A clinical study of the Medical Electronic System’s YO Home Sperm Test Kit was featured in the American Society of Reproductive Medicine (ASRM’s) Fertility and Sterility publication for December 2018.
Objective
To test the ability of the smartphone-based YO Home Sperm Test to accurately and precisely measure motile sperm concentration (MSC) versus the SQA-Vision, an automated laboratory semen analyzer.
Design
MSC compared for the YO device on Galaxy and iPhone smartphones versus the SQA-Vision in a double-blind manner.
Setting
Academic medical center.
Patient(s)
Donor semen samples from 24 men in 144 aliquots.
Intervention(s)
None.
Main Outcome Measure(s)
Accuracy, precision, and agreement assessed between the YO device and the SQA-Vision for MSC results.
Result(s)
The YO device demonstrated good correlation and good to moderate agreement with the SQA-Vision for MSC results up to a range of 94 × 106/mL with Pearson and concordance correlation coefficient above 0.92. The YO also showed a very high level of accuracy (97.8%) with positive and negative percent agreement above 94%. The difference in coefficient of variation between the YO and the SQA-Vision was low (between 9.4% and 11.2%) and not statistically significant. The precision among the YO phone devices was lower (16.0%) than the manufacturer’s claim of ≤20%.
Conclusion(s)
The smartphone-based device has a high level of accuracy and precision when compared with the SQA-Vision. It can detect samples with abnormally “low” MSC (below 6 × 106/mL cutoff), which supports its use as an effective home sperm test for screening “low” and “moderate/normal” MSC cases. In addition, the device effectively identifies varying levels of normal MSC in a precise manner over a wide range of normal MSC. Thus, the YO results can improve patient satisfaction and empowerment.