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一种免疫过滤装置,用于同时检测梅毒患者的非梅毒螺旋体和梅毒螺旋体抗体。

An immunofiltration device for the simultaneous detection of non-treponemal and treponemal antibodies in patients with syphilis.

机构信息

Centers for Disease Control and Prevention, Division of STD Prevention, Atlanta, Georgia 30333, USA.

出版信息

Sex Transm Infect. 2010 Dec;86(7):532-6. doi: 10.1136/sti.2010.042937. Epub 2010 Jul 23.

DOI:10.1136/sti.2010.042937
PMID:20656720
Abstract

OBJECTIVE

The development of a rapid immunofiltration (flow-through) test for the simultaneous detection of non-treponemal and treponemal antibodies in the serum of patients with syphilis.

METHODS

The assay is rapid, inexpensive, and requires limited expertise in interpreting the results. The test is based on the principle of immunofiltration, with two antigens and control material spotted on the membrane of a through-flow device. A positive test is characterised by the appearance of three red/magenta spots within 2-10 min.

RESULTS

A total of 376 banked serum samples obtained from the Georgia Public Health Laboratory was examined by the flow-through test, the rapid plasma reagin (RPR) test and the Treponema pallidum passive particle agglutination assay (TPPA). The sensitivity and specificity of the non-treponemal spot were 96.5% and 97.7%, respectively, when compared with the RPR test, and the sensitivity and specificity of the treponemal test spot were 97.3% and 99.1% when compared with the TPPA test. In addition, the test yielded equivalent results to those obtained in comparator tests when 104 sera from cases of syphilis of known stage, 49 sera from diseases other than syphilis and 23 sera known to exhibit biological false-positive reactions were tested in parallel.

CONCLUSIONS

These results indicate that the dual treponemal and non-treponemal assay could be used as a screen and confirmatory test for the serological diagnosis of syphilis in remote or resource-poor settings where there is a need to provide counselling and treatment at the initial consultation.

摘要

目的

开发一种快速免疫滤过(流动)检测法,用于同时检测梅毒患者血清中的非梅毒螺旋体和梅毒螺旋体抗体。

方法

该检测方法快速、廉价,且对解释结果的专业知识要求有限。该检测基于免疫滤过原理,在通过式装置的膜上点有两种抗原和对照物质。阳性检测的特征是在 2-10 分钟内出现三个红色/品红色斑点。

结果

使用流动检测法、快速血浆反应素(RPR)检测法和梅毒螺旋体被动颗粒凝集检测(TPPA)对来自佐治亚州公共卫生实验室的 376 份存档血清样本进行了检测。与 RPR 检测相比,非梅毒螺旋体斑点的灵敏度和特异性分别为 96.5%和 97.7%,而梅毒螺旋体斑点的灵敏度和特异性分别为 97.3%和 99.1%与 TPPA 检测相比。此外,当对 104 份已知分期梅毒病例血清、49 份非梅毒疾病血清和 23 份已知生物学假阳性反应血清进行平行检测时,该检测与对照检测结果相当。

结论

这些结果表明,双梅毒螺旋体和非梅毒螺旋体检测法可作为在偏远或资源匮乏地区进行梅毒血清学诊断的初筛和确证检测方法,这些地区需要在初次就诊时提供咨询和治疗。

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