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Donor and Specimen Testing

IDANT donors are actively recruited from the 130 colleges and universities of the New York-New Jersey metropolitan region. Ultimately, only 5-10% of all applicants screened are accepted in our donor program as a result of the screening process. 

All anonymous donors and their semen is fully tested in accordance with the current New York State Department of Health regulations, the American Association of Tissue Banks Standards, and Health Canada Directives utilizing FDA-licensed test kits.

The following tests are performed on all our donors:

HIV-1
HIV-2
HTLV-I
HTLV-II
Hepatitis C
Hepatitis B surface antigen
Hepatitis B core antibody
Syphilis (Non-treponemal and Treponemal specific)
CMV (IgG and IgM)
Chlamydia
Complete Blood Count
Chemistry Panel (ALT value)
Complete Physical Examination

If applicable, the following genetic tests are performed:

Tay-Sachs Disease (for Jewish or French Canadian donors only)
Canavan Disease (for Jewish donors only)
Thalassemia (for donors of Mediterranean origin)
Sickle-Cell Disease (for African / African American donors only)
Cystic Fibrosis (if indicated in donor's family history)

In addition, every donor specimen is tested for the following:

Semen Analysis
Gonorrhea
Semen Culture & Sensitivity

The tests below are repeated every three months.  All anonymous donor semen are quarantined for at least 180 days:

HIV-1
HIV-2
HTLV-I
HTLV-II
Hepatitis C
Hepatitis B surface antigen
Hepatitis B core antibody
Syphilis (Non-treponemal and Treponemal specific)
CMV (IgG and IgM)
Chlamydia
Gonorrhea
Semen Culture & Sensitivity
ALT value

 

Quality of Donor Semen

Post-thaw motility
40% or greater
Motile sperm per straw
12.5 M or greater for ICI units / 5 M or greater for IUI units
Forward progression
3 or greater
%Normal morphology
14% or greater by Strict Criteria

Specimen Composition

Anonymous donor semen is either stored in 0.5ml straws as standard insemination units with minimum dilution for intra- cervical insemination units (ICI), or processed further using a gradient medium for intra-uterine insemination units (IUI).

The concentration of motile sperm varies between ejaculates and donors. Minimum cut-off levels as to motility, morphology, concentration, and cryosurvival are employed for each ejaculate.

IUI units are processed with Isolate, a two-layer gradient system that effectively isolates highly motile sperm cells from dead sperm, white blood cells, and cellular debris by density centrifugation and resuspended in modified human tubal fluid media that has been prepared in accordance with in vitro diagnostic guidelines and the Current Good Manufacturing Practices (cGMPs). All insemination units are cryopreserved with 10% v/v glycerol or a cryopreserved media composed of 12% glycerol, egg yolk, and buffer.

  

 

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