Organs and tissue donated by a Kentucky man infected with the hepatitis C virus causes disease transmission to multiple organ recipients.
The Centers for Disease Control and Prevention (CDC) recently confirmed
that 2 patients tested positive for hepatitis C 6 months after receiving organ transplants from a Kentucky donor with the disease.
News of this recent HCV transmission may cause the Organ Procurement and Transplantation Network (OPTN) to require more rigorous testing for tissue designated for implantation. Unlike the FDA, the OPTN does not currently require screening for HCV by both antibody and nucleic acid test (NAT); OPTN just tests for the presence of the antibody in the tissue.
The donor’s NAT, a highly sensitive test used to detect the presence of HIV and hepatitis C virus, was negative for the hepatitis C antibody before the organs were transplanted, but the result proved to be a false negative. Researchers retested the specimens of the donated tissue at a tissue bank during the investigation and found the presence of HCV antibodies. A total of 3 organs, 1 cardiopulmonary patch, and 43 musculoskeletal grafts from the infected donor went to health care facilities in numerous states. The virus was only discovered after 2 of the organ recipients tested positive for the HCV infection, and the information was not shared in time to prevent implantation of the infected cardiopulmonary patch.
Of the 3 organs donated, both kidneys initially tested negative for the HCV virus, whereas the liver tested positive. The liver recipient was already infected with HCV and was able to accept an organ with the same virus. There were 15 recipients of the infected musculoskeletal tissue, and these patients were recommended to receive serologic testing and another NAT 6 months from the time of implantation.
The tissue was recalled on September 30, 2011. By December 16, 2011, test results showed that 14 of 15 recipients of the tissue were negative for HCV. Molecular comparison of the HCV strains of the donor with the 2 kidney recipients and the recipient of the cardiopulmonary patch suggested genetic relatedness and was indicative of a common source of infection—the donor from Kentucky.
Before the transplant, the FDA tested for the presence of both the antibody and the NAT for the musculoskeletal tissue, but misread the well on the HCV NAT test, leading to the reporting of incorrect results.
Organs slated for donation are regulated by the Health Resources and Services Administration, and tissue banks are overseen by the FDA. Currently, there is no established protocol for sharing information about potential problems with donor tissue and organs between these organizations. The CDC investigation called for the timely feedback of possible disease transmission in organ or tissue recipients to organ procurement organizations, tissue banks, public health authorities, and regulators.
According to Matthew J. Kuehnert, MD, director of the Office of Blood, Organ, and Other Tissue Safety at the CDC, the importance lies in sharing medical information at a more accelerated rate. Dr. Kuehnert told The Boston Globe
, “There are ways that we can make these transplants safer. It’s only with the support of the public saying that we need to do this that we can progress.”
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