中文摘要：

目的研究人乳头瘤病毒（HPV）11型E7蛋白在原核细胞的表达及其在尖锐湿疣（CA）血清学诊断中的应用价值。方法用PCR从CA患者组织中扩增HPV11E7全长基因，构建重组质粒pET32a（＋）／HPV11 E7，经异丙基硫代-β-D-半乳糖苷（IPTG）诱导后表达，用十二烷基磺酸钠-聚丙烯酰胺凝胶电泳和蛋白质印迹法（WB）分析鉴定；经镍螫合亲和层析胶体（Ni—NTA Agarose）纯化HPV11 E7融合蛋白后作抗原，用间接ELISA法对93例CA患者、43例宫颈癌患者和58名健康对照者血清标本进行IgG抗体检测。结果HPV11 E7融合蛋白在原核表达系统中呈较高效表达（浓度为40μg／na）。CA组、宫颈癌组和健康对照组血清IgG抗体均值分别为1．545±0．131、0．586±0．155和0．674±0．150，阳性率分别为76．3％（71／93）、11．6％（5／43）和5．2％（3／58）；CA组血清IgG抗体均值及阳性率均高于宫颈癌组和对照组（均P〈0．01）。结论HPV11 E7融合蛋白具较强的抗原性，用于CA血清学诊断试剂的研制具有临床应用价值。

英文摘要：

Objective To investigate expression of Human papillomavirus （HPV） 11 type E7 protein antigen in prokaryotic cells and its potential use for the serodiagnosis of condyloma acuminatum （CA）. Methods The full-length gene encoding for HPV11 E7 protein was amplified by PCR, and cloned into vector pET32a（ ± ） to form recombinant pET32a（ ± ）/HPV11 E7 plasmid. The fusion His-E7 protein was expressed and analyzed by using SDS-PAGE and Western blotting. Using ELISA assay, HPV11 E7 fusion protein were also used to screen human serum IgG antibody from 93 patients with CA,43 patients with cervix cancer and 58 healthy control subjects. Results Highly expressed fusion His-E7 protein was obtained, and purified protein served as a special diagnostic antigen to screen human serum antibody for CA serodiagnosis. It showed that CA group,cervix cancer group and healthy control human serum IgG antibody average value were 1. 545 ± 0. 131,0. 586 ± 0. 155 and 0. 674 ± 0. 150 respectively, positive rate were 76. 3% （71/93）, 11.6% （5/43） and 5.2% （ 3/58 ）. There was significantly difference between the CA group to compare cervix cancer group and healthy control （P 〈 0. 01 ）. Conclusion It is likely that HPV11 E7 fusion protein could be used as a potential antigen for CA serodiagnosis.