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

University Hospital Ostrava

Status: Enrolling

Conditions: Hepatitis E

Treatments: Diagnostic Test: Elecsys Anti-HEV IgG, IgM

Study type: Interventional

Funder types: Other

Identifiers

NCT06457438

05/OR-FNOs/2024 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients indicated for organ or cell donation

Exclusion criteria

• none

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Organ Donors

Experimental group

Description:

Samples obtained from organ donors will be included in this study arm.

Treatment:

Diagnostic Test: Elecsys Anti-HEV IgG, IgM

Cell Donors

Experimental group

Description:

Samples obtained from cell donors will be included in this study arm.

Treatment:

Diagnostic Test: Elecsys Anti-HEV IgG, IgM