巨细胞病毒特异性抗体IgG检测方法的建立

目的:建立一种以0.4U/ml为临界值的巨细胞病毒(CMV)特异性抗体IgG的检测方法。方法:用美国食品与药品监督局(FDA)认证的标准品标定临界值标准,以常规间接酶联免疫测定方法(ELISA)进行检测,对检测方法的各个环节进行比较研究,确定检测方法的最佳工艺流程;对179份育龄妇女血清进行检测,并经过FDA认证的ELISA方法为金标准与之进行比较。结果:灵敏度、特异性和准确性分别为100%(160/160)、94.7%(18/19)、99.4%(178/179);批内、批间变异系数分别为6.3%～10.5%,9.3%～14.8%,基本符合ELISA方法的标准(10%～15%)。结论:本研究建立的CMV—IgG检测方法灵敏度高、特异性好、重复性好,可用于育龄妇女CMV—IgG水平的检测。

Establishment of the Method of Detecting Cytomegalovirus Specific IgG Antibody

Objective:To establish a method of detecting cytomegalovirus (CMV) specific IgG antibody (0.4IU/ml as critical value).Methods:The critical criterion was demarcated by the standard approved by United States Food and Drug Supervisory Authority (FDA),and it was detected using conventional indirect enzyme-linked immunosorbent assay (ELISA).The best detecting process was confirmed by comparing ev- ery link of the assay.Serum detection was operated for 179 reproductive age women,which was compared with ELISA certified by the FDA.Results:The sensitivity,specificity and accuracy were 100% (160/ 160),94.7%(18/19),and 99.4% (178/179),respectively.The intra-assay and inter-assay coeffi- cients of variation were 6.3%,10.5%,9.3%,and 14.8%,respectively,roughly consistent with the standard (10%-15%) of the ELISA.Conclusion:The CMV-IgG antibody detecting method established in this study can be applied to testing CMV-IgG antibody level for reproductive age women,with its high sensitivity,strong specificity,and hypso-reproducibility.