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首页> 美国卫生研究院文献>Clinical and Diagnostic Laboratory Immunology >Evaluation of the Bio-Rad BioPlex 2200 Syphilis Multiplex Flow Immunoassay for the Detection of IgM- and IgG-Class Antitreponemal Antibodies
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Evaluation of the Bio-Rad BioPlex 2200 Syphilis Multiplex Flow Immunoassay for the Detection of IgM- and IgG-Class Antitreponemal Antibodies

机译：评估Bio-Rad BioPlex 2200梅毒多重流免疫分析法用于检测IgM和IgG类抗梯蛋白抗体的能力

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The laboratory diagnosis of syphilis is based primarily upon serologic findings. Historically, serologic testing for syphilis has relied on assays such as rapid plasma reagin, fluorescent treponemal antibody absorption, Treponema pallidum particle agglutination (TP-PA), and more recently, enzyme immunoassay (EIA). In this study, we evaluated the performance of a novel multiplex flow immunoassay (BioPlex 2200 Syphilis; Bio-Rad Laboratories, Hercules, CA) for the detection of antitreponemal IgG- and IgM-class antibodies. Serum specimens (n = 1,008) submitted for routine treponema-specific antibody testing by syphilis IgM and IgG EIA (Trep-Chek; Phoenix-Biotech, Mississauga, Ontario, Canada) were also analyzed by the BioPlex Syphilis multiplex assay. Specimens showing discordant results were repeat tested, with further discrepancies being arbitrated by TP-PA. Compared directly to the results of EIA, the BioPlex IgG assay demonstrated 98.7% (77/78) sensitivity and 99.4% (916/930) specificity. Compared to the Trep-Chek IgM EIA, the BioPlex IgM assay showed 80% (4/5) sensitivity and 97.9% (652/666) specificity. These results indicate that the BioPlex Syphilis multiplex assay shows similar serological agreement with EIA while allowing for a fully automated random-access platform that provides faster (1.7 h for 100 samples versus 4.5 h by EIA) and higher-throughput (800 samples per 9 h versus 200 samples by EIA) analysis of the syphilis serologic response.
机译：梅毒的实验室诊断主要基于血清学发现。从历史上看，梅毒的血清学检测依赖于诸如快速血浆反应素，荧光性螺旋体抗体吸收，梅毒螺旋体颗粒凝集（TP-PA）等检测方法，最近还依赖于酶免疫法（EIA）。在这项研究中，我们评估了新型多重流免疫测定（BioPlex 2200 Syphilis； Bio-Rad Laboratories，Hercules，CA）用于检测抗梯状IgG和IgM类抗体的性能。还通过BioPlex Syphilis多重分析法分析了通过梅毒IgM和IgG EIA（Trep-Chek； Phoenix-Biotech，密西沙加，加拿大安大略省）提交的用于常规梅毒螺旋体特异性抗体测试的血清样本（n = 1,008）。重复测试显示出不一致结果的标本，进一步的差异由TP-PA裁定。与EIA的结果直接比较，BioPlex IgG分析显示出98.7％（77/78）的敏感性和99.4％（916/930）的特异性。与Trep-Chek IgM EIA相比，BioPlex IgM分析显示出80％（4/5）的敏感性和97.9％（652/666）的特异性。这些结果表明，BioPlex Syphilis多重分析显示与EIA具有相似的血清学一致性，同时提供了一种全自动随机访问平台，该平台可提供更快的速度（100个样品为1.7小时，EIA为4.5小时）和更高的通量（每9小时800个样品）对比EIA分析的200个样本）梅毒血清反应的分析。

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