Actively Recruiting
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
Led by bioLytical Laboratories · Updated on 2026-05-06
650
Participants Needed
3
Research Sites
57 weeks
Total Duration
On this page
Sponsors
B
bioLytical Laboratories
Lead Sponsor
E
Epicentre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 16 years
- Female gender
- Willing and able to provide written informed consent
- Able and willing to provide vaginal swab specimens (3-4 swabs)
- Able to complete required testing on allocated testing day
- Can speak, read, and write English
- Demographic information, risk factors, and symptoms are available for recording
- Agrees to comply with study procedures and sample collection for both the investigational device and reference method
- Willing to participate in standard-of-care Gonorrhea counseling and testing program and receive standard-of-care results
- Indicated for sexually transmitted infection testing due to risk factors, symptoms suggestive of Gonorrhea, routine screening, re-testing after treatment, or co-testing for other STIs
You will not qualify if you...
- Age 15 years or younger
- Male gender
- Currently menstruating
- Unable or unwilling to provide informed consent
- Medically unstable or psychiatric condition posing risk or preventing compliance
- Unable to provide paired samples for reference testing
- Requires urgent antimicrobial treatment before specimen collection
- Received systemic or topical antibiotics active against Gonorrhea within previous 7 days
- Used topical intravaginal or rectal antiseptics within 48 hours before sampling
- Previously enrolled for the same infection episode
- Anatomical or clinical contraindication to study sampling (e.g., severe cervical pathology)
- Recent urogenital procedure within 72 hours before sampling
- Belongs to protected group excluded by local ethics unless approved
- Any condition making participation unsuitable, unsafe, or likely to bias results
- Participating in another interventional clinical study within 30 days that may interfere with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Epicentre Health Research (Johannesburg)
Johannesburg, Gauteng, South Africa, 2193
Actively Recruiting
2
Epicentre Health Research
Durban, KwaZulu-Natal, South Africa, 3650
Actively Recruiting
3
Epicentre Health Research (Cape Town)
Cape Town, Western Cape, South Africa, 7925
Actively Recruiting
Research Team
A
Ana Subramanian
CONTACT
P
Patrick Diaz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
3
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