Clinical Evaluation of Visby Medical Men's Sexual Health Test

The study population will consist of subjects with a penis ≥14 years of age who are symptomatic or asymptomatic for sexual transmitted infections (STIs). Subjects will be classified as symptomatic if they report unusual urethral discharge, painful urination, testicular or scrotal pain/swelling, increased urinary frequency, pain or bleeding during sex/intercourse within 7 days prior to enrollment.

To better represent the end users of this product, subjects not actively seeking health care will be recruited into the study with the goal that ~30% of subjects would fall in this category.

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.