Validation of a Novel Smartphone-Based Point-of-Care Semen Analysis System to Evaluate Male Reproductive Potential: A...

Background/Objectives: Male factor infertility contributes to approximately 40-50% of infertility cases globally, yet traditional laboratory-based semen analysis often imposes logistical and psychological barriers. This study aimed to evaluate the analytical performance and diagnostic concordance of a novel smartphone-based point-of-care testing (POCT) system, Hagobogo Pro, compared with a laboratory-based computer-assisted sperm analysis (CASA) reference system. Methods: This retrospective validation study analyzed 520 video microscopy clips obtained from 104 men undergoing infertility evaluation at a tertiary fertility center. Following World Health Organization (WHO) 2021 guidelines, sperm concentration and total motility were measured using the Hagobogo Pro smartphone device and the reference system. Analytical performance was assessed based on intra-assay precision, operational time, and method agreement using Passing-Bablok regression, Bland-Altman analysis, and Spearman correlation. Results: The smartphone-based system demonstrated strong analytical agreement with the CASA reference, with high correlations observed for sperm concentration (ρ = 0.943) and motility (ρ = 0.7335). Bland-Altman analysis indicated minimal systematic bias, and intra-assay precision showed coefficients of variation below 6%. There were no statistically significant differences in mean parameters between the smartphone device, CASA, and manual assessment. Conclusions: The Hagobogo Pro platform enables rapid, reliable, and standardized sperm concentration and motility quantification, and results showed good agreement with laboratory CASA. While not a replacement for holistic laboratory evaluations, this technology improves access to preliminary male fertility screening and may empower patients by mitigating barriers to initial testing.