Progress in developing an immunochromatographic device for sperm detection

Abstract

To our knowledge SpermCheck I represents the first immunodiagnostic device that has been developed to rapidly measure sperm in a platform suitable for both physician office and over-the-counter testing. At the time of this writing, the prototype device is poised to undergo clinical testing to gain the necessary performance data for the FDA approval process. The successful development of the working prototype establishes the proof of concept that immunodiagnostic devices of sufficient sensitivity can be developed to create products useful for male infertility as well as contraception and post-asectomy cases.

The impact of these devices on the practice of urology and infertility may be wide. Significant cost saving will occur in shifting the paradigm for sperm testing from laboratory microscope to a handheld immunodiagnostic device for home use. When infertility is suspected in a couple, these devices may well reduce unnecessary testing of women by provid- ing privacy to men and encouragement to them to assess male fertility status early in the diagnostic process. Further, follow- ing vasectomy, the SpermCheck I test will indicate when to discontinue other methods of contraception and prevent unanticipated pregnancy. The development of the SpermCheck I immunodiagnostic test parallels efforts underway by several organizations to develop a male “pill.” By virtue of its ability to determine when sperm counts have fallen to very low levels, SpermCheck I provides a companion test for men considering using a male contraceptive. Eventual availability of SpermCheck devices may help to hasten the general acceptance of male methods of contraception and contribute to equitable contraceptive responsibility between men and women.