The Food and Drug Administration regulates the donation of eggs and other tissues under Chapter 21 of the Code of Federal Regulation Parts 1270 and 1271. Under this law, the FDA requires prospective egg donors to be evaluated using specific criteria to determine their risk for transmission of communicable diseases to the recipient. In addition to the federal requirements, some donor agencies and assisted reproductive technology facilities have added other voluntary screening criteria.
Pass a Risk-Factor Screening Questionnaire
Prospective egg donors are asked questions about risky social behavior and exposure to infectious diseases to assess the donor's potential to spread disease through egg donation. The FDA requires that egg donors answer questions about high-risk social behavior. For example, donors are asked if they have ever engaged in prostitution, injected illegal drugs or engaged in high-risk sex practices like having sex with HIV-infected persons or persons who inject street drugs.
Donors are also asked about exposure to communicable diseases including hepatitis B and C, syphilis, chlamydia, gonorrhea, Creutzfeldt-Jakob disease or West Nile virus. Donors are asked about their travel to and time spent living in countries outside of the U.S. that have a higher risk for exposure to infectious diseases like AIDS and mad cow disease. A physician or other health care professional is required to collect additional information about any concerning responses and make a medical judgment about whether the prospective egg donor is eligible to donate.
Pass a General Physical Exam
The next screening mandated by federal law is a physical examination to look for signs of high-risk behaviors and possible infection, such as tattoos, drug injection scars or genital warts. The examining physician or nurse must make a medical judgment regarding findings from the general exam and other medical records. For instance, tattoos received at a licensed facility would be considered low risk compared to jailhouse tattoos.
Pass Blood Tests
Federal law requires that egg donors have negative blood tests for HIV types 1 and 2, Hepatitis B virus, Hepatitis C virus, syphilis, chlamydia and gonorrhea. The FDA mandates that specific FDA-licensed test kits are used for each test. The frequency of testing and when testing must be performed relative to the time of egg donation is also regulated by the FDA. An initial positive test can't be repeated with a second confirmatory test, but it immediately disqualifies a prospective donor. Only FDA-registered testing facilities are permitted to perform tests to determine donor eligibility.
Pass a Voluntary Screening
The FDA limits its interest in donor screening to preventing the transmission of infectious diseases. The American Society for Reproductive Medicine has published guidelines recommending additional screening that facilities may require of prospective donors. For instance, donors may be asked to provide a three-generation family medical history to screen for genetic disease. Donor screening facilities may include genetic testing on prospective donors in certain ethnic groups that are at higher risk for particular inheritable diseases. Prospective egg donors may be asked to submit to psychological screening to rule out emotional or mental problems.
