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Management and testing of donors
BioGenetics Corporation undertakes the most stringent donor selection and testing process in the U.S.
In addition, to a complete physical examination, prospective Donors are required to undergo psychological testing and evaluation by a licensed board certified independent Psychologist. These modalities are subject to change based on new regulatory standards and/or corporate policies.
The initial screening of Donors includes the following laboratory tests:
- Complete Semen Analysis
- Blood Group and Rh Factor
- Chemistry Profile
- Complete Blood Count (CBC)
- Chromosome Study (Karotyping)
- B-Thalassemia screening
- Cystic Fibrosis screening
- Tay Sachs screening
- Gaucher Disease screening
- Canavan Disease screening
- Sickle Cell Anemia screening
- Niemann-Pick Disease screening
- SMA (Spinal Muscular Atrophy disease)*
- Drugs of Abuse (Random Testing)
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- HIV-1/HBV/HCV NAT
- HIV 1 &2 Antibody
- HTLV I & II
- Hepatitis C Virus
- Hepatitis B Surface Antigen
- Hepatitis B Core Antibody
- Syphillis Serology (RPR)
- Cytomegalovirus Antibodies (CMV)
- Chlamydia PCR (Urine)
- Gonorrhea PCR (Urine)
- Ureaplasma (Culture)
- Mycoplasma (Culture)
- Herpes Antibodies screening
- Routine Bacteriological Culture (B-Strep)
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All BioGenetics Donors are subjected to repeat laboratory testing periodically based on the frequency of the donor's participation. Laboratory testing includes:
- HIV 1 & 2 Antibody
- HTLV I & II
- Hepatitis C Virus
- Hepatitis B Surface Antigen
- Ureaplasma (Culture)
- Cytomegalovirus Antibodies (CMV)
- Drugs of Abuse (Random Testing)
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- Syphillis Serology (RPR)
- Gonorrhea PCR (Urine)
- Chlamydia PCR (Urine)
- Herpes Antibodies screening
- Mycoplasma (Culture)
- Routine Bacteriological Culture (B-Strep)
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At the end of the quarantine period (180 days) and prior to the release of the inventoried Donor vials, Donors undergo additional laboratory testing including a physical examination.
Donors are tracked and tested for five (5) years after leaving the donor program, on a voluntary basis.
BioGenetics Corporation maintains all personal information from the Donors and the Client(s)/Recipient(s) as privileged and confidential, thus protecting the identity and anonymity of all parties involved.
* SMA testing limited to Donors recruited after 2008.
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2013 © BioGenetics™ Corporation | Changes may occur without prior notice. 
