June 18, 2013

More Organ-Donor Testing is Advised


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Niraj Desai waits for a kidney to be removed from a donor at Johns Hopkins Hospital. More than 118,000 Americans are waiting for an organ transplant.

June 18, 2013, 7:29 p.m. ET


The federal government on Tuesday recommended expanding the number of diseases that organ donors should be screened for, adding hepatitis B and hepatitis C to the list, in an effort to cut down on infections that could unexpectedly occur when a person receives a transplant.

The guidelines released by the Department of Health & Human Services also recommend that a newer, more sensitive and faster test be used to screen for hepatitis as well as for HIV, the virus that causes AIDS, for which donor screening is already recommended.

Currently, even without the new guidelines, potential donors are routinely screened for hepatitis, though with older tests that take longer to produce results. But time is of the essence when it comes to organ transplants.

Organs harvested from deceased donors can only be used for a short period of time, and pathogens like HIV or hepatitis don't immediately show up on tests, evading detection for weeks, if not months. Tests with shorter turnaround times—like the ones recommended in the new guidelines—are better able to screen out infected individuals in time for a transplant.

The guidelines must still be adopted as policy by the federal agencies that contract with United Network for Organ Sharing to operate the national organ-transplantation system.

"We have to make these difficult decisions of what organs can be accepted for transplantation and what risks are acceptable," said Matthew Kuehnert, the director of the office of blood, organ and other tissue safety at the Centers for Disease Control and Prevention, which helped draft the guidelines.

The aim is to help physicians and patients make an informed choice about whether to go ahead with transplantation of a particular donated organ, and enable clinicians to track recipients after donation for signs of an emerging infection, Dr. Kuehnert said.

The number of transplants performed in the U.S. has risen 74% in the past two decades, to 28,051 in 2012 from 16,134 in 1992, according to UNOS. Kidneys, liver and hearts were the most commonly transplanted organs. Demand has increased from Americans needing kidney replacements due to diabetes, chronic hypertension and other illnesses, Dr. Kuehnert said.

Supply hasn't kept up. More than 118,000 Americans are on UNOS's waiting list for an organ transplant.

The new guidelines have some in the transplant community concerned because they could reduce the number of donors, since they might be labeled as having an increased risk for hepatitis, even though they aren't actually infected, said Michael G. Ison, medical director of Northwestern University's transplant infectious-disease service in Chicago. "There's a large deficit of organs," he said.

Only about 1% of all organ transplants lead to an unexpected infectious-disease transmission, the CDC said. But HIV, hepatitis B and hepatitis C have been reported to be unintentionally transmitted in heart, liver, kidney and pancreas recipients, according to the agency.

An estimated 72,000 Americans become infected with viral hepatitis every year, many of them baby boomers who don't realize they have the blood-borne infection. The CDC estimates about 1.2 million Americans have hepatitis B and 3.2 million are infected with hepatitis C.

The newer tests, known as NAT, for nucleic acid testing, detect infections very close to when donors contract them. Hepatitis C, for instance, can be identified 90% faster, from 77 days previously to just 7 days with the newer tests, Dr. Kuehnert said.

Write to Timothy W. Martin at timothy.martin@wsj.com and Laura Landro at laura.landro@wsj.com


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