United States Seeks New Hepatitis Blood Donation Rules

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5/22/08 CDC

UNITED STATES: " United States Seeks New Hepatitis Blood Donation Rules "

Reuters (05.20.08):: Heavey

The Food and Drug Administration on Tuesday released a draft guidance to blood

centers recommending that people who have repeatedly tested falsely positive for

hepatitis B, but who are subsequently found to be uninfected, be allowed to

donate blood. Currently, these people are indefinitely deferred from blood

donation.

FDA argues that better, more specific tests can now be used to determine whether

donors are actually infected. The older, less specific test that checked for

antibodies to hepatitis B core antigen, or anti-HBc, could sometimes lead to

false positive results.

According to the guidance, " Although it may seem unlikely that two anti-HBc

tests would be false positives, such situations have occurred with some

frequency because of the relative non-specificity of these tests. The result is

that many otherwise suitable donors are indefinitely deferred because of their

anti-HBc test results even though medical follow-up of such donors indicates

that they are not infected with HBV. "

" The availability of an FDA-licensed hepatitis B virus nucleic acid test (HBV

NAT) since October, 2004, which is particularly sensitive when single samples

are tested, provides an additional, powerful method of determining whether a

donor who has been deferred because of anti-HBc reactivity is truly infected by

HBV, " the agency said.

FDA estimates that as many as 21,500 potentially eligible donors were deferred

each year in the late 1980s and 1990s due to false positive anti-HBc results.

Blood organizations support the new draft guidance. " We hope this will bring

back donors who meet the criteria, " said Mack Benton of America's Blood Centers.

American Red Cross spokesperson Millian said her organization also

supports the change.

FDA is seeking public comments on the draft, which is posted on its Web site.

For more information, visit http://www.fda.gov/cber/gdlns/reentrybld.htm.

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