What are the current FDA requirements for blood tests?

The U.S. Food and Drug Administration (FDA) has published regulations regarding human tissue donation that effects embryo donation and adoption. On May 25, 2004, the FDA published final rules addressing donor testing/ screening and good tissue practice. The FDA subsequently issued an interim final rule on May 25, 2005, which amended certain sections of those regulations. For additional information on the rule, visit the FDA's website.

Previously, the FDA rules exempted sexually intimate partners engaged in reproductive treatment, from infectious disease testing prior to the creation of their embryos, which were intended for the couple's own use. The interim final rule expanded this exemption, which now permits couples who were not originally screened for infectious disease to donate their cryo-preserved embryos to other couples. The regulations do suggest that attempts to test these donor couples should be made before the embryos are transferred to the recipient, but, when testing is not possible, the recipient should at least be advised of the potential communicable disease risk. Given that FDA regulations may change, you should be sure to understand what screening and testing requirements are in effect at the time of the donation.

When issuing the interim final rule, the FDA stated, "We are now adding a new exemption from screening and testing in Sec. 1271.90(a)(4) for cryo-preserved embryos that, while originally exempt from the donor eligibility requirement because the donors were sexually intimate partners, are later intended for directed or anonymous donation. When possible, appropriate measures should be taken to screen and test the semen and acolyte donors before transfer of the embryo to a recipient. This change reflects the fact that sexually intimate partners may decide to donate their cryo-preserved embryos long after their fertility treatments are completed. Because the embryos were intended for use in a sexually intimate relationship the donors would not have been required to be screened and tested for communicable disease agents at the time that oocytes and semen were recovered. The new provision recommends that appropriate measures be taken to screen and test the semen and oocyte donors before transfer of the embryo to the recipient, when possible.”

The current FDA mandated blood tests include:

    • HIV 1 and 2
    • HTLV I/II
    • Hepatitis B surface antigen
    • Hepatitis B Core Antibody (IgG/IgM)
    •  Hepatitis C Antibody
    •  RPR (Syphilis)
    •  CMV IgG/IgM
    •  Gonorrhea/Chlamydia culture
    •  Blood Typing
    •  Rh factor