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Testing for hepatitis B surface antigen in processing donor tissue for penetrating keratoplasty
M R Migden1, W H Dennis, T E Clinch
1Utah Lions Eye Bank, John A. Moran Eye Center, University of Utah Health Sciences Center, USA.
Purpose:
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.
Methods:
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.
Results:
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.
Conclusions:
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.