四种基于重组梅毒螺旋体抗原的快速检测方法在梅毒诊断中的临床评估

Clinical evaluation of four recombinant Treponema pallidum antigen-based rapid tests in the diagnosis of syphilis.

作者信息

Wang Lin-na, Yang Lei, Zheng He-yi

机构信息

Department of Dermatology, Coal General Hospital, Beijing.

出版信息

Chin Med Sci J. 2007 Dec;22(4):250-3.

PMID:18246673

Abstract

OBJECTIVE

To assess the sensitivity, specificity, and feasibility of 4 recombinant Treponema pallidum antigen-based rapid tests in the diagnosis of syphilis.

METHODS

A total of 970 outpatients were selected from the Sexually Transmitted Diseases Centre of Peking Union Medical College Hospital. Venous blood was collected and serum was extracted. T. pallidum antibodies in whole blood, anticoagulant whole blood, and serum were detected using 4 recombinant T. pallidum antigen-based rapid tests. T. pallidum haemagglutination test (TPHA) was considered as the gold standard for the detection of T. pallidum specific antibodies in serum. The sensitivities and specificities of four methods were analyzed.

RESULTS

The sensitivities and specificities of Abbott Determine Syphilis TP test, SD-BIOLINE Syphilis 3.0 test, VISITECT-SYPHILIS test, and Syphicheck-WB test for serum specimens were 100% and 98.9%, 95.7% and 98.0%, 94.6% and 98.2%, 68.1% and 98.9%; for whole blood were 74.1% and 99.5%, 87.9% and 99.4%, 73.2% and 99.7%, 64.7% and 99.7%. The observed sensitivities of the 4 rapid diagnosis tests were not significantly different with TPHA (P > 0.05).

CONCLUSIONS

The 4 rapid tests show good performance and characteristics in the diagnosis of syphilis. Furthermore, they are more sensitive for serum specimens than whole blood.

摘要

目的

评估4种基于重组梅毒螺旋体抗原的快速检测方法在梅毒诊断中的敏感性、特异性和可行性。

方法

从北京协和医院性病中心选取970例门诊患者。采集静脉血并提取血清。使用4种基于重组梅毒螺旋体抗原的快速检测方法检测全血、抗凝全血和血清中的梅毒螺旋体抗体。梅毒螺旋体血凝试验（TPHA）被视为检测血清中梅毒螺旋体特异性抗体的金标准。分析4种方法的敏感性和特异性。

结果

雅培梅毒螺旋体抗体快速检测试剂、SD生物梅里埃梅毒螺旋体抗体快速检测试剂、维赛特梅毒螺旋体快速检测试剂和梅毒螺旋体抗体免疫印迹法检测血清标本的敏感性和特异性分别为100%和98.9%、95.7%和98.0%、94.6%和98.2%、68.1%和98.9%；检测全血的敏感性和特异性分别为74.1%和99.5%、87.9%和99.4%、73.2%和99.7%、64.7%和99.7%。4种快速诊断检测方法观察到的敏感性与TPHA无显著差异（P>0.05）。