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Home Test Confirms Men's Post-Vasectomy Sterility

By Biotechdaily staff writers
Posted on 19 Mar 2008
Vasectomies are not 100% effective, and vasectomized men can experience recanalization, or the spontaneous healing or restoration of the vas deferens resulting in fertility. A test has been developed that can be used to monitor and confirm sterility following the vasectomy procedure, alerting couples should fertility become restored. In addition, the device could be used to monitor male infertility over time in the event that male contraceptive pills are successfully developed.

The device gives men an opportunity to test their post vasectomy fertility status at home rather than return to the physician's office or a laboratory with semen samples, as has traditionally been required to confirm sub-fertile sperm levels.

A gene (ACRV1) was identified that encoded a protein that could serve as a sperm-specific biomarker. The SP-10 protein is very soluble and highly expressed, making it an ideal target for diagnostic testing. The new device uses monoclonal antibodies that bind specifically to the SP-10 protein to measure the amount in nanograms of SP-10 protein, which directly correlates to the number of sperm present.

Called SpermCheck Vasectomy, the test was created using technology developed by Professor John C. Herr, director of University of Virginia's Center for Research in Contraceptive and Reproductive Health (Charlottesville, VA, USA). The test been approved by the U.S. Food and Drug Association (FDA; Rockville, MD, USA).

"The SpermCheck Vasectomy test is the result of many years of basic science research coupled with clinical chemistry know-how,” said Prof. Herr. "Similar to a home pregnancy test for women, it is the first immunodiagnostic test with the sensitivity and specificity required to detect low numbers of sperm, and it is the first immunodiagnostic test to receive FDA approval for monitoring sperm count after vasectomy.”


Related Links:
U.S. Food and Drug Association
University of Virginia's Center for Research in Contraceptive and Reproductive Health

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