Evaluation of a rapid and convenient method for determination of cytomegalovirus immunoglobulin M

We evaluated a method for determination of human cytomegalovirus (hCMV) immunoglobulin M (IgM) by CLIA, and analyzed its clinical value in patients with infectious mononucleosis. Serum samples from 407 participants were measured on an automatic CLIA analyzer. At the same time the serum samples were measured by enzyme-linked immunosorbent assay (ELISA). An assessment of technological quality (methodology) in diagnostic tests demonstrated that the sensitivity of CLIA was 1.0 AU/mL and the functional sensitivity was <1.6 AU/mL. The within- and between-assay imprecision values for different concentrations were all under 5%. Recoveries for both methods were 96-110%. The linear regression equation between expected values and measured values was y=0.644+0.986x, and correlation coefficient was 0.9991 (P<0.0001). The receiver operating characteristic (ROC) curve showed that both the sensitivity and specificity of CLIA surpassed 90%. The area under the curve (AUC) was 0.990, which was significantly higher than that of ELISA (P<0.05). The results indicate that CLIA is an excellent method for hCMV IgM measurement, and thus may be useful for clinical diagnoses.