Related Experiment Videos
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.
American Journal of Ophthalmology
|September 1, 1996
Summary
Confirmatory testing for hepatitis B virus surface antigen (HBsAg) is crucial for eye banks. Eliminating these tests would lead to significant loss of viable cornea tissue for transplantation.
Area of Science:
- Ophthalmology
- Virology
- Public Health Policy
Background:
- The Food and Drug Administration (FDA) proposed altering hepatitis B virus (HBV) screening protocols for eye bank cornea donors.
- Current protocols involve confirmatory testing to minimize false-positive hepatitis B virus surface antigen (HBsAg) results.
- The FDA considered a policy change that would eliminate confirmatory testing.
Purpose of the Study:
- To evaluate the impact of eliminating confirmatory HBV testing on the usability of cornea tissue.
- To assess the positive predictive value of HBsAg screening tests in eye bank donors.
Main Methods:
- A retrospective analysis of records from a regional eye bank was conducted.
- Screening and confirmatory test results for HBV were examined.
Main Results:
- The HBsAg screening test demonstrated a low positive predictive value of 12.5% when compared to HBV antibody neutralization.
- False-positive results from HBsAg screening led to an 11.4% loss of potential cornea tissue for penetrating keratoplasty in 1994.
Conclusions:
- Discontinuing confirmatory testing would result in a substantial loss of suitable donor cornea tissue.
- Current standards for processing donor ocular tissue, including confirmatory testing, ensure both safety and efficacy.