Abstract
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+1.0093 x, 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.
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