Gonorrhea InfectionNCT07569900
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
A study testing iStatis Gonorrhea Antigen Test in people with Gonorrhea Infection, run by bioLytical Laboratories at 3 sites in South Africa.
Trial summary
The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gonorrhea Infection
- What is being tested?
- iStatis Gonorrhea Antigen Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 26 Nov 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age > 16 years
- Subject (or legally authorized representative) is willing to provide written informed consent before any study procedures
- Female gender
- Subject is able and willing to provide vaginal swab specimen for study procedures (3-4 swabs)
- Subject can complete the required testing on the allocated testing day
- Subject can speak, read, and write English
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- Subject's demographic information, risk factors, and symptoms are available and can be recorded on case report forms
- Subject agrees to comply with study procedures and sample collection for both the investigational device and the reference method
- Subject is willing to participate in the study site's standard-of-care Gonorrhea counselling and testing program and receive standard-of-care test results, as required and applicable
- Subject is indicated for sexually transmitted infection testing for one or more of the following reasons:
- At risk of Gonorrhea, such as recent unprotected intercourse, multiple or new partners within < 60 days, known exposure to an infected partner, or prior STI history
- Having signs and/or symptoms suggestive of Gonorrhea (e.g., urethral, vaginal, rectal, or pharyngeal discharge; dysuria; pelvic or lower-abdominal pain; sore throat; or rectal discomfort)
- Undergoing routine or opportunistic STI screening, including family-planning, antenatal, or sexual-health clinic visits
- Undergoing re-testing (test-of-cure) > 7 days after completion of Gonorrhea treatment and clinically stable
- Undergoing co-testing for other STIs where Gonorrhea testing is part of a broader diagnostic panel
Who cannot join
- Subject 15 years of age or younger
- Male gender
- Female currently menstruating
- Subject is unable or unwilling to provide informed consent
- Subject is medically unstable or has psychiatric condition(s) that pose a risk or prevent study compliance
- Subject is unable to provide paired samples for reference testing
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- Subject requires urgent antimicrobial treatment before specimen collection
- Subject received systemic or topical antibiotics active against Gonorrhea within the previous 7 days
- Subject used topical intravaginal or rectal antiseptics within 48 hours prior to study sampling
- Previously enrolled for the same infection episode
- Anatomical or clinical contraindication to study sampling (e.g., severe cervical pathology)
- Recent urogenital procedure (e.g., cystoscopy, lavage) < 72 hours before study sampling
- Subject belongs to a protected group excluded by local ethics (e.g., incarcerated persons), unless explicitly approved by the EC/IRB
- Any condition that, in the opinion of trained personnel or study staff, would make the participant unsuitable or unsafe for enrolment, interfere with completion of assessments, consent, or questionnaires, or bias study outcomes
- Subject is participating in another interventional clinical study within 30 days that could interfere with study results
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa3 sites, 3 recruiting
- Recruiting
Epicentre Health Research (Cape Town)
Cape Town, Western Cape, 7925
Cherie Cawood, +27 21 201 1658, cheriec@epicentre.org.za
- Recruiting
Epicentre Health Research
Durban, KwaZulu-Natal, 3650
Cherie Cawood, +27 31 880 2150, cheriec@epicentre.org.za
- Recruiting
Epicentre Health Research (Johannesburg)
Johannesburg, Gauteng, 2193
Cherie Cawood, +42 082 065 2172, cheriec@epicentre.org.za
About this study
Official title: A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test by Trained Personnel at Near-Patient or Point-of-Care Settings
The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel.
Read the detailed description
The study is designed to evaluate iStatis Gonorrhea Test performance when used by trained personnel as follows:
- A method comparison will be performed to determine the diagnostic sensitivity and specificity of the iStatis Gonorrhea Test compared to a reference test that is an approved, current on-market Gonorrhea/Chlamydia combo assay, Cobas CT/NG.
- To evaluate the usability of iStatis Gonorrhea Test by means of assessing user experience via a questionnaire in combination with the success in performing the test. A minimum of 15 intended users to participate in the usability evaluation.
- To evaluate and document whether intended users (trained personnel), a minimum of 15 intended users across a minimum of three (3) sites, can successfully interpret contrived iStatis Gonorrhea Test results that include - strong positive, weak positive, negative and a range of invalid results.
- Conditions
- Gonorrhea Infection
- Being tested
- iStatis Gonorrhea Antigen Test
- Keywords
- Gonorrhea test, Point-of-care test, iStatis test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStatis Gonorrhea Antigen TestDevice
Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test
| Study group | Role | What they receive |
|---|---|---|
| iStatis Gonorrhea Test Performance (Operator-collected swabs) | Experimental | Operator-collected vaginal swabs will be tested on the iStatis Gonorrhea Test Receives: Device: iStatis Gonorrhea Antigen Test |
| iStatis Gonorrhea Test Performance (Self-collected swabs) | Experimental | Self-collected vaginal swabs will be tested on the iStatis Gonorrhea Test. Participants assigned to the self-collection arm of the study will complete the self-collection Usability Questionnaire Receives: Device: iStatis Gonorrhea Antigen Test |
| Reference Test to evaluate iStatis Performance | No intervention | Vaginal swabs collected for reference testing will be tested using the Cobas CT/NG reference assay to determine the gonorrhea infection status of participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Evaluation
The performance between iStatis Gonorrhea Test and the reference test result for vaginal swabs (operator-collected and self-collected) will be calculated for all sites combined. Diagnostic sensitivity and specificity values and 95% CIs will be calculated for all subjects combined. The percentage of invalids (tests that fail to produce a control dot with accurate use) will be identified and reported.
Measured: 3 months
Secondary outcomes (2)
iStatis Gonorrhea Test usability evaluation
Overall test usability and self collection usability will be determined via a questionnaire completed by trained personnel who used the device during testing and study participants that performed sample self-collection respectively. The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.
Measured: 3 months
iStatis Gonorrhea Test contrived result interpretation evaluation
Trained operators will evaluate a panel of contrived (mock) iStatis devices. These devices are designed to represent a comprehensive range of test outcomes, including strong positives, weak positives, negatives and invalid results. Operators will interpret the results of the mock devices and record their interpretations which will be compared to the correct interpretation of the device.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start26 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonorrhea InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Epicentre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569900
- Sponsor's protocol ID
- CLS-009A
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test by Trained Personnel at Near-Patient or Point-of-Care Settings
- ClinicalTrials.gov ID
- NCT07569900
- Acronym / sponsor ID
- CLS-009A
- Conditions
- Gonorrhea Infection
- Keywords
- Gonorrhea test, Point-of-care test, iStatis test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Epicentre
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel.
Detailed description
The study is designed to evaluate iStatis Gonorrhea Test performance when used by trained personnel as follows:
- A method comparison will be performed to determine the diagnostic sensitivity and specificity of the iStatis Gonorrhea Test compared to a reference test that is an approved, current on-market Gonorrhea/Chlamydia combo assay, Cobas CT/NG.
- To evaluate the usability of iStatis Gonorrhea Test by means of assessing user experience via a questionnaire in combination with the success in performing the test. A minimum of 15 intended users to participate in the usability evaluation.
- To evaluate and document whether intended users (trained personnel), a minimum of 15 intended users across a minimum of three (3) sites, can successfully interpret contrived iStatis Gonorrhea Test results that include - strong positive, weak positive, negative and a range of invalid results.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iStatis Gonorrhea Test Performance (Operator-collected swabs) | Experimental | Device: iStatis Gonorrhea Antigen TestOperator-collected vaginal swabs will be tested on the iStatis Gonorrhea Test |
| iStatis Gonorrhea Test Performance (Self-collected swabs) | Experimental | Device: iStatis Gonorrhea Antigen TestSelf-collected vaginal swabs will be tested on the iStatis Gonorrhea Test. Participants assigned to the self-collection arm of the study will complete the self-collection Usability Questionnaire |
| Reference Test to evaluate iStatis Performance | No intervention | –Vaginal swabs collected for reference testing will be tested using the Cobas CT/NG reference assay to determine the gonorrhea infection status of participants. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Age > 16 years
- Subject (or legally authorized representative) is willing to provide written informed consent before any study procedures
- Female gender
- Subject is able and willing to provide vaginal swab specimen for study procedures (3-4 swabs)
- Subject can complete the required testing on the allocated testing day
Key exclusion criteria (15 listed)
- Subject 15 years of age or younger
- Male gender
- Female currently menstruating
- Subject is unable or unwilling to provide informed consent
- Subject is medically unstable or has psychiatric condition(s) that pose a risk or prevent study compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iStatis Gonorrhea Antigen TestVaginal swabs are tested on the iStatis Gonorrhea Antigen Test | Device | iStatis Gonorrhea Test Performance (Operator-collected swabs), iStatis Gonorrhea Test Performance (Self-collected swabs) |
Primary outcome
Performance Evaluation
Time frame: 3 months
The performance between iStatis Gonorrhea Test and the reference test result for vaginal swabs (operator-collected and self-collected) will be calculated for all sites combined. Diagnostic sensitivity and specificity values and 95% CIs will be calculated for all subjects combined. The percentage of invalids (tests that fail to produce a control dot with accurate use) will be identified and reported.
2 secondary outcomes
iStatis Gonorrhea Test usability evaluation
Time frame: 3 months
iStatis Gonorrhea Test contrived result interpretation evaluation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iStatis Gonorrhea Antigen Test in people with Gonorrhea Infection, run by bioLytical Laboratories at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Subramanian (16042046784, asubramanian@biolytical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Evaluation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.