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

NCT03650231 | Completed

• 1 other identifier: PI2017_843_0042
• Study Type: observational
• Target: 91
• Locations: 0 countries
• Sites: N/A

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.

Conditions

EBV

Keywords

Epstein-barr virus; infectious mononucleosis

Outcome Measures

Primary Outcomes (1)

• Capacity of the three assays to detect VCA IgM

  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).

  2years

Interventions

Serological giagnosis OTHER

The serological diagnosis of EBV infection was performed in the Amiens University Hospital virology laboratory (France). 91 routinely collected samples were analyzed by Immulite, Architect, and Liaison Blood samples were centrifuged for 15 min at 2500g at room temperature. Sera were aliquoted and first analyzed by Immulite. All samples were 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).

Eligibility Criteria

• Age: 3 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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)

You may qualify if:

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

You may not qualify if:

• Patient \<3 years
• Patient \> 82 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Infectious Mononucleosis

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sandrine Castelain, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 28, 2018
• Study Start: January 1, 2015
• Primary Completion: October 29, 2017
• Study Completion: October 29, 2017
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share