Home sperm testing device versus laboratory sperm quality analyzer: comparison of motile sperm concentration.

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 Score can improve patient satisfaction and empowerment.