NCT06457438

Molecular Characteristics and Prevalence of Viral Hepatitis E in Human Tissue and Cell Donors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In this study, the researchers want to focus on the prevalence of anti-HEV antibodies by a new generation test, direct detection of HEV RNA, and its genotypic analysis in a group of human tissue and cell donors.

Detailed description

At the Department of Laboratory Medicine of the Faculty of Medicine of the Faculty of Medicine of the National University of Health Sciences, human tissue and cells from donors will be examined for the assessment of health eligibility and donor selection according to Decree No. 422/2008 Coll. According to the current legislation, the determination of IgG and IgM antibodies against HEV or the HEV RNA method is not part of the standard examination of human tissue and cell donors for the assessment of their health eligibility.

Conditions

• Hepatitis E

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Elecsys Anti-HEV IgG, IgM	Diagnostic test used to determine antibodies in blood and serum.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-06-13
• Last updated: 2024-06-13

Locations

1 site across 1 country: Czechia