Background: Infectious mononucleosis is the common clinical manifestation of primary Epstein-Barr virus (EBV) infection in young children. We evaluated a chemiluminescent immunoassay method for the determination of serum anti-viral capsid antigen IgM antibody and its clinical value in the diagnosis of infectious mononucleosis.
Methods: Concentrations of the antibody in serum samples from 187 children measured by chemiluminescent immunoassay were compared with those measured by ELISA.
Results: Assessment of technologic quality (methodology) in diagnostic tests demonstrated that sensitivity of CLIA was 0.64 U/ml and the functional sensitivity was <0.9 U/ml. The within-assay and the between-assay imprecisions of different concentrations were all <5%. Recoveries were all in 93-107%. The linear regression equation between expected values and measured values was y=0.0967+1.0093x, correlation coefficient was 0.9996 (p<0.0001). The ROC curve showed that the sensitivity and specificity of the CLIA both were >90%. The area under the curve was 0.992, which was significantly higher than that of ELISA (p<0.05).
Conclusion: The CLIA was the excellent method for EBV-VCA IgM measurement at present and can improve the clinical diagnosis of infectious mononucleosis.