Public Relations/Public Education Council

Talking Points: Relative Risk of Infectious Disease Transmission in Organ Donation

On November 12, 2007, health officials reported that four patients at three Chicago transplant centers received organ transplants from a local organ donor who was HIVand HCV positive. All routine and required screening and laboratory serological testing of the donor were completed by the organ procurement organization (OPO) prior to transplantation and the results were negative. Post-transplant, Nucleic Acid Amplification Testing (NAAT) determined that the donor was HIVand HCV positive, a diagnosis which may have gone undetected  due to the donor being exposed to HIV only weeks prior to the donation. This is the only time HIV has been transmitted via organ transplantation since 1985.

·         Federal laws, regulations and guidelines; state laws and regulations; and voluntary industry standards address procedures for the safe recovery and transplantation of organs and tissues.

·         The Food and Drug Administration’s (FDA) Good Tissue Practices (GTP) rule specifies the minimum conditions, timing, types of tests, and associated procedures required for testing specimens in determining the absence or presence of transmittable diseases.

·         OPOs conduct extensive medical and social interviews to the greatest extent practical during screening. Screening assesses the quality of the organs and identifies risks of transmissable diseases.

·         While standard laboratory serological tests are highly accurate, there is a small window through which a virus can infect a patient only months before organ donation and therefore elude detection.

·         Nucleic Acid Amplification Testing (NAAT) for HIV and HCV are licensed by the Food and Drug Administration. These newer tests are able to detect the genetic material of a transfusion-transmitted virus like HIV without waiting for the body to form antibodies. NAAT tests are not required to be performed by organ procurement organizations and are not widely available, costly and carry a high risk for false positives.

·         The United Network for Organ Sharing (UNOS) policy regarding donor screening sets the minimum standards for organ procurement organizations, including “any new conditions identified by the Centers for Disease Control and Prevention (CDC) as being a potentially communicable disease.”

·         OPOs are required to conduct the following serological testing on all organ donors: HIV, Hepatitis B and C, VDRL/RPR (syphilis), HTLV (which may cause T-cell leukemia and T-cell lymphoma), CMV (primarily transmitted in utero but can be opportunistic in immunocompromised patients), and Epstein-Barr virus. Some OPOs, particularly those with large Latin American immigrant populations, test for Chagas disease.

·         Based on the results of the medical and social screening, OPOs may need to conduct additional testing for West Nile Virus, Chagas, and other diseases, and, if the results are inconclusive or appropriate testing is unavailable, they may rule out the patient as an organ donor.

·         There have been more than 300,000 organ transplants since the CDC issued its guidelines for preventing the transmission of HIV through organ and tissue transplantation in 1994.  Fewer than 30 transplants (0.01%) involved transmission of a disease that was not identified prior to recovery and transplant.  This is the only case that involved HIV.

·         Transplant centers, OPOs and the CDC recognizes that a patient’s risk of dying without a transplant is often much higher than the possible risk of acquiring a disease.

For more information contact:

Joni Rosebrock

Chairman, 2006-2007 AOPO PR/PE Council

Manager of Public Education, Indiana Organ Procurement Organization

317-685-0688 x3511

jonir@iopo.org