The first known hepatitis C virus transmission via transplanted cardiopulmonary tissue occurred in September after a tissue bank misread the results of a genetic test of the tissue, the Centers for Disease Control and Prevention (CDC) has reported.
In the December 23 issue of its Morbidity and Mortality Weekly Report, the CDC said the transplant of infected tissue took place in a Massachusetts health facility just days before a recall of organs and tissue from the infected donor was issued. The recall was spurred by HCV infections detected in a 41-year-old man and a 46-year-old woman who received kidneys from the same donor.
The donor was a middle-aged Kentucky man who died in March 2011 from injuries sustained in an all-terrain vehicle crash. Antibody tests for hepatitis C virus by the organ procurement organization and the tissue bank had negative results. But a positive viral nucleic acid test performed by the tissue bank was mistakenly read as negative. The donor had no known risks for infection, but he had received 6 units of blood products shortly before he died. Samples of his blood taken before the transfusion weren’t available for analysis.
The CDC report noted that the Organ Procurement and Transplantation Network (OPTN), which oversees solid organ transplant policies and procedures, requires only antibody tests to detected hepatitis C virus infections. But the US Food and Drug Administration, which regulates the safety and effectiveness of human cells and tissues used in transplants, requires antibody and nucleic acid tests.
“Although correct reading of tissue donor nucleic acid test 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 hepatitis C virus serologic testing,” the authors wrote.
“A real-time system for notification of disease clusters in transplant recipients is needed to prevent further use of tissue that tests positive for hepatitis C virus or other infections,” they added.