EBV VCA IgM ELISA Kit (Epstein–Barr Virus Viral-Capsid Antigen)

Full Name: EBV VCA IgM ELISA Kit (Epstein–Barr Virus Viral-Capsid Antigen)
Reactivity: Human
Sample Type: Serum, Plasma
Sensitivity: 0.86 U/ml

BACKGROUND

Epstein–Barr virus viral-capsid antigen (EBV-VCA) is a target for the anti-VCA antibodies and is important for the viral capsid of the Epstein–Barr virus (EBV). Anti-VCA antibodies have played a vital role in the diagnosis of infectious mononucleosis. An abnormal result is an indication of either a current or a past EBV infection.

The three antibodies which are useful in the test include viral capsid antigen (VCA) IgG, VCA IgM and the Epstein-Barr nuclear antigen (EBNA). The presence of VCA-IgG antibodies can indicate that an EBV infection has occurred recently or in the past. Whereas the presence of VCA-IgM antibodies along with the absence of EBNA indicate a recent occurrence of the infection.

The detection of antibodies to EBNA indicate an infection which occurred in the past (since EBNA develop 6-8 weeks after the time of infection). In cases with primary infections, the sensitivity of anti-VCA IgM and anti-VCA IgG have been estimated to be 100% reliable.

INTENDED USE

Human EBV VCA IgM ELISA kit is intended for analysing in-vitro amounts of human IgM antibodies to Epstein–Barr virus viral-capsid antigen (EBV VCA IgM) using samples of plasma or serum. This assay has a minimum analytical sensitivity limit of 0.86 U/ml.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

Calibrator A (Negative Control).
Calibrator B (Cut-Off Standard).
Calibrator C (Weak Positive Control).
Calibrator D (Positive Control).
Sample Diluent.
Enzyme Conjugate.
TMB Substrate.
Stop Solution.
Washing Buffer (10x).
EBV VCA coated microtiter strips.

SENSITIVITY

The minimum detection sensitivity level of human IgM directed against Epstein–Barr virus viral-capsid antigen (EBV VCA-IgM) using current EBV VCA IgM ELISA kit was 0.86 U/ml. The dynamic range for this assay is 1.0 – 150.0 U/ml.

ASSAY CHARACTERISTICS

– Intra-Assay-Precision: 7.0 %
– Inter-Assay-Precision: 6.3 – 12.1 %
– Inter-Lot-Precision: 2.7 – 10.8 %
– Analytical Sensitivity: 0.86 U/mL
– Recovery: 113 – 119 %
– Linearity: 78 – 118 %
– Cross-Reactivity: No cross-reactivity to Mumps, Varicella and Measles.
– Interferences: No interferences to bilirubin up to 0.3 mg/mL, hemoglobin up to 8.0 mg/mL and triglycerides up to 5.0 mg/mL.
– Clinical Specificity: 100 %
– Clinical Sensitivity: 98 %

REFERENCES

Prevalence of primary versus reactivated Epstein-Barr virus infection in patients with VCA IgG-, VCA IgM- and EBNA-1-antibodies and suspected infectious mononucleosis. J Clin Virol. (2007) 38 (4): 292-7. Nystad T.W. and Myrmel H.
Epstein-Barr virus serology in bone marrow transplantations: a one-year retrospective study with detection of EBV IgM-VCA-specific antibodies. J Med Virol. (1986) 18 (4): 349-60. Morinet F., et al.
Evaluation of Epstein-Barr virus antibodies, anti-VCA avidity by immunofluorescence and immunoblot assays for assessment of Epstein-Barr virus immunologic state. J Virol Methods. (2009) 159 (2): 300-2. Sener A.G., et al.
Evaluation of four commercial systems for the diagnosis of Epstein-Barr virus primary infections. Clin Vaccine Immunol. (2011) 18 (3): 444-8. de Ory F., et al.

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