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PATIENT INFORMATION OF TRANSMISSABLE
DISEASES BY DONOR INSEMINATION


XYTEX CORPORATION
1100 EMMETT STREET
AUGUSTA, GA  30904 

Human semen may transmit infectious or genetic disease regardless of its evaluation prior to use in assisted reproduction, including artificial insemination. Xytex, through its screening procedures, substantially reduces the risk of transmissible disease but cannot guarantee absence of such risks to a woman using donor semen, as well as to her child.

To reduce the possibility of transmitting infectious diseases, Xytex obtains extensive personal, medical and social histories from each semen donor. These histories are updated semiannually. Semiannual testing of donors includes human immunodeficiency virus (HIV 1&2), human T-cell lymphotrophic virus (HTLV I & II), syphilis, hepatitis B & C, CMV, chlamydia, gonorrhea, and trichomonas. Only after repeatedly negative results are specimens released from quarantine and made available for shipment to physicians.

To reduce the risk of transmitting genetic diseases, Xytex obtains extensive medical and family histories from each donor. These histories are updated semiannually and each one is reviewed by a physician. When required, consultation is obtained from a board-certified clinical geneticist. Commercial laboratory tests are available for only a fraction of more than 5,000 genetic diseases, making comprehensive testing for genetic disease impractical. Screening is performed for selected genetic diseases and as warranted by a donor’s ethnic and racial background. It is important to note that screening of the semen donor does not reduce the risk of a woman transmitting genetic disease to her child.

Despite the intensive screening and quarantine process, Xytex cannot guarantee the donor sperm is free of infectious and genetic disease. The inherent, though minimal, inaccuracies of many laboratory tests do not allow exclusion of such risks. However, the repetitive and strict nature of the process is intended to produce the safest product possible.




To download your copy of The Complete FDA 1271 --
American Regulations for Human Reproductive Tissue Banks,
click here.

To download your copy of the FAQs about 21CFR Part 1271,
click here.

To download your copy of Federal Involvement in Reproductive Tissue Preservation for Women at Risk of Cytotoxic Sterility,
click here.

To download your copy of Women at Risk (Power Point presentation),
click here.


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