ABSTRACT
OBJECTIVE: To assess the accuracy of the YO home sperm test by real-world/amateur users. METHODS: This multisite study investigated whether amateur users could use the FDA-cleared YO Home Sperm Test to obtain accurate motile sperm concentration (MSC) results when compared to trained laboratory technicians. The qualitative 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 6 m/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 an accuracy of >97%. Qualitative results of amateurs and professionals vs SQA-V results showed a >95.7% accuracy. CONCLUSION: Amateur users with no prior training were able to follow the YO test directions to receive highly accurate qualitative motile sperm concentration (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.
