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Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy

2008; Lippincott Williams & Wilkins; Volume: 180; Issue: 6 Linguagem: Inglês

10.1016/j.juro.2008.08.045

1527-3792

Kenneth L. Klotz, Michael A. Coppola, Michel Labrecque, Victor M. Brugh, Kim Ramsey, Kyung-ah Kim, Mark R. Conaway, Stuart S. Howards, Charles J. Flickinger, John C. Herr,

Reproductive Health and Technologies

No AccessJournal of UrologyAdult Urology1 Dec 2008Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomyis accompanied bySeptins as Diagnostic Markers for a Subset of Human Asthenozoospermia Kenneth L. Klotz, Michael A. Coppola, Michel Labrecque, Victor M. Brugh, Kim Ramsey, Kyung-ah Kim, Mark R. Conaway, Stuart S. Howards, Charles J. Flickinger, and John C. Herr Kenneth L. KlotzKenneth L. Klotz Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia , Michael A. CoppolaMichael A. Coppola ContraVac, Inc., Charlottesville, Virginia , Michel LabrecqueMichel Labrecque Université Laval, Quebec, Canada , Victor M. BrughVictor M. Brugh Devine-Tidewater Urology, Virginia Beach, Virginia , Kim RamseyKim Ramsey Devine-Tidewater Urology, Virginia Beach, Virginia , Kyung-ah KimKyung-ah Kim Princeton BioMeditech Corp., Princeton, New Jersey , Mark R. ConawayMark R. Conaway Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia , Stuart S. HowardsStuart S. Howards Department of Urology, University of Virginia, Charlottesville, Virginia , Charles J. FlickingerCharles J. Flickinger Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia , and John C. HerrJohn C. Herr Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia View All Author Informationhttps://doi.org/10.1016/j.juro.2008.08.045AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Compliance with post-vasectomy semen analysis could be improved with the availability of a simple, rapid and accurate home test. SpermCheck Vasectomy®, a highly sensitive lateral flow immunochromatographic diagnostic device, was designed to detect extreme oligospermia or azoospermia in men after vasectomy. We report the results of clinical and consumer testing of SpermCheck. Materials and Methods: A prospective, noncomparative observational study assessed the ability of SpermCheck Vasectomy to predict post-vasectomy sperm counts obtained using a hemacytometer procedure based on standard World Health Organization methodology. Consumer studies evaluated ease of use. Results: A cohort of 144 post-vasectomy semen samples was tested in the clinical trial. SpermCheck was 96% accurate in predicting whether sperm counts were greater or less than a threshold of 250,000 sperm per ml, a level associated with little or no risk of pregnancy. Sensitivity was 93% (95% CI 79% to 98%) and specificity was 97% (91% to 99%). The positive predictive value of the test was 93% (79% to 98%), and most importantly the negative predictive value was 97% (91% to 99%). The test gave a positive result 100% of the time at sperm concentrations of 385,000/ml or greater. Consumer studies with 109 lay volunteers showed that SpermCheck was easy to use. Volunteers obtained the correct or expected test result in every case and the correct response rate on a 20 question survey about the test was 97%. Conclusions: SpermCheck Vasectomy, a simple and reliable immunodiagnostic test that can provide evidence of vasectomy success or failure, offers a useful alternative to improve compliance with post-vasectomy sperm monitoring. It is currently the only Food and Drug Administration approved test for this purpose. References 1 : General and anomalous sperm disappearance characteristics found in a large vasectomy series. Fertil Steril1989; 51: 859. Google Scholar 2 : A prospective study of time and number of ejaculations to azoospermia after vasectomy by ligation and excision. J Urol2003; 170: 892. Link, Google Scholar 3 : Postvasectomy semen analysis: are men following up?. J Am Board Fam Pract2005; 18: 44. Google Scholar 4 : Patient noncompliance after vasectomy. Fertil Steril1997; 68: 552. Google Scholar 5 : The high rate of noncompliance for post-vasectomy semen examination: medical and legal considerations. J Urol1990; 144: 284. 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A Retrospective Descriptive StudyJournal of Urology, VOL. 206, NO. 1, (109-114), Online publication date: 1-Jul-2021.Punjani N, Andrusier M, Hayden R, Dudley V, Matos-Vargas E and Goldstein M (2021) Home Testing May Not Improve Postvasectomy Semen Analysis ComplianceUrology Practice, VOL. 8, NO. 3, (337-340), Online publication date: 1-May-2021.Sharlip I, Belker A, Honig S, Labrecque M, Marmar J, Ross L, Sandlow J and Sokal D (2012) Vasectomy: AUA GuidelineJournal of Urology, VOL. 188, NO. 6S, (2482-2491), Online publication date: 1-Dec-2012.Related articlesJournal of Urology24 Oct 2008Septins as Diagnostic Markers for a Subset of Human Asthenozoospermia Volume 180Issue 6December 2008Page: 2569-2576 Advertisement Copyright & Permissions© 2008 by American Urological AssociationKeywordsvasectomyspermatozoacytologysperm countinstrumentationAcknowledgmentsAnnie Goulet, Martin Laforest and Ann Villeneuve from PROCREA Cliniques, Québec, Canada (www.procrea.com) provided study assistance.Metrics Author Information Kenneth L. Klotz Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia Financial interest and/or other relationship with ContraVac, Inc. More articles by this author Michael A. Coppola ContraVac, Inc., Charlottesville, Virginia Financial interest and/or other relationship with ContraVac, Inc. More articles by this author Michel Labrecque Université Laval, Quebec, Canada Financial interest and/or other relationship with ContraVac, Inc. More articles by this author Victor M. Brugh Devine-Tidewater Urology, Virginia Beach, Virginia More articles by this author Kim Ramsey Devine-Tidewater Urology, Virginia Beach, Virginia More articles by this author Kyung-ah Kim Princeton BioMeditech Corp., Princeton, New Jersey More articles by this author Mark R. Conaway Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia More articles by this author Stuart S. Howards Department of Urology, University of Virginia, Charlottesville, Virginia Financial interest and/or other relationship with ContraVac, Inc. More articles by this author Charles J. Flickinger Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia Financial interest and/or other relationship with ContraVac, Inc. More articles by this author John C. Herr Department of Cell Biology and Center for Research in Contraceptive and Reproductive Health, University of Virginia, Charlottesville, Virginia Financial interest and/or other relationship with ContraVac, Inc. More articles by this author Expand All Advertisement PDF downloadLoading ...