SEMEN DONOR SCREENING GUIDE

Xytex takes the health of our donors and our recipients seriously. Before being approved, every potential donor is required to complete a comprehensive Medical History Questionnaire(MHQ). The questionnaire includes questions regarding the health of the donor and the donor’s blood relatives.* Also included are questions for high risk behaviors, questions developed by the U.S. Centers for Disease Control and Prevention (CDC). Any affirmative answer to the CDC questions automatically disqualifies a potential donor. All questionnaires are reviewed by the Xytex Medical Director.

If a donor’s MHQ is acceptable, the donor is screened, but not specifically tested, for certain diseases and behaviors based on information provided to Xytex on the MHQ. The following testing is completed on all donors:

• physical examination for evidence of sexually transmitted disease
• initial lab testing, including:
• complete blood count
• blood typing
• HIV 1 & 2 antibody testing
• HIV/HCV NAT (as of 05-25-05)
• Hepatitis B surface antigen
• Hepatitis B core antibody testing
• Hepatitis C antibody testing
• cytomegalovirus antibody testing (total). If total is positive, then IgG & IgM are tested **
• syphilis serology (RPR and TP-PA)
• HTLV I & II antibody screening
• full genital culture which includes testing for gonorrhea
• urine PCR testing for chlamydia and gonorrhea
• and urine testing for trichomonas

Xytex strives to perform genetic testing in a thoughtful and rational manner for common and relevant diseases.

Xytex provides the following genetic testing for all donors:

• Cystic Fibrosis
• Chromosome Analysis (karyotype)
• Hemoglobinopathies including sickle cell and thalassemia (for all donors joining the program as of 10/26/07)
• Tay Sachs (for all donors joining the program as of 4/28/08)
• Spinal Muscular Atrophy (for all new donors joining the program as of 12/10/08)

Additional genetic testing is performed depending on the ethnic background of donors (African-American, Jewish, Mediterranean):

• Sickle Cell
• Thalassemia (alpha and beta)
• Canavan
• Gaucher
• Fanconi Anemia (Jewish)
• Familial Dysautonomia (Jewish)
• Niemann-Pick (Jewish)

Genetics is very complicated and testing can only reduce but does not eliminate the risk of a donor being a carrier of a particular condition. For example, there are more than 1,300 known mutations of the cystic fibrosis gene. Since 2005, testing has included the 97 most common mutations. Donors tested prior to 2005 were screened for fewer mutations. Please view the donor's basic profile, under comments, for the # of tested mutations.

In addition, at each semen donation, the donor is asked the following questions. If he answers yes, he is referred to the Donor Counselor and if needed, the medical director, for further evaluation.

1. Do you have a new sexual partner?
2. Have you engaged in any high risk behavior?
3. Have you had a fever with a headache for a week, been diagnosed with West Nile, encephalitis or meningitis?
4. Have you had any urethral discharge or ulcers, genital warts or a contagious skin disease?

All Xytex donors have been screened for symptoms of West Nile Virus and SARS at each donation and on the medical history questionnaire.

As long as the donor continues to participate in the program, he is required to repeat lab testing at a minimum of six-month intervals for HIV 1 & 2, Hepatitis B, Hepatitis C, cytomegalovirus, syphilis, HTLV I & II, gonorrhea, chlamydia and trichomonas.

He is also required to update his medical history and to have a physical examination every six months. At this time he is asked about the occurrence of any new disease within his family. If there is a change in status, the donor’s profile is updated with the new information. The questionnaire itself is updated as necessary to ensure that Xytex is in compliance with new regulations or Xytex company policies.

*It is important to note that the medical history provided by the donor is not validated by reviewing the donor’s or his family’s private medical records.

**Xytex tests each donor for Cytomegalovirus (CMV), an extremely common virus that nearly every adult has at one time or another. You will note the appropriate icon beside each donor to reflect his CMV IgG status. Whether the icon indicates positive or negative does not qualify or disqualify the donor.  Xytex accepts samples from a donor with an IgG positive result which indicates a non-active CMV infection. An IgM positive result indicates an active CMV infection and the donor is considered unacceptable. Xytex recommends that you discuss the CMV status of your donor with your doctor if you have any questions or concerns.