Q&A Reproductive Life Planning

FDA Blood Testing Requirements for Embryo Donors

FDA blood testing requirements for embyro donation

In the past several years, fertility clinics have begun requiring special FDA testing be done on embryo donors before donated embryo(s) can be transferred to a recipient family. In 2017, the FDA issued a clarifying statement on the exceptions to these rules that effectively permit the use of any embryos.

What does the FDA require? The FDA requirement states that a blood-test should be performed (when possible) on both the male and female donors to check for: HIV I & II, 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, and Rh factor.

Who needs to be tested? According to The Embryo Adoption Awareness Center,The FDA requires that parents who created embryos on or after May 25, 2005 must have their blood screened twice for infectious diseases. The first screen is done at the time of collection/creation and the second screen must be done at least six months later. This is to ensure that no infectious diseases were contracted during the month or two preceding the collection, which would not have shown up on the first screen.

Parents who created embryos before May 25, 2005 are recommended to have this second screening done, but there is no FDA requirement. However, most clinics who agree to accept embryos from other clinics will require a second screening, even if they embryos were created far before May 25, 2005.”

Why does the FDA require it be done? Prior to the creation of the embryos, these tests were run on the donors. So why do the tests need to be run again? The purpose of the second set of tests being 6 months after the creation of the embryo(s) is to rule out the contraction of a communicable disease prior to the creation of the embryos, but close enough to the first round of testing that it did not show up on the test. For example: If the donor was exposed to Gonorrhea one week before the donation, the first test would show a negative result, while the second test 6 months later would show a positive result.

There is some controversy over this. Some doctors feel that the chance of an embryo contracting the disease at this brief level of exposure and then further transmitting said disease to the recipient mother is so low it does not warrant these additional tests. Other doctors feel that any chance of transmission is too great, and the test should always be done.

To further complicate the issue, assuming the first test was negative and the second test was positive, it would be nearly impossible to determine if the communicable disease was transmitted prior to or after the creation of the embryo(s). If a donor tests positive for a communicable disease, it is still possible to use the embryos (see “exceptions” below).

Who can perform the tests?  Testing must be performed using an appropriate FDA-licensed, approved, or cleared donor screening test, according to the manufacturer’s instructions for us (IFU), in a CLIA-certified laboratory (Clinical Laboratory Improvement Amendments of 1988) or an equivalent facility as determined by CMS (Centers for Medicare and Medicaid Services).

How much do the tests cost? Depending upon the testing facility and insurance coverage, out-of-pocket cost typically range from $200 to $1,200.

Who pays for the testing? Fees for the screens are covered by the adopting parents, although donating parents may have to pay initially and then be reimbursed.

Are there exceptions? Can I sign a waiver to bypass the testing? According to Dr. Michelle McClure ( Office of Tissues and Advanced Therapies, CBER, FDA), in 2017 the FDA is providing greater accommodation of individuals and couple wanting access to embryos originally intended for reproductive use, while continuing to emphasize the applicability of the donor testing requirements. If an establishment fails to comply with the suggested FDA donors requirements, several exceptions allows the establishment to make the embryos available for reproductive use.

If an egg or sperm donor was used in the creation of the embryos before May 25, 2005, the original screening results are sufficient. It is not necessary to locate him or her for additional blood testing.

If the donating parents are not able or willing to complete additional blood testing, a waiver can be signed by the adoptive parents stating that they are aware of the lack of testing and choose to accept any risks. McClure cautions, “Again, just like with ineligible donors, in some of these scenarios you might have known or unknown risk factors and although the FDA permits the use of these embryos under this exception, there is still a decision the establishment and treating physician may want to make as far as whether they want to transfer these embryos into a recipient.”

McClure’s remarks above can be seen in this FDA webinar, Regulatroy Approach for Reproductive Cells and Tissues, at the 45;12 mark. She summarizes, “There is an FDA process in line to be able to use pretty much any embryos that have been created,” from the same webinar at the 45:50 mark.

 

Blog written by Charis Johnson, co-founder of NRFA.