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Peer-Reviewed Publication
Fertil Steril2017;107(2):358-364.e4.February 1, 2017Clinical Trial

Novel centrifugal technology for measuring sperm concentration in the home.

Ulrich Y Schaff1, Laura L Fredriksen1, Jon G Epperson1, Tiffany R Quebral1, Sara Naab1, Mark J Sarno2, Michael L Eisenberg3, Greg J Sommer4
1Sandstone Diagnostics, Inc., Livermore, California.
2Vision Biotechnology Consulting, Escondido, California.
3Department of Urology and Department of Obstetrics & Gynecology, Stanford University School of Medicine, Palo Alto, California.
4Sandstone Diagnostics, Inc., Livermore, California. Electronic address: gsommer@sandstonedx.com.
PubMed DOI

Abstract

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 se…

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