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.
Study Type
OBSERVATIONAL
Enrollment
507
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.
AHF Wellness Center - Broward
Fort Lauderdale, Florida, United States
Healthcare Clinical Data Inc.
Miami Lakes, Florida, United States
AHF Wellness Center - Peachtree
Atlanta, Georgia, United States
CrescentCare Sexual Health Center
New Orleans, Louisiana, United States
Primary Objective
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.
Time frame: up to 12 months
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University of Washington, Virology Research Clinic
Seattle, Washington, United States