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The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with Chlamydia trachomatis and Neisseria gonorrhoeae in males.

The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully automated, rapid, compact device that contains PCR assays for qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) DNA in male urine samples from symptomatic or asymptomatic individuals. The device automatically performs all steps required to complete lysis, PCR amplification, and detection.

The Visby Medical Men's Sexual Health Test is designed to be simple to use. When combined with a user-provided urine collection cup and a Visby power adapter accessory, the test contains all the materials required to perform the test. The patient collects a first catch urine sample in a standard urine collection cup (not provided). The operator starts the test by using a provided fixed-volume disposable transfer pipette to transfer ~ 450 µL of urine from the collection cup into a dropper tube containing ~900 µL of Visby Medical Men's Sexual Health Buffer. The operator transfers the entire volume (~1.35 mL) of the sample (urine in buffer) into the sample port of the device by squeezing the dropper tube to release all of the sample into the device sample port. The operator then slides a purple switch on the front of the device to both close the sample port and initiate the fully automated testing process. At this point, blinking white lights on the front of the device indicate the test is in progress. Test results are available in just under 30 minutes at which time a green "READY" status light will appear at the bottom of the device, and a purple color will appear in the "RESULTS VALID" spot, indicating a valid test. A purple spot adjacent to "CHLAMYDIA" and/or "GONORRHEA" signifies the presence of amplified CT and/or NG DNA in the sample.

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