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RecruitingNCT07569900Updated Sep 30, 2026

A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test

An interventional study of iStatis Gonorrhea Antigen Test in Gonorrhea Infection, sponsored by bioLytical Laboratories. Recruiting at 3 sites in South Africa. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by bioLytical Laboratories · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2025, registered Apr 2026).
  • Started Nov 2025; still recruiting 11 months later.
Updated Sep 30, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
650
Allocation
Randomized
Ages
16 Years and older
Sex
Female
01

Study 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 the detailed description

The study is designed to evaluate iStatis Gonorrhea Test performance when used by trained personnel as follows:

  1. 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.
  2. 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.
  3. 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.
02

Conditions studied

  • Gonorrhea Infection

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Keywords

  • Gonorrhea test
  • Point-of-care test
  • iStatis test
03

In context

Gonorrhea

167 studies on the registry are indexed under Gonorrhea; 31 are open to participants now.

This study's planned enrollment of 650 is above the median of 400 across 125 interventional studies indexed under Gonorrhea.

Browse Gonorrhea studies →

Lead sponsor

bioLytical Laboratories is the lead sponsor of 16 studies on the registry; 6 are open to participants now.

Browse bioLytical Laboratories studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > 16 years
  • Subject (or legally authorized representative) is willing to provide written 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
  • 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 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

Exclusion criteria

Exclusion Criteria

  • Subject 15 years of age or younger
  • Male gender
  • Female currently menstruating
  • Subject is unable or unwilling to provide
  • 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
  • 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
650 participants (estimated)

Study arms

  • Experimental
    iStatis Gonorrhea Test Performance (Operator-collected swabs)

    Operator-collected vaginal swabs will be tested on the iStatis Gonorrhea Test

    Device: iStatis Gonorrhea Antigen Test

  • Experimental
    iStatis Gonorrhea Test Performance (Self-collected swabs)

    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

    Device: iStatis Gonorrhea Antigen Test

  • No intervention
    Reference Test to evaluate iStatis Performance

    Vaginal swabs collected for reference testing will be tested using the Cobas CT/NG reference assay to determine the gonorrhea infection status of participants.

Interventions

  • DeviceiStatis Gonorrhea Antigen Test

    Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

07

Study locations

3 of 3 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.

Of 40 interventional studies with no phase under Gonorrhea, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 12 months is below that.

Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Sep 30, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2026
First posted
May 6, 2026
StartActual
Nov 26, 2025
Primary completionEst.
Dec 1, 2026was Sep 2026
CompletionEst.
Jan 1, 2027
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Sep 1, 2026→Dec 1, 2026
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Primary completion Sep 1, 2026→Dec 1, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07569900
Lead sponsor
bioLytical Laboratories
Collaborators
Epicentre
Responsible party
Sponsor
First posted
May 6, 2026
Start date
Nov 26, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Ana Subramanian
Contact
asubramanian@biolytical.com
16042046784
Patrick Diaz
Contact
pdiaz@biolytical.com
16042046784

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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