Introducing a New Smartphone Applied Semen Analyzer, SpermCell™: A Cross-Sectional Validation Study with a Comparative Analysis and a Mini Patient Questionnaire on a Large Sample Cohort

Abstract

(1) Background: Standard semen analysis methods may exhibit variability between observers and/or human error; therefore, additional methods are needed to overcome these handicaps. We aimed to present a new smartphone-applied semen analyzer, Sperm Cell™, investigate its diagnostic efficacy by comparing it with the standard analysis method, and determine its user-friendly nature. (2) Methods: A cross-sectional study was conducted on a large sample cohort, including 102 men. Three semen analyses were performed for each semen sample. The first employed the standard manual method, whereas the others were smartphone-based analyses performed by technicians and patients. We compared major semen parameters between the three semen analyses. The user-friendly nature of the analyzer was also evaluated with a mini-questionnaire completed by the participants. (3) Results: The determined median sperm count, motile sperm count, and percentage of motile sperms, on standard manual semen analysis, were 50.00 × 106/mL (0–160 × 106/mL), 23.94 × 106/mL (0–108 × 106/mL) and 50.00% (0–73.00%), respectively. Median sperm count and motile sperm count were 50.52 × 106/mL (6/mL) vs. 55.77 × 106/mL (6/mL) and 23.34 × 106/mL (0–105 × 106/mL) vs. 23.53 × 106/mL (0–104 × 106/mL) for SpermCell™-based semen analysis performed by a technician and patients themselves, respectively. The percentages of motile sperms were 47.40% (0–67.00%) vs. 47.61% (0–80.20%), respectively. All the parameters were statistically similar between the three semen analysis methods (p > 0.05 for each). The SpermCell™ analysis results were correlated with the standard manual method with up to 0.85 correlation coefficients. Moreover, substantial diagnostic accuracy, sensitivity and specificity were obtained in determining the oligospermia and asthenozoospermia via the device-based analyses performed by technician and patients. The mini-questionnaire results revealed that the analyzer is useful. (4) Conclusions: The novel smartphone-applied semen analyzer is a helpful tool with acceptable diagnostic accuracy in determining the major semen parameters. It can be used as an efficient at-home point-of-care testing method in the initial assessment of couples with infertility concerns.

Keywords

• medical device
• point-of-care testing
• smartphone
• semen analysis
• validation study