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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 3 to 82 years
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

EBV

Being tested

Serological giagnosis

Keywords

Epstein-barr virus, infectious mononucleosis

Medical subject headings

Epstein-Barr Virus Infections, Infectious Mononucleosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Serological giagnosisOther

  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 being measured

The primary outcome is the main question the study is designed to answer.

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).

   Measured: 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Aug 2018
2. Study start1 Jan 2015
3. Primary completion29 Oct 2017
4. Study completion29 Oct 2017

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for EBVStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.