Valentine’s Gift Idea! SpermCheck FERTILITY ! Home Test For Men indicates Normal or Low Sperm Count. @ BOOTS
Spermcheck® Fertility EASY AT-HOME TEST FOR SPERM COUNT
SpermCheck Fertility makes it easy and affordable for men to check their own sperm count quickly and discreetly at home, without the bother, embarrassment, and expense of a doctor’s visit. With thousands of tests sold worldwide since 2010, SpermCheck continues to be an essential tool for men trying to help their partners conceive. It is the only at-home male fertility test sold in Boots in the UK.
In 2010, SpermCheck was approved for the EU: CE mark approval CE0843. SpermCheck manufacturers hold the Full Quality Assurance System Approval Certificate indicating compliance under Annex IV, section 3 of Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices.
Test Overview
• SpermCheck Fertility measures the levels of SP-10 in a semen sample collected at home
• SpermCheck Fertility is the only FDA-approved home male fertility test that utilizes state-of-the- art lateral-flow immunoassay technology
• Results indicate normal or low sperm count
• Results are guaranteed accurate and ready to view in 7 minutes
• All components of the SpermCheck Fertility test are 100% made in the U.S.A
Scientific Papers for SpermCheck Fertility
• Coppola MA, Klotz KL, Kim K-a, Cho HY, Kang J, Shetty J. Howards SS, Flickinger CJ, and Herr JC. SpermCheck Fertility, an immunodiagnostic home test that detects normozoospermia and severe oligozoospermia. Hum Reprod2010; 00: 1-9.
• Bjorndahl L,Kirkman-Brown J, Hart G, Rattle S, Barratt CL. Development of a novel home sperm test. Hum Reprod2006; 21:145-149.
• Herr JC, Flickinger CJ, Homyk M, Lotz K, John E. Biotchemical and morphological characterization of the intra-acrosomal antigen SP-10 from human sperm. Biol Reprod 1990; 42:181-193
• Kurth BE, Klotz K, Flickinger CJ, Herr JC. Localization of sperm antigen SP-10 during the six stages of the cycle of the seminiferous epithelium in man. Biol Reprod 1991; 44:814-821.
• Kurth BE, Wright RM, Flickinger CH, Herr JC. Stage-specific detection of mRNA for the sperm antigen SP-10 in human testes. Anat Rec 1993; 236:619-625.
• Mankveld R, Wong WY, Lombard CJ, Wetzels AM, Thomas CM, Merkus HM, Steegers-Theunissen RP. Semen parameters, including WHO and strict criteria morphology, in a fertile and subfertile population; an effort towards standardization of invivo thresholds. Hum Reprod 2001; 16:1165-1171
Timeline
1992: ContraVac, Inc., the company that developed and obtained FDA approval for SpermCheck Fertility, was founded by Dr. John Herr, Ph.D., Director of the Center for Contraceptive and Reproductive Health at the University of Virginia
2010: Dr. Herr discovers SP-10, a sperm-specific antigen contained in the head of the sperm (acrosome) and obtains to U.S patents for
the antigen:
• Patent Number 5,436,157 – Human Intra-Acrosomal Sperm Antigen
• Patent Number 5,602,005 – Primate Intra-Acrosomal Sperm Antigen for Use in a Contraceptive Vaccine
2010: SpermCheck Fertility at-home test concept is developed and published in the journal Human Reproduction
2010–2018: SpermCheck Fertility is approved by the Food and Drug Administration (FDA) in 2010 and is successfully marketed online. It is the only male home fertility test in the retail space, and is sold at Walgreens, CVS, and Rite Aid in the U.S.A., and Boots in the UK
• FDA 510 (k) number K100341
2018: On May 1, ContraVac, Inc. is acquired by and becomes a subsidiary of DNA Diagnostics Center, Inc. (DDC). Initiatives begin to expand the reach of the SpermCheck Fertility product on Amazon as well as to a wider global market
• The test received CE mark approval CE0843 in 2010
• SpermCheck Fertility manufacturers hold the EC Certificate – Full Quality Assurance System Approval Certificate indicating compliance under Annex IV, section 3 of Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices
• SpermCheck Fertility is the only home male fertility test sold in Boots in the UK
