Sexually Transmitted Diseases
Conditions
Brief summary
This is a multi-center study in which the performance of the Visby Medical Men's Sexual Health Test is evaluated when run by male subjects of 14 years of age and older on self-collected first catch urine samples using the audio-visual instructions provided by the Visby App and/or written instructions provided by the printed User Instructions.
Interventions
DIAGNOSTIC_TESTVisby Medical Men's STI PCR Test Kit
The Visby Medical Men's STI PCR Test is a single use (disposable), automated PCR (Polymerase Chain Reaction) in vitro diagnostic self-test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. This test is intended to be sold over the counter (OTC) for use by males suspected of sexually transmitted infection with Chlamydia trachomatis and Neisseria gonorrhoeae.
Sponsors
Visby Medical
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to provide written informed consent and/or assent as required by the reviewing IRB or IEC. Experimental Bill of Rights will also be documented for all study subjects enrolled in applicable states. * ≥14 years of age at the time of enrollment. * Subject has a penis at the time of enrollment. * Able to read and understand instructions provided for the study. * Willing and able to follow all study procedures, including performing self-collection of one urine sample, running the sample on a Visby test, and using the Visby App to interpret the test results.
Exclusion criteria
* Have a medical condition, serious illness, or other circumstance that, in the investigator's judgment, could jeopardize the subject's safety, or could interfere with study procedures. * Have consumed oral or intramuscular or intravenous antibiotics, within 48 hours prior to enrollment. * The subject has urinated within the last one (1) hour prior to urine sample collection. * Have an in-dwelling catheter or practices intermittent catheterization for urinary drainage. * Have been previously enrolled in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | up to 12 months | Evaluate the performance of the Visby test when run by male subjects ≥ 14 years of age, on self-collected first catch urine sample using the audio-visual instructions provided by the Visby App and/or written instructions provided by the printed User Instructions. |
Countries
United States
Outcome results
None listed