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Elecsys® EBV panel

Immunoassays for the qualitative detection of specific antibodies to Epstein-Barr virus (EBV)
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Immunoassays for the qualitative detection of specific antibodies to Epstein-Barr virus (EBV)

The Elecsys® EBV panel consists of three immunoassays to detect antibodies specific to the Epstein-Barr virus (EBV). The three assays, Elecsys® EBV IgM, Elecsys® EBV VCA IgG, and Elecsys® EBV EBNA IgG should be used in combination to accurately determine the patient’s EBV infection stage.

 

Elecsys® EBV IgM

Elecsys® EBV VCA IgG

Elecsys® EBV EBNA IgG

 

Epstein-Barr virus (EBV)

 

Epstein-Barr virus (EBV) is the most ubiquitous virus in humans, infecting more than 90 % of the global population by adulthood.1,2 It is mainly transmitted by saliva, but also sexually, and via transplantation of solid organs and hematopoietic stem cells.2 After primary infection, EBV persists for life in a latent state in B-cells.1 Clinical symptoms vary according to the immune status of the patients. Primary infection is often asymptomatic during childhood, but often results in infectious mononucleosis (IM) in adolescents and adults. IM is characterized by the triad of fever, pharyngitis and lymphadenopathy, but is self limiting and rarely results in severe complications.3 In immunocompromised individuals, EBV infection has been associated with a variety of autoimmune and neoplastic disorders including lymphomas and carcinomas.3

EBV serology tests are routinely performed to determine the EBV infection stage, to confirm the clinical diagnosis of infectious mononucleosis, and to determine the immune status of transplant donors and recipients before transplantation.2,4,5 In immunocompetent individuals, the presence of VCA (viral capsid antigens) IgG and IgM EBV specific antibodies in the absence of EBNA-1 (Epstein-Barr nuclear antigens) IgG antibodies indicates acute infection. In contrast, the presence of VCA IgG and EBNA-1 IgG antibodies in the absence of IgM antibodies indicates past infection.4,6

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Elecsys® EBV IgM

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 402 / cobas e 801 analytical units

  • Testing Time

    18 minutes

  • Test principle

    μ-capture assay

  • Calibration

    2-point

  • Interpretation

    COI < 0.6 = non-reactive, COI ≥ 0.6 to < 1.0 = borderline, COI ≥ 1.0 = reactive

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel. Li-heparin, K2-EDTA, K3-EDTA plasma. Plasma tubes containing separating gel can be used.

  • Sample volume

    10 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    6 μL cobas e 402 / cobas e 801 analytical units

  • Onboard stability

    28 days cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    16 weeks cobas e 402 / cobas e 801 analytical units

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV 2.0 – 3.0 %
    cobas e 601 / cobas e 602 modules: CV 1.9 – 2.5 %
    cobas e 402 / cobas e 801 analytical units: CV 2.1 – 3.5 %

  • Relative sensitivity

    EBV early and acute infection (N = 414): 98.31 % (96.55 – 99.18 %)*

  • Relative specificity

    EBV seronegative and past infection (N = 1,174): 97.44 (96.38 – 98.20 %)*

* 95 % confidence interval (2-sided)

Elecsys® EBV VCA IgG

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 402 / cobas e 801 analytical units

  • Testing Time

    18 minutes

  • Test principle

    Double antigen sandwich assay

  • Calibration

    2-point

  • Interpretation

    COI < 0.7 = non-reactive, COI ≥ 0.7 to < 1.0 = borderline, COI ≥ 1.0 = reactive

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel. Li-heparin, K2-EDTA, K3-EDTA plasma. Plasma tubes containing separating gel can be used.

  • Sample volume

    35 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    21 μL cobas e 402 / cobas e 801 analytical units

  • Onboard stability

    28 days cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    16 weeks cobas e 402 / cobas e 801 analytical units

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV 2.4 – 3.8 %
    cobas e 601 / cobas e 602 modules: CV 2.6 – 6.6 %
    cobas e 402 / cobas e 801 analytical units: CV 2.6 – 4.2 %

  • Relative sensitivity

    Early, acute, and past EBV infection (N = 1,253): 98.40 % (97.55 – 98.96)*

  • Relative specificity

    EBV seronegative (N = 318): 98.74 % (96.81 – 99.51)*

* 95 % confidence interval (2-sided)

Elecsys® EBV EBNA IgG

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 402 / cobas e 801 analytical units

  • Testing Time

    18 minutes

  • Test principle

    Double antigen sandwich assay

  • Calibration

    2-point

  • Interpretation

    COI < 1.0 = non-reactive, COI ≥ 1.0 = reactive

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel. Li-heparin, K2-EDTA, K3-EDTA plasma. Plasma tubes containing separating gel can be used.

  • Sample volume

    10 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    6 μL cobas e 402 / cobas e 801 analytical units

  • Onboard stability

    28 days cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    16 weeks cobas e 402 / cobas e 801 analytical units

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV 2.8 – 3.6 %
    cobas e 601 / cobas e 602 modules: CV 2.3 – 2.6 %
    cobas e 402 / cobas e 801 analytical units: CV 2.4 – 2.9 %

  • Relative sensitivity

    Past EBV infection (N = 856): 99.53 % (98.80 – 99.82 %)*

  • Relative specificity

    EBV seronegative, early and acute infection (N = 751): 99.07 % (98.09 – 99.55 %)*

* 95 % confidence interval (2-sided)

Test tubes

Serological profile of the routine markers IgM, VCA IgG and EBNA IgG, to determine EBV infection, and interpretation of test results.1,6,7

Serology profile of EBV infection
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Assay result Corresponds to EBV infection stage
Elecsys® EBVIgM  Elecsys® EBV VCA IgG Elecsys® EBV EBNA IgG  
non-reactive non-reactive or borderline non-reactive Seronegative
reactive or borderline non-reactive non-reactive Presumed early phase of EBV infection*
reactive or borderline reactive or borderline non-reactive Acute phase of EBV infection
reactive reactive or boderline reactive Presumed transient phase of EBV infection*
non-reactive or borderline reactive or borderline reactive Past EBV infection
non-reactive reactive non-reactive Isolated VCA IgG*
non-reactive non-reactive reactive Isolated EBNA IgG*
* Indeterminate EBV infection stage. Additional and/or follow up testing recommended4,7

Abbreviations

 

EBNA: Epstein-Barr virus nuclear antigen.

VCA: Viral capsid antigen.

 

References

 

  1. Smatti, M.K., Al-Sadeq, D.W. et al. (2018) Epstein- Barr virus epidemiology, serology and genetic variability of LMP-1 oncogene among healthy population: an update. Front Oncol. 8, 211.
  2. Dunmire, S.K., Verghese, P.S., Balfour, H.H. (2018). Primary Epstein-Barr virus infection. J Clin Virol. 102, 84-92.
  3. Okano, M., Gross, T.G. (2012). Acute or chronic life-threatening diseases associated with Epstein- Barr virus infection. Am J Med Sci. 343(6), 483-9.
  4. De Paschale, M. and Cleirici, P. (2012). Serological diagnosis of Epstein-Barr virus infection: Problems and solutions. World J Virol. 1(1), 31-43.
  5. Nowalk, A., Green, M. (2016). Epstein-Barr Virus. Microbiol Spectr. 4(3).
  6. Hess, R. (2004). Routine Epstein-Barr virus diagnostics from the laboratory perspective: still challenging after 35 years. J Clin Microbiol. 42(8), 3381-7.
  7. Middeldrop, J.A. Epstein-Barr virus-specific humoral immune responses in health and disease. In: Münz, Ch, editor.Epstein Barr Virus.Volume 2. Springer, 2015. p 289-322.