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机构地区:[1]广东省东莞市妇幼保健院产前诊断中心,广东东莞523125
出 处:《中国医药导报》2012年第15期116-118,共3页China Medical Herald
摘 要:目的建立免疫PCR方法检测梅毒螺旋体抗原和梅毒螺旋体抗体两种方法学,并比较两种方法学的敏感性、特异性和重复性。方法选择2011年我院梅毒血清学ELISA法检测者1520例并梅毒分期;建立免疫PCR法检测梅毒螺旋体抗原和梅毒螺旋体抗体两种方法,然后对梅毒螺旋体血清学阳性标本10倍系列稀释,比较免疫PCR法敏感性;同时采用正常健康血清标本观察免疫PCR法特异性;最后采集梅毒阳性血液分装成两份标本,监测两种免疫PCR法试验批内和日间重复性。结果 1 520例患者中,梅毒患者136例。梅毒患者中女性占77.2%(105/136),孕妇占19.1%(26/136)。梅毒分期以一期梅毒感染为主,与其他期比较具有统计学意义(P<0.05)。IPCR-Ag法检测梅毒螺旋体抗原敏感性是ELISA法的104倍,TPPA和TRUST法的106。IPCR-Ab法检测梅毒螺旋体抗体敏感性是ELISA法的103倍,TPPA和TRUST法的105。两种免疫PCR法测检查正常健康人群梅毒螺旋体结果均为阴性。IPCR-Ab法试验批内CV为11.61%,日间CV为18.12%;IPCR-Ag法试验批内CV为18.61%,日间CV为22.24%,两者相比具有统计学意义(P<0.05)。结论免疫PCR法检测梅毒螺旋体具有高度的敏感性和特异性,但重复性较差。Objective To establish and study the technology to detect Treponema pallidum specific antigen and antiboby by immuno-PCR, and eompare with sensibility, specifieity and reproducibility. Methods 1 520 eases with syphilis were provided by ELISA and by stages. The technology of detecting Treponema pallidum specific antigen and antiboby by ina- muno-PCR was established, and sensibility by 10 double time liquor natrii chloridi isotonicus was compared, and speci- ficity by normal specimen was observed, the reproducibility was studied by batch and days. Results The rate was 8.9% on 136 positive syphilis cases detected in 1 520, and 77.2% in femme, and 19.1% in pregnant woman. The primary syphilis possess major cases. The sensitivity of immuno-PCR diagnostic antigen method was 104 times higher than that of routine ELISA method, and 106 times higher than TPPA and TRUST. The sensitivity of immuno-PCR diagnostic antiboby method was 103 times higher than that of routine ELISA method, and 105 times higher than TPPA and TRUST. The specificity was all by immuno-PCR in normal specimen. The bath coefficient of differentiation was 11.61% by immuno-PCR diagnostic antigen, and 18.61% by immuno-PCR diagnostic antiboby. The days coefficient of differentiation was 18.12% by immuno- PCR diagnostic antigen, and 22.24% by immuno-PCR diagnostic antiboby. Conclusion It indicates that immuno-PCR method possesses fairly high sensitivity and specificity and has much discrepancy of reproducibility.
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