Feng Zhenru, Li Zhiyan, Sui Baohuan, Xu Guobing, Xia Tiean
Department of Clinical Laboratory, Peking University First Hospital, Beijing 100034, China.
Clin Chim Acta. 2005 Apr;354(1-2):77-82. doi: 10.1016/j.cccn.2004.11.010. Epub 2004 Dec 30.
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.
Concentrations of the antibody in serum samples from 187 children measured by chemiluminescent immunoassay were compared with those measured by ELISA.
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).
The CLIA was the excellent method for EBV-VCA IgM measurement at present and can improve the clinical diagnosis of infectious mononucleosis.
传染性单核细胞增多症是幼儿原发性EB病毒（EBV）感染的常见临床表现。我们评估了一种化学发光免疫分析法用于测定血清抗病毒衣壳抗原IgM抗体及其在传染性单核细胞增多症诊断中的临床价值。
采用化学发光免疫分析法对187例儿童血清样本中的抗体浓度进行测定，并与酶联免疫吸附测定法（ELISA）的测定结果进行比较。
诊断试验的技术质量（方法学）评估表明，化学发光免疫分析法（CLIA）的灵敏度为0.64 U/ml，功能灵敏度<0.9 U/ml。不同浓度的批内和批间不精密度均<5%。回收率均在93%-107%之间。预期值与测量值之间的线性回归方程为y=0.0967+1.0093x，相关系数为0.9996（p<0.0001）。ROC曲线显示，CLIA的灵敏度和特异性均>90%。曲线下面积为0.992，显著高于ELISA（p<0.05）。
CLIA是目前检测EBV-VCA IgM的优良方法，可提高传染性单核细胞增多症的临床诊断水平。
