Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products (Guidance)

The Policy

What it does

Offers donor screening recommendations to reduce the risk of Zika virus transmission through human cells, tissues, and cellular and tissue-based products.


The Food and Drug Administration (FDA) has issued a list of donor screening recommendations to reduce the risk of Zika virus transmission through human cells, tissues, and cellular and tissue-based products (HCT/Ps) (noticed via the Federal Register, 81 FR 11808, published on March 7, 2016). Guidelines include:

  • Medical records (§ 1271.3(s)) must indicate a potential HCT/P donor is free from risk factors or clinical evidence of the Zika virus.
  • Living donors are ineligible if, within the past six months, they experienced any of the following risk factors:
    1. Medical diagnosis of Zika virus;
    2. Residence in or travel to area with active Zika virus transmission;
    3. Sex with a male who has either of the risk factors from items 1 or 2, above.
  • Donors of umbilical cords, placentas, or other gestational tissues should be ineligible if the birth mother, at any point in her pregnancy, has experienced the above risk factors.
  • Non-heart beating cadaveric donors should also be ineligible if the donor had a medical diagnosis of Zika virus within the past 6 months.

Zika virus is deemed a relevant communicable disease agent or disease (RCDAD; § 1271.3(r)(2)). To make this determination, the FDA considers (1) risk of transmission, (2) severity of effect, and (3) availability of appropriate screening measures or tests. This designation subjects the Zika virus to guidance originally created in August, 2007, and titled “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” 

The Science

Science Synopsis

  • The Zika virus is contracted primarily through an infected Aedes mosquito bite, but can also be spread through mother to child transmission, sexual transmission, and blood transfusion.
  • The most common symptoms of Zika are fever, rash, joint pain, or conjunctivitis (red eyes). Other common symptoms include muscle pain and headache. Infection does not necessarily confer demonstration of symptoms.
  • The incubation period, or time between exposure and symptoms, is unknown, but is thought to be between a few days and a week.
  • Zika virus poses an especially dangerous threat to pregnant women, as it is associated with microcephaly, a condition in which a baby’s head and brain are abnormally small and the brain does not properly develop. This can lead to cognitive impairment, vision and hearing problems, seizures, and other brain-related impairments.
  • Zika virus is also associated with Guillain-Barré Syndrome (GBS), a nervous system condition that can lead to muscle weakness or temporary paralysis.
  • The CDC developed the first commercial test to detect whether a person has been infected by the Zika Virus (Zika MAC-ELISA). This test must be conducted between 2 and 12 weeks post infection.  The MAC-ELISA test has the potential to identify a false positive if antibodies from a similar virus (dengue or chikungunya) are present.  The test can indicate a false negative if the sample is collected more that 12 weeks after the infection, or if antibody concentration is too low. Relevant samples include serum and cerebrospinal fluid.
  • The CDC also developed the Trioplex rRT-PCR laboratory test, which is designed to detect Zika virus and two other viruses (dengue and chikungunya) also spread by mosquito bites. This test must be conducted within 7 days of onset of symptoms.  The test is designed to have a low false positive rate. However, false negatives are also possible for this test; a negative result does not rule out infection by Zika. Samples from this test can be gathered from urine, cerebrospinal fluid, serum or amniotic fluid.
  • There is currently no cure or vaccine for Zika virus.