New rapid testing methods needed to detect HCV in organ donors
CDC. MMWR. 2011;60:1697-1700.
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Problems with testing led to transmission of hepatitis C virus from a deceased organ donor to two kidney recipients and one tissue recipient in Kentucky during 2011, according to a recent Morbidity and Mortality Weekly Report.
“HCV antibody testing alone might not be adequate to detect disease in organ donors with recent infection; HCV [nucleic acid testing (NAT)] screening for organ donors should be considered to prevent such transmissions,” Reena Mahajan, MD, a CDC epidemic intelligence service officer, told Infectious Disease News.
“Also, word about possible risk for disease transmission was not received by one surgeon implanting tissue until after the vessel had already been implanted, resulting in further infection. Without a real-time communication network, implantation of infected tissue occurred after recognition of the infected kidney recipients.”
Health care facilities, the tissue bank and the CDC were notified of three potential transplant-related HCV infections on Sept. 29 after HCV was confirmed in three patients 6 months after receiving kidney and tissue transplants.
The CDC investigation aimed to identify potential sources of the donor’s infection, the mode of transmission, and to ensure timely notification of the implanting surgeons and testing of tissue recipients.
Results indicated that the donor had tested negative for HCV antibody by the organ procurement organization before transplantation. “Because the donor likely was recently infected, the antibody test did not detect infection,” Mahajan said. In addition, the donor had a positive nucleic acid test, which was incorrectly read, she said. The infected HCV tissue was implanted after new HCV infection was recognized in the transplant recipients.
“This report highlights the limitation of HCV antibody testing; nucleic acid testing of all organ donors could have prevented these transmissions described in our investigation,” Mahajan said. “Also, there is a need to ensure accurate and appropriate testing of organ and tissue donors, and more rapid communication of suspected disease transmission.”
Disclosure: The researchers report no relevant financial disclosures.
Unexpected transmission of HCV and other infectious diseases from infected organ and tissue donors can result in serious morbidity and death in recipients who are often heavily immunosuppressed. Although recent improvements in diagnostics such as NAT testing have mitigated some of the risk involved, there are several challenges that remain. The first is the heterogeneity of testing practices among US transplant centers. Expert guidelines to reduce transmission are dated (> 15 years old), rely on risk-based screening, and are focused only on prevention of transmission of HIV via tissues and organs. Given that Organ Procurement and Transplantation Network (OPTN) policies only require anti-HCV serology testing for organs, not all centers have adopted the more sensitive HCV NAT testing which can reduce the window period to 3-5 days from 65-70 days with serology. On the other hand, although the FDA (and not OPTN) requires both HCV serology and NAT testing for all donated tissue, human error resulted in distribution of infected tissue samples. A current Draft Guideline prepared by the CDC and an expert panel will recommend HCV NAT testing of all potential solid organ donors, regardless of known behavioral risk. These guidelines (which also incorporate recommendations for preventing HIV and HBV transmission in transplantation) have recently closed for public comment. Another important issue that this report highlights is the rapid and complex coordination that is needed once a potential disease event is suspected. In this report, one HCV-infected donor could have potentially infected three organ and 44 tissue recipients dispersed geographically. The establishment of the Disease Transmission Advisory Committee (DTAC) by OPTN and the United Network for Organ Sharing has led to more rapid and coordinated testing and treatment of potentially infected recipients and communication between transplant centers. Continuing to improve this system to one that is real-time and standardized across all organ and tissue donation centers will continue to ensure that organ and tissue transplantation remain safe.
- Peter Chin-Hong, MD
Infectious Disease News Editorial Board member
Disclosure: Dr. Chin-Hong reports no relevant financial disclosures.
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