Objective: To evaluate the analytical performance and usability of the Trak Male Fertility Testing System, a semiquantitative (categorical) device recently US Food and Drug Administration (FDA)-cleared for measuring sperm concentration in the home by untrained users.
Design: A three-site clinical trial comparing self-reported lay user results versus reference results obtained by computer-aided semen analysis (CASA).
Setting: Simulated home use environments at fertility centers and urologist offices.
Patient(s): A total of 239 untrained users.
Main outcome measure(s): Sperm concentration results reported from self-testing lay users and laboratory reference method by CASA were evaluated semiquantitatively against the device's clinical cutoffs of 15 M/mL (current World Health Organization cutoff) and 55 M/mL (associated with faster time to pregnancy). Additional reported metrics include assay linearity, precision, limit of detection, and ease-of-use ratings from lay users.
Result(s): Lay users achieved an accuracy (versus the reference) of 93.3% (95% confidence interval [CI] 84.1%-97.4%) for results categorized as ≤15 M/mL, 82.4% (95% CI 73.3%-88.9%) for results categorized as 15-55 M/mL, and 95.5% (95% CI 88.9%-98.2%) for results categorized as >55 M/mL. When measured quantitatively, Trak results had a strong linear correlation with CASA measurements (r = 0.99). The precision and limit of detection studies show that the device has adequate reproducibility and detection range for home use. Subjects generally rated the device as easy to use.
Conclusion(s): The Trak System is an accurate tool for semiquantitatively measuring sperm concentration in the home. The system may enable screening and longitudinal assessment of sperm concentration at home.
Clinical trial registration number: ClinicalTrials.gov identifier: NCT02475395.
Keywords: Sperm count; cytometry; home test; male fertility; semen analysis.
Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.