FDA Proposes End to Hepatitis B Surface Antigen Test Requirement for Donated Blood

Original from: 360dx

To the cheers of blood centers, the US Food and Drug Administration said this week that it plans to eliminate a requirement to screen donated blood with hepatitis B virus surface antigen testing when two other testing methods are also used.

The agency said in draft guidance that hepatitis B surface antigen tests are not necessary to reduce the risk of hepatitis B transmission from donated whole blood and blood components when those donations are screened using nucleic acid tests and core antigen tests. However, the agency recommends the continued use of surface antigen tests on source plasma donations, which are not screened using anti-hepatitis B core antigen tests.

Agency officials said that research results show that nucleic acid tests are effective for the detection of acute or ongoing hepatitis B infections while core antigen tests are effective for the detection of chronic or occult hepatitis B infection.

America's Blood Centers, a trade group of community-based blood centers, said that the draft guidance would reduce unnecessary regulatory burdens on blood centers by eliminating a requirement for a duplicative test. The risk of hepatitis B virus transmission is already appropriately reduced by the other two required tests, and halting surface antigen testing could reduce annual costs to blood centers of an estimated $15 million to $22.5 million, it said.

"We call upon FDA to continue to examine options to remove unnecessary, outdated, and burdensome requirements on blood centers, including other testing requirements that fail to increase the safety of the nation’s blood supply," America's Blood Centers CEO Kate Fry said in a statement.

The FDA noted that scientists from the American Red Cross had published in 2013 and 2018 the results of studies on the use of a three-test screening system for the detection of hepatitis B, and it said that those results showed that eight out of about 35.1 million donations screened by the American Red Cross from July 2009 through June 2015 had negative results for hepatitis B from nucleic acid and core antigen tests and positive results from a hepatitis B surface antigen test. Two of those positive results were determined to be false positives, and the other six donations likely contained extremely low to negligible amounts of hepatitis B virus DNA.

Source: FDA Proposes End to Hepatitis B Surface Antigen Test Requirement for Donated Blood