Point-of-care semen analysis of patients with infertility via smartphone and colorimetric paper-based diagnostic device

Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. However, men often feel too embarrassed to receive a semen analysis in the hospital due to social stigmas. To overcome this problem, we developed a 3-(4,5-Dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide test strip to distinguish semen samples with low total motile sperm concentration from those with normal motile sperm concentration. This is a point-of-care colorimetric semen analytical method with a one-step, inexpensive, equipment-free evaluation process, and adequate accuracy validated in a 42-sample clinical trial. In this study, results were evaluated visually and with a smartphone application. Using visual observation methods, the area under the curve (AUC) was 0.71 (95% of confidence interval = 0.55-0.86;p= 0.021), sensitivity was 41%, specificity was 95%, positive predictive value was 90%, negative predictive value (NPV) was 59.4%, and accuracy was 67%. Using a smartphone recording and analytical system, AUC was 0.766 (95% of confidence interval = 0.612-0.92;p= 0.003), sensitivity was 96%, specificity was 65%, PPV was 75%, NPV was 92.9%, and accuracy was 80.9%. This work demonstrated a screening tool that could elevate semen analysis to the level of routine healthcare and provide for private, in-home self-assessment.

Automated summary

This study developed a colorimetric semen analytical method that can distinguish semen samples with low total motile sperm concentration from those with normal motile sperm concentration. The method is one-step, inexpensive, and equipment-free, with validation in a 42-sample clinical trial. Visual evaluation and smartphone application were used to assess the results, showing potential for routine healthcare screening and private, in-home self-assessment.