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
Visby Medical
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.
Eligibility
- Age range
- 14+ years
- Sex
- Male
- 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.…
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.
Location
- University of Washington, Virology Research ClinicSeattle, Washington