Novel mobile-enabled point-of-care testing for comprehensive male fertility assessment
Reza Amin, PhD1, Jared Bieniek, MD2, Evelyn Neuber, PhD3.
1QRfertile, farmington, CT, 2Hartford Healthcare, Hartford, CT, 3Center for Advanced Reproductive Services, farmington, CT.
Novel mobile-enabled point-of-care testing for comprehensive male fertility assessment
Introduction: Semen analysis remains the gold standard for male fertility testing. The current standard is for men to visit a laboratory and either deliver a fresh semen sample or collect a sample on site for analysis. This process, however, is uncomfortable for most men, time-consuming, and costly. We have developed a mobile-enabled paper-based device for home-based male fertility testing of sperm concentration, semen pH, and semen fructose concentration; allowing men to make their initial male fertility assessments in the comfort of their homes. Here we present validation data for our novel home male fertility colorimetric testing assay.
Methods: The testing device comprises a reservoir for sample loading, sample delivery microfluidic channels, and a paper layer pre-loaded with colorimetric reagents. Sperm count is quantified by measuring the colorimetric change of yellow tetrazolium dye to purple formazan by metabolically active sperms. The color change in each assay region is imaged and analyzed using a mobile phone application. Human semen samples were obtained from a local fertility clinic (Farmington, CT) and applied to our device without any sample preparation. Measured semen parameters were compared to standard semen analysis results by trained andrologists.
Results: Previous sensitivity testing of eight different sperm concentrations (utilizing ten semen samples) was performed to create a calibration curve with (R2 = 0.97). Using the established calibration, the sperm concentration of seven new semen samples was evaluated in comparison to standard lab-based testing and a mean absolute error of 12M sperm was obtained. The pH sensitivity is increased by multiplexing of three pH indicators and their calibration curves have been determined and further tested in five semen samples with a mean absolute error of 0.45. The colorimetric fructose assay has been calibrated for concentrations ranging from 0 to 4 mg/mL (R2 = 0.98).
Conclusions: Our preliminary clinical validation demonstrates the practicality of the proposed at-home diagnostic platform as a screening tool for male fertility assessment. Further testing is needed to define the sensitivity of the assays and user-friendliness of the platform. Furthermore, additional semen parameters, such as DNA fragmentation, are being targeted for future iterations of the platform. 
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