submits an annual safety report (ASR) to the CEC and the CA. The ASR contains a list of all SADEs and DDs, a 
report on their degree of seriousness, causal relationship with the MD and procedure, and a report on participants’ safety 
with information required by the CEC and CA. 
 
8.6 
Data management system 
The study will use RedCap Version 14.7. This system is a password-protected online platform that ensures secure and 
efficient study data management. RedCap is hosted on a secure cloud service, with regular testing conducted before the 
study begins to verify its functionality and reliability. Data entry will be performed by trained project data entry clerks 
authorised by the Principal Investigator (PI)Data collection and entry. 
 
Data will be recorded initially on pCRFs by the study team. These pCRFs will then be entered into RedCap by dedicated 
data entry clerks. To ensure accuracy and quality: Automated range checks within RedCap will help identify data entry 
errors by flagging values that fall outside of predefined ranges 
Data review and database cleaning 
Data will be cross-checked against source documents to confirm accuracy. Any discrepancies identified will be addressed 
and corrected as needed. Regular validation checks will ensure that RedCap adheres to required data processing and 
storage standards, thus maintaining system performance and data integrity. 
Data verification 
RedCap has advanced security features to ensure password protection, access control and audit trail: Each user will have 
individual accounts with unique passwords. Detailed records will be maintained, documenting user access, including 
dates and levels of privilege, to ensure secure data handling. An audit trail system will log all data entries, modifications, 
and queries, providing a comprehensive history of all data management activities. 
 
Data analysing and archiving 
Each enrolled participant will be assigned a unique study participant ID number to identify samples and information. The 
use of an anonymous participant ID will ensure the participant’s confidentiality. To ensure that each clinical sample can 
be linked to clinical and laboratory results and tracked effectively from the collection site to the end-user, all lab request 
forms and sample collection will be labelled using the participant’s ID. Post-analysis, data will be archived following the 
retention period specified in the data management plan. All records will be stored securely to guarantee their 
retrievability and protection against unauthorised access. 
 
Electronic database validation 
The validation procedures for RedCap will adhere to a strict data management protocol. Detailed documentation will 
define the data receipt, transfer, and processing criteria, ensuring that all data sent to the Sponsor is de-identified, with 
no personal identifiers included. Routine consistency checks will confirm that the system meets the established 
requirements and functions as expected. Measures will be implemented to ensure that all data entered into the system 
is traceable, complete, reliable, consistent, and logically structured. Reports generated by RedCap will undergo thorough 

 
 
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review to verify accuracy and alignment with the source data. Comprehensive audit trails will be maintained for all data 
entries and modifications, ensuring a permanent record of changes and preventing data deletion. The system will be 
secured through robust measures to prevent unauthorised access, safeguarding the confidentiality and integrity of the 
data. A current and up-to-date record of all personnel with access to the database, including their access levels, dates, 
and privileges, will be maintained. All finalised documents will be signed by the PI or an authorised designee, ensuring 
accountability and compliance with regulatory standards. 
 
Data quality assurance 
9 
STATISTICAL METHODS 
A dedicated statistical analysis plan (SAP) will be developed before the study's initiation. The document will describe in 
detail the procedures to evaluate each of the study outcomes. Therefore, this section only provides a high-level summary 
of the analysis strategy.  
9.1 
Determination of sample size 
The sample size has been determined using a previously published formula [Equations 6.1 and 6.3] (ref). In the ANC 
population, to detect a sensitivity of 80% [65% - 95%] and a specificity of 98.1% [93.1% - 100%] with 80% power, 56 
confirmed positives and 59 confirmed negatives are needed, respectively. To detect a difference <5% between the 
sensitivity/specificity of clinician-collected and self-collected samples in this population, with the assumption that the 
observed difference will be 1% for both sensitivity/specificity, with alpha 5% and power 80%, 39 positive and 39 negative 
paired samples are needed (ref). To obtain 56 confirmed positives with a prevalence estimate of 8% and a power of 80%, 
778 participants needed to be screened.  
 
In the symptomatic population, to detect a difference <5%, with the assumption that the observed difference will be 
1.5% for both sensitivity/specificity, with alpha 5% and power 80%, 76 confirmed positive and  76 confirmed negative 
paired samples are needed (ref). To obtain 76 confirmed positives with a prevalence estimate of 18% and a power of 
80%, 461 participants need to be screened. 
 
Sample size for operational research aspects 
• 
SUS and TFA among HCW conducting the NG LFA: given that there is a limited number of HCW who will be 
manipulating the NG LFA all HCW will be included in the survey. The analysis will be descriptive 
• 
Qualitative aspects: the sample size will be defined based on the saturation point, meaning that all substantive 
themes have been identified and no new, substantiative themes emerge from additional interviews. It must be 
noted that due to the limited number of HCW who have experience with the NG LFA there is a risk that 
saturation may not be reached.  
9.2 
Statistical Analysis Plan 
This section summarises the planned statistical analyses of the primary and secondary endpoints.  
Populations for analyses 
For analysis, the following populations are defined: 
 

 
 
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Populations for analyses 
 
If the participant is not willing to provide a self-collected sample, then provider-collected vaginal samples will be 
collected and included in the analyses of Primary Objective 1 and Secondary Objective 1.  
General Methodology 
Table below summarises the usual methodology to report results of diagnostic tests when compared with a reference 
standard. 
 
Definition of test results and classifications  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Point estimates of sensitivity and specificity, with 95% confidence intervals based on Wilson’s score method, will be 
calculated and reported in tables and graphically (forest plot).  
Population 
Description 
Enrolled/Intention-To-Test 
(ITT) 
All participants who sign the Informed Consent Form (ICF) 
Modified-Intention-To-Test 
(MITT) 
All participants in ITT for whom at least one test result is available i.e., participants 
with incomplete results (e.g., reference test results is available, but index test not 
done) 
Per Protocol Population (PP) 
All participants in ITT for whom results for all tests are available (complied with the 
protocol) 
Per Protocol Modified 
Population (PPM) 
All participants in ITT for whom results for all tests on provider-collected vaginal 
samples are available 
                                        Reference standard classification 
Index Test 
Result 
 
Positive  
Negative 
Total 
Predicted positive 
a 
b 
(a + b) 
Predicted negative  
c 
d 
(c + d) 
Total 
(a + c) 
(b + d) 
(a + b + c + d) 
a = True Positives 
b = False Positives 
c = False Negatives 
d = True Negatives 
Sensitivity = a / (a + c) 
Specificity = d / (b + d) 
Positive Predictive Value = a / (a + b) 
Negative Predictive Value = d / (c + d) 

 
 
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Primary outcome analysis 
 
Secondary outcomes analyses 
Outcome 
Analysis Population 
Statistical Analysis Methods 
Point estimates of sensitivity, 
specificity, positive and negative 
predictive value (PPV and NPV 
respectively) with 95% 
confidence intervals 
Symptomatic non-pregnant 
women in the per protocol 
modified population. 
As defined in the general methodology section 
Point estimates of the 
percentage difference in 
Sensitivity/Specificity between 
self-collected and provider-
collected vaginal samples with 
95% confidence intervals 
Pregnant women attending 
ANCs in the per protocol 
population. 
The percentage differences in diagnostic 
performance will be calculated as: 
 
DIFFsensSELF-PROVIDER = SENSSELF – SENSPROVIDER 
 
DIFFspecSELF-PROVIDER = SPECSELF – SPECPROVIDER 
 
95% confidence intervals will be calculated based 
on Tango’s score method.  
 
McNemar Test will be performed to assess the 
null hypothesis that the proportions of discordant 
pairs between the two index tests (self-collected 
vs provider-collected) are equal.  
Point estimates of the 
percentage difference in 
Sensitivity/Specificity between 
self-collected and provider-
collected vaginal samples with 
95% confidence intervals 
Symptomatic non-pregnant 
women in the per protocol 
population. 
As outlined for secondary endpoint 2 
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. 
All participants who 
provided at least one 
sample type. 
Descriptive statistics represented by absolute 
numbers and proportions per population (ANC vs 
symptomatic).  
 
The statistical significance of the differences may 
be assessed using Chi2 or Fisher’s Exact Test.  
Outcome 
Analysis Population 
Statistical Analysis Methods 
Point estimates of sensitivity, 
specificity, positive and negative 
predictive value (PPV and NPV 
respectively) with 95% 
confidence intervals 
Pregnant women attending 
ANCs in the per protocol 
modified population 
As defined in the general methodology section 

 
 
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Mixed methods: Distribution of 
acceptability questionnaire score 
and system usability score, 
thematic analysis of SSIs and 
FGDs. 
SUS and TFA: all HCWs who 
are involved in preforming 
the NG LFA testing 
Qualitative: the above plus 
HCW working at the clinic 
the study is taking place in 
but not involved in the study 
Descriptive statistics represented by absolute 
numbers, proportions, or means (where 
applicable). 
 
Thematic analysis to analyse free-response 
questions to identify key themes and messages. 
Mixed methods: Distribution of 
acceptability questionnaire score, 
the proportion of participants in 
each population who prefer self-
collected to provider-collected 
samples, thematic analysis of 
FGDs.  
LFA survey: All participants 
who undergo the sampling 
procedure 
LFA survey HCW: HCW 
involved in the study 
Qualitative: the above  + 
HCW working at the clinic 
the study is taking place in  
Descriptive statistics represented by absolute 
numbers, proportions, or means (where 
applicable) within each population (ANC, 
symptomatic, and HCWs). 
 
Thematic analysis to analyse free-response 
questions to identify key themes and messages. 
 
Subgroup analyses 
Subgroups to be defined in the detailed SAP. 
Descriptive Statistics 
Descriptive statistics tables will be generated to summarise the characteristics of the participants in the ITT, MITT, PP and 
PPM populations. The number of participants included and excluded will be reported. Among the included participants, 
this information will be broken down by the previously defined subgroups.  
 
Categorical variables will be presented in absolute numbers and percentages. Continuous variables will be summarised 
with means, standard deviations, and interquartile ranges.   
Safety Analyses 
See secondary endpoint 4. 
Additional Analyses 
Additional exploratory analyses will be described in the SAP.  
Missing data 
Missing data will not be imputed and therefore excluded from the analysis. This will be reported in the descriptive 
statistics tables.  
Statistical software 
The analysis will be performed using the R statistical language (version 3.4 or higher) and Microsoft Excel (version 16.16 or 
higher). 

 
 
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10 QUALITY ASSURANCE AND REGULATORY ASPECTS 
10.1 Quality assurance and control 
The PI ensures that experience and scientific or clinical knowledge are guaranteed and documented for all members of the 
study team at the study site in order to adequately conduct the performance study, including specific training as applicable 
to each role. All members of the study team receive specific training on the performance study, and such training is 
documented in the Study Site File. 
Study documentation 
The following documentation must be maintained throughout the study period. 
Source data and source documents 
The investigator/institution should maintain adequate and accurate source documents and study records that include all 
pertinent observations on each of the site’s study participants (source data). Source data should be attributable, legible, 
contemporaneous, original, accurate, and complete. Changes to source data should be traceable by adding initials and a 
date, should not obscure the original entry, and should be explained if necessary. 
Source documents provide evidence for the participants' existence and substantiate the integrity of the data collected. 
They are filed at the investigator’s site. The investigator must maintain accurate documentation that supports the 
information entered in the CRF. 
 
The definition of what constitutes source data can be found in the table below.  
Participant data will include Demographics, clinical examination, and laboratory testing.  Observations from the clinical 
examination will be recorded directly in the paper CRF. 
Electronic CRF (direct data capture) will be used to ease data entry by non-clinical and non-laboratory staff whenever 
possible. If this is not feasible, a paper CRF will be used to mirror the design of the electronic CRF. The paper CRF will consist 
of some data that has been entered directly (e.g., source data) and some that has been transcribed from other sources, 
such as the lab report. Refer to the table below. Any source data directly entered into the paper CRF must be signed and 
dated by the person who generated the data.   
 
Type of Data 
Original Place of Entry 
Study Details  
CRF 
Demographics 
CRF 
 Clinical presentation 
CRF 
Physical examination  
CRF 
NG LFA and GX Testing  
CRF 
Partner notification leaflet    
CRF 
Qualitative questionnaire  
CRF 
 
The Investigator must permit study-related monitoring, audits, institutional review board/independent ethics committee 
(IRB/IEC) review, and regulatory agency inspections and provide direct access to participant medical records and source 
documents used for this study 

 
 
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Case Report Forms 
CRFs will be developed to capture the data for each enrolled participant as required by the CPSP. The CRFs shall include 
information on each participant/specimen at commencement and during the clinical performance study, including use of 
the IVD device, adverse events, and any other relevant information. 
Data is first captured on paper-CRF, then entered into RedCap electronic database by single data entry by authorised 
personnel who are listed on the study delegation log. No participant’s personally identifiable information shall be 
included within the CRF. 
Storage of biological material and related health data 
Coded specimens and associated personal data will be stored in a FIND biobank only if participants have explicit consent 
for further use. This consent is obtained independently of the participant's decision to enrol in the study. Specimens will 
be transferred onwards to partner test development organisations, with whom FIND will partner for developing LFAs and 
molecular diagnostic tests for NG and CT. FIND will remain the ultimate custodian when samples are sent to third-party 
laboratories. 
Specimens and personal data of participants who do not consent to further use will be stored at FPD's storage facility for 
5 years after the study’s completion. After this period, specimens will be destroyed, and data will be anonymised. 
 
Archiving of essential clinical investigation documents 
All performance study documents must be archived for a minimum of 10 years after regular or premature termination of 
the study. 
10.2 Monitoring and monitoring plan 
Study monitoring will be performed according to the Monitoring Plan. 
The Sponsor will be allowed access to all source documents needed to verify the entries in the CRFs and other CPSP-related 
documents, provided that participant confidentiality is maintained in accordance with applicable laws.  
The Sponsor will be responsible for inspecting the CRFs at regular intervals throughout the study and verifying the 
adherence to the CPSP and the completeness, consistency, and accuracy of the data being entered. The monitoring 
standards require full verification for the presence of informed consent, adherence to the inclusion/exclusion criteria, 
documentation of SAEs/SADEs and the recording of the main efficacy, safety, and performance endpoints. 
Once the study starts, an initiation visit will be performed at the study site. A routine visit will be performed every year or 
as required, and a final visit will be performed after the last patient has finished the study in the site. During each 
monitoring visit, risk-based monitoring of new data will be performed. The Sponsor will perform monitoring activities 
according to Sponsor’s internal SOP on monitoring clinical performance studies.  
Each visit will be documented in a monitoring report. The sponsor may decide to make additional monitoring visits based 
on the quality of the data. 
10.3 Audits and inspections 
The PI or institution supports the Sponsor in performing auditing activities and, when relevant, ethics committee reviews 
and RA inspections. 
The PI or institution provides direct access to source data during and after the performance study for Sponsor audits, ethics 
committee reviews and RA inspections. 

 
 
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As required, the PI or institution obtain permission for direct access to source documents from the participant and/or 
hospital administration before starting the performance study.  
10.4 Regulatory aspects 
Clinical Performance Study Plan amendments 
Substantial amendments are implemented only after approval by the TSC, CEC and the CA. The use of waivers from the 
CPSP is prohibited. Under emergency circumstances, deviations from the CPSP to protect the rights, safety and well-being 
of the participants may proceed without prior approval by the Sponsor, the TSC, the CEC and the CA, but a notification is 
required. Such deviations shall be documented and reported to the Sponsor, the CEC, and the CA within 2 days. 
All non-substantial amendments are communicated to the TSC and CEC together with the Annual Safety Report (ASR). The 
ASR shall include any deviations from the CPSP that may have affected the rights, safety or well-being of the participant or 
the scientific integrity of the clinical performance study. 
Deviation from the Clinical Performance Study Plan 
The Investigator is not allowed to deviate from the CPSP. Any deviation from the CPSP must be documented, reported, 
and analysed according to the following procedures. The Investigator must promptly report any CPSP deviation to the 
Sponsor and the TSC within one week of its occurrence. The Sponsor, in collaboration with the TSC and the DSMB, if 
applicable, will analyse the impact of the deviation on the study participants, data integrity, and overall study results. For 
any CPSP deviation, the Investigator must implement appropriate corrective actions to mitigate any immediate risks to 
participants and prevent recurrence of the deviation. Corrective actions must be documented and reported to the 
Sponsor and TSC. For any CPSP deviation, the Investigator must implement appropriate corrective actions to mitigate any 
immediate risks to participants and prevent recurrence of the deviation. Corrective actions must be documented and 
reported to the Sponsor and TSC.  
11 CONFIDENTIALITY AND DATA PROTECTION 
The Sponsor and the PI affirm and upholds the principle of the participant’s right to privacy and that they shall comply with 
applicable privacy laws. Especially, anonymity of the participants shall be guaranteed when presenting the data at scientific 
meetings or publishing them in scientific journals. Individual participant medical information obtained as a result of this 
study is considered confidential and disclosure to third parties is prohibited. 
For data verification purposes (monitoring) the PI or institution provide direct access to source data during and after the 
performance study to the Sponsor’s personnel, or to other personnel designated and authorised by the Sponsor. 
The PI or institution provide direct access to source data during and after the performance study for Sponsor audits, CEC 
review and RA inspections. 
12 PUBLICATION AND COMMUNICATION 
The Sponsor retains ownership of the study results. However, the TSC will oversee the publication process to ensure 
adherence to the following principles –  
 
Authorship eligibility should be based on ICMJE criteria (substantial contributions, drafting/revision, approval, 
accountability). FIND encourages in-country partners to take the first authorship position, where appropriate, and 
generally prefers to be listed as the last author for FIND-supported projects. Study data should be submitted for journal 
publication within 12 months of completion unless otherwise specified by the TSC. All manuscripts reporting study data 

 
 
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should be published in an open-access, peer-reviewed journal, preferably with a CC-BY license. The target journal should 
be agreed upon by all authors in consultation with the TSC, with a focus on reputable journals and avoidance of 
predatory publishing practices. Any observed gender effects, or lack thereof, will be published in the CPSR and 
subsequent publications. Publications should be accurate, complete, balanced, and transparent, adhering to Good 
Publication Practice guidelines and Relevant reporting standards (e.g., CONSORT, PRISMA, STARD, and SAGER guidelines) 
should be consulted and followed. Clinical trial registration numbers should be included when available.  
 
FIND strives to limit FIND authors to a maximum of three people. FIND authors should preferentially be staff or de facto 
staff.  All FIND authors should disclose any relationships or potential competing interests, including their employment at 
FIND. Manuscripts should describe each author's role and acknowledge sponsorship and funding sources. 
The use of professional medical writers should be acknowledged. 
 
Copyright permissions should be obtained for any figures or tables from previously published articles. Embargoes set by 
journals or congresses must be respected.   
 
Study results will be communicated to study participants, healthcare providers, the public, and other relevant 
stakeholders, as guided by the TSC. 
 
13 FUNDING AND SUPPORT 
13.1 Funding 
Studies are funded through by the Canadian Government through the Department Of Foreign Affairs, Trade And 
Development (DFATD).  
14 INSURANCE 
This performance study involves minimal risk of injury to study participants and therefore insurance has not been 
obtained. The approval of the CEC will be sought for this. 
 
15 REFERENCES 
1. Peters, R. P. H. et al. Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in 
syndromic management settings: a cross-sectional performance evaluation. Lancet 403, 657–664 (2024). 
2. Multi-drug resistant gonorrhoea. https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-
gonorrhoea. 
3. Peters, R. P. H. et al. Cross-Sectional Study of Genital, Rectal, and Pharyngeal Chlamydia and Gonorrhea in Women in 
Rural South Africa. Sexually Transmitted Diseases 41, 564–569 (2014). 

 
 
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4. Gleeson, B. et al. Development of a Novel Fluorescent-Based Lateral Flow Assay for the Detection of Neisseria 
gonorrhoeae at the Point of Care. Sexually Transmitted Diseases 51, 186 (2024). 
5. Riddell, M. A. et al. 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. The Lancet Global Health 12, e641–e651 (2024).