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Comprehensive Donor Screening
TSBC conducts a comprehensive donor screening process on all donors in full compliance with regulations set forth by the FDA and the states of California, New York, and Maryland (the only states that separately regulate reproductive tissue donation). We screen all sperm donors in accordance with parameters recommended by the American Society for Reproductive Medicine, the American Association of Tissue Banks, and the Centers for Disease Control and Prevention. We use only cryopreserved (frozen) semen, and all donor samples are quarantined for a minimum of six months before they are released, so that we may thoroughly screen donors for sexually transmitted diseases. For a listing of all the Screening Tests that we do and the Laboratories that we use please use the links below:
Clinical Evaluation of Donors Before Approval
- One complete semen analysis; three to five sperm counts and post-thaw evaluations.
- A three-generation medical and genetic history, self-reported during a personal interview (the medical history consists of the donor, their siblings, parents, and grandparents. Four generations are included if the donor has their own children). Read more about the importance of family health history
- HIV risk assessment interview, based on sexual activity and drug-use history.
- Blood and urine testing for infectious diseases: HIV-1/2/O, HTLV-1/2, hepatitis B, hepatitis C, syphilis, gonorrhea, chlamydia, CMV (cytomegalovirus), and West Nile Virus.
- Screening questionnaire to assess exposure to Zika Virus.
- Blood and urine testing for blood typing and general health indicators: ABO/Rh typing, CBC (complete blood count), liver panel, chemistry panel, and urinalysis.
- All donors receive genetic screening for Cystic Fibrosis carrier trait and for spinal muscular atrophy (SMA) carrier status. All donors are tested by Hemoglobin Electrophoresis to screen for Sickle-cell and Thalassemia carrier status and identify other hemoglobin-related blood disorders. Donors of Jewish, French-Canadian, or Cajun descent also receive genetic screening for Tay Sachs carrier trait. Starting in June 2021, new donors are tested using an expanded carrier screening panel. The specifics of each donor’s genetic testing is available for free through links on our donor catalog. Read more about our genetic screening
- Complete physical examination.
- Medical Director review of all screening and testing documents and all health related information reported by donor.
Clinical Evaluation of Donors After Approval
- A sperm count and post-thaw evaluation is performed on every sample to ensure that it meets our post-thaw minimum of 20 million motile sperm per cc.
- Quarterly testing for HIV-1/2/O, HTLV-1/2, hepatitis B, hepatitis C, syphilis, gonorrhea, chlamydia, CMV (cytomegalovirus), and West Nile Virus.
- Semi-annual update of medical history, genetic history, and HIV risk assessment.
- Semi-annual physical exam, including urinalysis, CBC, liver panel, and chemistry panel.
- Six months after the donor has provided a final semen sample, we perform exit testing for HIV-1/2/O, HTLV-1/2, hepatitis B, hepatitis C, syphilis, CMV, and West Nile Virus.