Transmission of Hepatitis C Virus Through Transplanted Organs and Tissue

Kentucky and Massachusetts, 2011

Michael R. Marvin, MD; Melissa Steele; Doug Thoroughman, PhD; Tennis J. Sugg, MPH; Kraig E. Humbaugh, MD; Louise E. Vaz, MD; Sandra K Burchett, MD; Kristin Moffitt, MD; Carrie F. Nielsen, PhD; Scott D. Holmberg, MD; Jan Drobeniuc, MD; Yury Khudyakov, PhD; Matthew J. Kuehnert, MD; Susan N. Hocevar, MD

Disclosures

Morbidity and Mortality Weekly Report. 2011;60(50):1697-1700. 

In This Article

Editorial Note

The transmission of HCV associated with transplanted organs and minimally processed tissue has been described previously, but this is the first recognized HCV transmission via a cardiopulmonary patch.[4] Although correct reading of tissue donor NAT screening results would have prevented transmission through the tissue patch, the organ recipients still would have become infected because current OPTN policies for organ donor screening only require HCV serologic testing.[1] Furthermore, positive organ donor NAT screening likely would have resulted in quarantine of potentially infected tissue. Use of NAT, in addition to anti-HCV serologic testing, has been proposed to decrease the risk for transmitting undetected HCV infection. However, no one test can uniformly detect all infections, either because of false-negative tests resulting from the window period, or assay-related issues, or, as described in this report, because of human error.

Without information regarding a donor's behavioral risk factors, the assay selection and sensitivity of pretransplantation testing is critical. The incidence of HCV infection not detected by serologic screening for anti-HCV antibody varies from 1 in 5,000 for normal-risk patients to 1 in 1,000 for patients at high risk.[5] The window period (i.e., the time from exposure to detectable HCV antibody) has a mean of 65–70 days; this period is shortened to 3–5 days with use of NAT.[6] A transplant facility's decision to use an organ is based on the organ procurement organization's assessment of the donor's risk status and on test results.[5] Multiple factors, including the urgent need for a potentially life-saving transplant and informed consent of the transplant candidate must be considered when determining whether benefits of transplantation outweigh the risk for transmitting HCV. The U.S. Public Health Service recently drafted guidelines recommending testing of all organ donors with NAT for HCV regardless of risk status.[7] Even if test results are not available at the time of transplantation, results still can be used afterward to guide recipient evaluation and treatment.

The diagnosis of HCV infection in two recipients of kidneys from the same donor should raise immediate suspicion of donor-derived infection and reporting to OPTN and to local and state health departments as required by policy. Reporting to local and state health departments also should occur because acute HCV infection is a nationally notifiable disease. Reporting of suspected new diagnoses in organ recipients, including to tissue banks, should occur without delay, because such diagnoses might have implications for tissues that have not yet been transplanted.

The events in this report demonstrate the importance of timely communication once a transplant transmission is suspected and the difficulty of tracking tissue to the patient or provider level should a potential transmission be recognized after tissue has been distributed. Although FDA requires that the tissue bank track the distribution of tissues down to the institutional level, no government regulations require tracking tissue to the patient level; hospitals are asked voluntarily to return a record, often a postcard, to the tissue bank to notify them of implantation of the tissue. Many health-care facilities have a mechanism to track tissue to the patient, although approaches are not standardized.[8] Systems that facilitate real-time notification of possible disease transmission to tissue banks, organ procurement organizations, and other transplant centers do not exist, and development is hindered by the lack of standardized tissue nomenclature and identification standards.[9,10]

This investigation reveals several areas in which current detection and notification might be improved to prevent similar future transplant transmission events, including: 1) consideration of the use of HCV NAT for organ donors; 2) use of algorithms or other procedures to ensure accurate reading of test results and reduce human error; and 3) timely feedback of possible disease transmission in organ or tissue recipients to organ procurement organizations, tissue banks, public health authorities, and regulators.

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