Amateur Versus Professional Users of the YO® Home Sperm Test: An Assessment of Usability

Objectives To assess the accuracy of home-test use by a real-world / amateur user. Methods This multi-site study investigated whether amateur users could use the FDA cleared YO® Home Sperm Test to obtain accurate MSC results when compared to trained laboratory technicians. The qualitative motile sperm concentration (MSC) results of amateur and professional YO users were compared to each other as well as to the results of an established automated sperm quality analyzer (SQA-V above and below a 6m/mL MSC cut-off). Results This was a blinded, prospective study of 316 amateur users and 3 professional laboratory technicians across 3 study sites. Amateur vs. Professional YO users demonstrated accuracy of >97%. Qualitative results of amateurs and professionals vs. SQA-V results showed >95.7% accuracy. Conclusion Amateur users with no prior training were able to follow the YO test directions to receive highly accurate qualitative MSC results. The YO test is user-friendly and can be used as an effective initial home screening tool to gain preliminary insight into the fertility status of the male in a real-world setting. Furthermore, the YO test results correlated with those obtained by the FDA cleared SQA-V laboratory analyzer, confirming that the YO test delivers accurate MSC results in the hands of amateur users.