Zhang Jiajun, Li Junchuan, Zhang Youshan, Zhu Hongyu, Ma Qing, Hang Gang
First Affiliated Hospital of Yangtze University, Jingzhou HuBei, China.
J Clin Lab Anal. 2007;21(5):255-9. doi: 10.1002/jcla.20153.
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.
我们评估了一种通过化学发光免疫分析（CLIA）测定人巨细胞病毒（hCMV）免疫球蛋白M（IgM）的方法，并分析了其在传染性单核细胞增多症患者中的临床价值。在自动CLIA分析仪上检测了407名参与者的血清样本。同时，采用酶联免疫吸附测定（ELISA）法检测血清样本。对诊断试验的技术质量（方法学）评估表明，CLIA的灵敏度为1.0 AU/mL，功能灵敏度<1.6 AU/mL。不同浓度的批内和批间不精密度值均在5%以下。两种方法的回收率均为96% - 110%。预期值与测量值之间的线性回归方程为y = 0.644 + 0.986x，相关系数为0.9991（P<0.0001）。受试者工作特征（ROC）曲线显示，CLIA的灵敏度和特异性均超过90%。曲线下面积（AUC）为0.990，显著高于ELISA（P<0.05）。结果表明，CLIA是一种检测hCMV IgM的优秀方法，可能对临床诊断有帮助。
