Comparison of Technics for Determination of Epstein-Barr Virus Serological Diagnosis

Completed

• Conditions: EBV

• Registration Number: NCT03650231
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

This study compared the performance of three automated immunoassays, Architect (Abbott), Immulite (Siemens) and Liaison (Diasorin), for Epstein-Barr virus (EBV) serology. Ninety-one serum samples collected in Amiens University Hospital were analyzed for the presence of Viral Capsid Antigen (VCA) IgG and IgM and Epstein-Barr Nuclear Antigen (EBNA) IgG. The agreement between the three assays was calculated for each marker individually and for determination of the EBV profile, based on interpretation of the combination of these three EBV markers.

Detailed Description

This retrospective study was conducted on 91 samples collected between 2014 and 2015 for which EBV diagnosis was requested. The serological diagnosis of EBV infection was performed in the Amiens University Hospital virology laboratory (France). The median age of patients was 34 years (mean: 38 years, range: 3-82 year) with a sex ratio of 50%. Sixteen of the 91 samples concerned children (\<15 years).

This study compared the performance of three automated immunoassays, Architect (Abbott), Immulite (Siemens) and Liaison (Diasorin), for Epstein-Barr virus (EBV) serology. Ninety-one serum samples collected in Amiens University Hospital were analyzed for the presence of Viral Capsid Antigen (VCA) IgG and IgM and Epstein-Barr Nuclear Antigen (EBNA) IgG. The agreement between the three assays was calculated for each marker individually and for determination of the EBV profile, based on interpretation of the combination of these three EBV markers.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-10-29
• Study Completion: 2017-10-29
• Status Verified: 2018-08
• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-27
• Last Update Submitted: 2018-08-27
• Study First Posted: 2018-08-28
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Patients with EBV diagnosis
• Age between 3 and 82 years

Exclusion Criteria

• Patient <3 years
• Patient > 82 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Capacity of the three assays to detect VCA IgM	2years	The aim of the present study is to evlaute the capacity of the three tests to detect VCA IgM. 91 samples was collected and tested for EBV VCA IgG, EBV VCA IgM and EBV EBNA IgG in order to determine infection status (primary EBV infection, past infection, absence of infection and indeterminate status).