Testing for hepatitis B surface antigen in processing donor tissue for penetrating keratoplasty.

Abstract

The Food and Drug Administration recently proposed a change in the screening of eye bank cornea donors for hepatitis B virus. Currently, most eye banks run confirmatory tests to reduce the frequency of false-positive hepatitis B virus surface antigen (HBsAg) tests. The Food and Drug Administration is considering a policy that would not allow confirmatory testing. A retrospective study of records of a regional eye bank was done to evaluate the results of screening and confirmatory tests for hepatitis B virus. The positive predictive value of the HBsAg screening test (using hepatitis B virus antibody neutralization for comparison) was low, 12.5%. False-positive donors accounted for 11.4% of the tissue used for penetrating keratoplasty during 1994. If confirmation tests were not allowed, considerable loss of suitable tissue would have occurred. We believe that the current standards allow safe and effective processing of donor ocular tissue.