Amid growing concern about disease transmission through organ transplants in the U.S., the Centers for Disease Control and Prevention on Wednesday issued new draft guidelines recommending that all donors be screened with a more sensitive test for infections including HIV and the hepatitis C and B viruses.
Though disease transmission is still relatively rare, the CDC says that from 2007 to 2010, it investigated more than 200 cases of suspected transmission of HIV, HBV and HCV through transplants; some confirmed cases led to the deaths of transplant recipients. In March, the CDC reported on HIV transmission from a live donor in New York. Organs can also transmit other viruses and bacteria.
Matthew Kuehnert, who oversees blood-transfusion and transplant safety at the CDC, says the new guidelines, which are open for public comment until Nov 21, "will improve patient safety, reduce unintended disease transmission and save lives."
The recommended screening method, known as nucleic-acid testing, or NAT, can detect an infection acquired seven days before testing. Standard blood tests, known as serologic testing, measure antibodies to an infection that may take months to appear. The new guidelines would replace current ones last updated in 1994, when the more sensitive tests weren't yet approved by the Food and Drug Administration.
In the case of living donors, the guidelines recommend that NAT screens should be performed as close to the time of organ recovery as feasible, but no longer than seven days before the organ is recovered from the donor. In the case of deceased donors, the test should be administered either before or, if timing allows, after procurement.
As of 2008, only about half the 58 organ-procurement organizations in the U.S. voluntarily performed NAT tests for HIV and HCV on all or at least some potential donors, according to the CDC.
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