Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy
Received 26 March 2008 published online 20 October 2008.
Refers to article:
Septins as Diagnostic Markers for a Subset of Human Asthenozoospermia
, 24 October 2008
Yoshio Sugino, Kentaro Ichioka, Takeshi Soda, Masafumi Ihara, Makoto Kinoshita, Osamu Ogawa, Hiroyuki Nishiyama
The Journal of Urology
December 2008 (Vol. 180, Issue 6, Pages 2706-2709) Abstract |
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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.
gPrinceton BioMeditech Corp., Princeton, New Jersey
Correspondence: Department of Cell Biology and Center for Contraceptive and Reproductive Health, P.O. Box 800732, University of Virginia Health System, Charlottesville, Virginia 22908-0732
Study received institutional review board approval.
Supported by National Institutes of Health Grant U54 29099, Fogarty International Center Grant D43 TW/HD 00654 and research contracts from ContraVac, Inc. (to JCH) with manufacturing and development expenses underwritten by Princeton BioMeditech Corporation.
For another article on a related topic see page 2706.
⁎ Financial interest and/or other relationship with ContraVac, Inc.
ABSTRACT