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Infectious Serology · Epstein-Barr EBNA-1 CLIA
TestLine Distributed by Goffin Diagnostics

CLIA EBV EBNA-1 IgG

Chemiluminescence kit for the detection of IgG antibodies to Epstein–Barr virus nuclear antigen 1 in human serum or plasma

CLIA CE-IVD TestLine 1 Package (100 Tests)
Technique
CLIA
Brand
TestLine
Packaging
1 Package (100 Tests)
Diagnostic Panel
Herpes Viruses
Download documentation
Runs on KleeYa® Automated CLIA Analyser See the analyser and everything it runs

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Product details

This kit in detail

  • Detection of IgG antibodies to the EBNA-1 antigen of Epstein Barr Virus (EBV)
  • Aid to diagnose infectious mononucleosis
  • Aid to differentiate various stages of infection
  • Intended for human serum and plasma
  • Recombinant antigens with highly specific immunodominant epitopes of EBV EBNA-1 used

Description

Epstein-Barr virus (EBV) is a member of the Herpetoviridae family (HHV4). It spreads mainly through air-borne transmission or direct contact; the incubation period is 1-2 month. EBV is the etiologic agent of infectious mononucleosis (IM) and it is also related to Burkitt’s lymphoma and nasopharyngeal carcinoma. Infection with EBV usually occurs early in life. Some people develop typical symptoms of IM, like fever, pharyngitis, and lymphadenopathy. EBV persists latently in the organism for the rest of the individual’s life and can be reactivated.

Determination of specific IgA, IgG, and IgM antibodies against EBV antigens (VCA, EBNA-1, EA-D) is a powerful tool for the diagnosis and determination of stage of EBV infection.

Anti-VCA IgG antibodies are anamnestic and persist in infected individuals for their entire life; its rise indicates reinfection or reactivation. IgM and IgA antibody responses are typical for active infection.

Anti-EBNA-1 IgM antibodies are detected during the acute phase of primary infection, while IgG antibody response is delayed. Absence of IgG anti-EBNA with concomitant presence of IgG and IgM anti-VCA is a diagnostic marker of IM.

Anti-EA-D IgM and IgG antibodies to EA-D antigen are additional markers of primary EBV infection. High titres of IgG anti-EA-D are typically present in late acute and convalescent phases of IM.

Technical data

  • Assay time: 30 min
  • Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
  • Sample matrix: Serum, Plasma
  • Sample volume: 10 μL
  • Measuring range: 3-320 U/ml
  • Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
  • Note: The kits are CE-IVD certified and intended for professional use.

Specifications

  • Catalog Number: CL-EBG100
  • Size: 100 tests
  • Regulatory status: CE IVD
  • Clinical topic: Infectious Diseases
  • Diagnostic panel: Herpes Viruses
  • Producer: TestLine Clinical Diagnostics s.r.o.

References

  • 20652034,23514966,21191077,11725096,8385705,8860358,3010447,28661055,4341865
  • Reagent Cartridge with specific reagents for the assay
  • magnetic particles
  • calibrators
Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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