TORCH-IgM捕获法ELISA试剂盒的研制和应用

目的 为了发展TORCH近期感染的IgM酶免疫诊断技术。方法 以抗人IgM McAb包板，加待检血清、TORCH抗原，接着加酶标记的抗TORCH—McAb，最后加3，3’，5，5’-四甲基联苯胺(TNB)显色。用这种自制的捕获法ELISA(C—ELISA)试剂盒和HOPE公司的间接法ELISA(I—ELISA)试剂盒平行检测1196份孕妇血清TORCH-IgM。结果C—ELISA试剂盒检出阳性血清67份，并经其他试验证实为阳性。其中4份用I—ELISA试剂盒检测为阴性。由乳胶凝集试验诊断为类风湿因子(RF)阳性的2份血清，经I—ELISA试剂盒检测为阳性，但经C—ELISA试剂盒检测为阴性。结论 在检测孕妇TORCH—IgM方面，C—ELISA比I-ELISA有更强的敏感性和更高的特异性。C—ELISA试剂盒是诊断TORCH近期感染的良好工具。

Preparation and application of a capture ELISA kit for TORCH-IgM

Objective To develop an IgM enzyme immunoassay for diagnosis of recent TORCH infection. Methods In the first step,sera was added to the wells of microtiter plates coated with anti-human IgM McAb. TORCH antigen and peroxidase labeled mouse anti-TORCH McAb were then incubated. 3,3',5,5'-tetramethylbenzidine (TMB) was used as a substrate and the color reaction was read. The home made capture ELISA (C-ELISA) and the HOPE company indirect ELISA (I-ELISA) were used to measure IgM antibody to TORCH in a total of 1 196 serum specimens from pregnant women. Results Sixty-seven IgM-positive serum samples were diagnosed by the C-ELISA and confirmed by other tests. Four of Sixty-seven serum samples were negative on the I-ELISA. Two RF positive sera,that were positive on the I-ELISA but negative on the C-ELISA, were diagnosed by the latex agglutination test. Conclusion C-ELISA has higher sensitivity and specificity than I-ELISA in measurement IgM antibody to TORCH from pregnant women. C-ELISA kit is the tool for diagnosis of recent TORCH infection.