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首页> 外文期刊>Journal of Clinical Microbiology >Development of a Real-Time PCR Assay To Detect Treponema pallidum in Clinical Specimens and Assessment of the Assay's Performance by Comparison with Serological Testing
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Development of a Real-Time PCR Assay To Detect Treponema pallidum in Clinical Specimens and Assessment of the Assay's Performance by Comparison with Serological Testing

机译：实时PCR检测法在临床标本中检测梅毒螺旋体并通过与血清学检测比较评估其性能的方法的开发

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The incidence of infectious syphilis in men who have sex with men and human immunodeficiency virus-infected patients has increased steadily in Victoria, Australia, since 2002. A TaqMan real-time PCR assay targeting the polA gene of Treponema pallidum (TpPCR) was developed. The analytical sensitivity of the assay was estimated to be 1.75 target copies per reaction. Initially, the assay was used to test a variety of specimens (excluding blood) from 598 patients. Of the 660 tests performed, positive PCR results were obtained for 55 patients. TpPCR results were compared with serology results for 301 patients being investigated for early syphilis. Of these patients, 41 were positive by both TpPCR and serology, 246 were negative by both TpPCR and serology, 4 were TpPCR positive but negative by serology, and 10 were TpPCR negative but showed evidence of recent or active infection by serology. Directly compared with serology, TpPCR showed 95% agreement, with a sensitivity of 80.39% and a specificity of 98.40%. Potential factors leading to the discrepant results are discussed. Concurrent serology on 21 patients with TpPCR-positive primary syphilitic lesions demonstrated that a panel of current syphilis serological tests has high sensitivity for the detection of early syphilis. We found that TpPCR is a useful addition to serology for the diagnosis of infectious syphilis. Direct comparison with other T. pallidum PCR assays will be required to fully assess the limitations of the assay.
机译：自2002年以来，在澳大利亚维多利亚州，与男性发生性关系的男性和感染人类免疫缺陷病毒的男性患者的传染性梅毒发病率稳步上升。针对 polA 基因<开发了苍白梅毒螺旋体（TpPCR）。该测定的分析灵敏度估计为每个反应1.75个目标拷贝。最初，该测定法用于测试598例患者的各种标本（不包括血液）。在进行的660次测试中，有55位患者获得了阳性PCR结果。将301名接受早期梅毒调查的患者的TpPCR结果与血清学结果进行比较。在这些患者中，TpPCR和血清学均阳性41例，TpPCR和血清学均阴性246例，TpPCR阳性但血清学均为阴性，10例TpPCR阴性，但显示出近期或主动感染的证据。与血清学直接比较，TpPCR显示出95％的一致性，灵敏度为80.39％，特异性为98.40％。讨论了导致结果不一致的潜在因素。对21名TpPCR阳性原发性梅毒病变患者进行并发血清学检查，结果表明，一组当前的梅毒血清学检测对早期梅毒的检测具有很高的敏感性。我们发现，TpPCR是血清学诊断感染性梅毒的有用补充。与其他 T的直接比较。需要使用pallidum PCR测定法来全面评估测定法的局限性。

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