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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Abbott Architect®, Siemens Immulite®, and Diasorin Liaison® for Determination of Epstein-Barr Virus Serological Diagnosis

Conditions
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EBV

Intervention / Treatment
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* Other: Serological giagnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with EBV diagnosis Age between 3 and 82 years Exclusion Criteria: Patient <3 years Patient > 82 years

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Serological giagnosis|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epstein-barr virus, infectious mononucleosis