Ashok Agarwal1, Manesh Kumar Panner Selvam2, Rakesh Sharma2, Kruyanshi Master2, Aditi Sharma2, Sajal Gupta2, Ralf Henkel3. 1. American Center for Reproductive Medicine, Cleveland Clinic, Cleveland, Ohio. Electronic address: agarwaa@ccf.org. 2. American Center for Reproductive Medicine, Cleveland Clinic, Cleveland, Ohio. 3. American Center for Reproductive Medicine, Cleveland Clinic, Cleveland, Ohio; Department of Medical Bioscience, University of the Western Cape, Bellville, South Africa.
Abstract
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.
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.
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