Clinical Evaluation of Visby Medical Men's Sexual Health Test

Clinical Evaluation of Visby Medical Men's STI PCR Test for Detection of Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) From Urine in an at Home Setting

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.

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.