CENBIMO S.L

INTRODUCTION

The Epstein-Barr virus is a member of the gamma-herpes viruses (HHV-4). It is a linear 184,000 base pairs double stranded DNA virus.

It was the first virus to be discovered as oncogenic (1).

Primoinfection by this virus can show signs of a slight viral infection or it can present as Infectious Mononucleosis.

The most common target cells for the Epstein-Barr virus are the B lymphocyte and nasopharyngeal epithelial cell.

The Epstein-Barr virus massively infects the human population and sero-epidemiological studies show that 90% of adults have been infected by this virus (2).

Latently infected B lymphocytes express abundantly (104 -105 copies), among other genes, a short nonpolyadenylated chain of RNA that does not transduce to a protein, consisting of two fragments know as EBER 1 and EBER 2. The expression of EBER (Epstein-Barr virus encoded RNAs) is nuclear.

Although the function of EBER is unknown, it is believed that it may play a role in virus-produced oncogenesis (3).

There are numerous human tumors associated with EBV, ranging from non-differentiated nasopharyngeal carcinoma to African Burkitt's lymphoma, Hodgkin's disease Mixed cellularity, some B, T and NK lymphomas, as well as in

lymphoproliferative processes associated with immunodeficiency(4).

INTENDED USE

For use in In Vitro Diagnosis.

Histosonda EBER is intended for the detection of EBER 1+2 RNA in cells infected by theEpstein-Barr virus, both in reactive and tumoral cells.

Its use is intended for the aforementioned tumors, as well as in lymph nodes of patients with atypical reactive pathology as produced by Infectious Mononucleosis. This detection is carried out by in situ hybridization in paraffin-embedded, formalin-fixed histological sections.

WARNINGS AND PRECAUTIONS

Histosonda EBER has been designed for professional use in In Vitro Diagnosis and must be manipulated by qualified and accordingly trained personnel.

In order to obtain the best results, the instructions contained in the manual must be followed. Any change to the indicated temperatures, times or any other step of the process can lead to poor results.

KIT COMPONENTS

The kit includes 20 single test tubes of lyophilized Histosonda EBER consists of a fragment of single stranded DNA of 526 nucleotides, complementary to expressed EBER. This probe detects the EBER gene in full, including EBER 1 and EBER 2. The DNA of the probecontains nucleotides that have been labeled with Digoxigenin.