【摘要】 目的建立并评价人类巨细胞病毒PP65 Ig G抗体间接ELISA检测试剂。方法原核表达并纯化重组HCMV PP65332~561蛋白,包被酶标板,优化试剂检测条件,试制HCMV-Ig G间接ELISA试剂,分析试剂的精密度,并通过对100份样本的检测,与市售进口HCMV-Ig G间接ELISA试剂比较,分析了自制试剂的特异性、敏感性和符合率。结果试制的ELISA试剂批内和批间变异度均小于10%,与其他疱疹病毒感染血清均无交叉反应;与进口试剂的总符合率达到95%。结论该方法具有良好的特异性、敏感性,稳定性和可重复性,为HCMV病毒感染的流行病学调查提供了新的备选方法。更多还原

【Abstract】 This study was performed to establish and evaluate a ELISA kit for detecting PP65 specific antibody Ig G of human cytomegalovirus. After prokaryotic expression and purification of recombinant PP65322~561protein, the ELISA plate was coated, the test conditions were optimized and adopted, then the indirect ELISA kit for detection of HCMV-Ig G was established and the precision of the kit was assessed. The specificity, sensitivity and coincidence rate of the kit were analyzed through compared with an imported HCMV-Ig G indirect ELISA reagent in detecting 100 samples. The coefficients of variation within assay and between assays were all lower than 10%; no cross reaction was detected in other herpes virus infecting serum. The coincidence rate of the constructed kit to the imported reagents achieved 95%. In conclusion, the constructed method shows higher specificity, sensitivity,stability and repeatability, and it provides a new method for epidemiological survey of HCMV infection.更多还原