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