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.
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 Million/mL with Pearson and concordance correlation coefficient above 0.92. The YO [Home Sperm Test] 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%.
Comparison of the results of the YO devices with those of the SQA-Vision on the MSC threshold above and below 6 Million/mL is presented in Table 2. The PPA and NPA of the smartphones are further illustrated in a vertical scatterplot (Fig. 2). The results demonstrate accuracy above 97% for both the YO iPhone and YO Galaxy. The overall accuracy of both devices was 97.8%. The high PPA and NPA results indicate the ability of the YO device to accurately identify the MSC of semen samples above and below the threshold of 6 Million/mL. The overall false-positive cases were low for both YO devices (<3%).
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 Million/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. (Fertility & Sterility by ASRM.)