Optimizing Corneal Transplant Safety: The Impact of Mandatory Prion Protein Testing on Iatrogenic Creutzfeldt-Jakob Disease Prevention in the Czech Republic.

Abstract

The purpose of this study was to assess the effectiveness of legally mandated testing for pathogenic prion proteins in corneal tissue donors in the Czech Republic, considering its impact on safety, financial, and temporal costs. Between January 2007 and December 2023, standardized brain regions were collected from all corneal tissue donors in the Czech Republic. Tissue samples were tested for the presence of pathogenic prion proteins by the Czech Reference Laboratory for Human Prion Diseases. The testing used a Western blot analysis, using 2 distinct monoclonal anti-PrP antibodies. A total of 8030 donors were tested. Four tested samples were initially weakly positive. Subsequent testing conclusively determined these samples to be negative. The remaining 8026 tests yielded negative results confirming the safety of donor screening. We did not observe any cases of proven transmissible spongiform encephalopathies (TSEs). TSE testing has consistently confirmed that no patients with TSE have been selected into the corneal donor pool, solidifying the effectiveness of the active surveillance program and exclusion criteria. We propose that these mechanisms effectively prevent patients with TSEs from being included in the corneal tissue donor pool. However, the substantial financial costs and a 2-day delay in processing pose challenges, contributing to graft nonutilization and potential negative impacts on patients in acute need. Moreover, the unique requirement for pathogenic prion testing in the Czech Republic also makes importing any corneal grafts from other countries impossible, as those tissues do not fulfill Czech legal requirements.