Identification of sVSG117 as an Immunodiagnostic Antigen and Evaluation of a Dual-Antigen Lateral Flow Test for the Diagnosis of Human African Trypanosomiasis
Identification of sVSG117 as an Immunodiagnostic Antigen and Evaluation of a Dual-Antigen Lateral Flow Test for the Diagnosis of Human African Trypanosomiasis
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DOI：
10.1371/journal.pntd.0002976
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发表时间：
2014-07-01
影响因子：
3.8
通讯作者：
Ferguson, Michael A. J.
中科院分区：
文献类型：
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作者：
Sullivan, Lauren;Fleming, Jennifer;Ferguson, Michael A. J.
背景资料：由布氏冈比亚锥虫引起的非洲人锥虫病（HAT）的诊断主要依靠锥虫卡凝集试验（CATT）。目前尚无T. B.罗得西亚语我们的主要目的是开发一个原型的侧流试验，可能是一个改进CATT.Methodology/Principle调查结果：感染和对照血清的感染和对照血清中筛选对四个不同的可溶性形式的变体表面糖蛋白（sVSGs）的ELISA和一个，sVSG 117，表现出特别强的免疫反应性汇集感染血清。使用个体血清，sVSG 117显示能够区分T. B.用ELISA和侧流试验检测冈比亚按蚊感染血清和对照血清。随后将sVSG 117抗原与先前描述的重组诊断抗原rISG 65一起使用，以创建双抗原侧向流测试原型。结论：在虚拟现场试验中，以两条阳性抗原条带作为感染标准，sVSG 117和rISG 65双抗原侧流试验原型的敏感性为97.3%。（95% CI：93.3 ~ 99.2），特异性为83.3%（95% CI：76.4 ~ 88.9）。B.冈比亚感染。该装置对于检测T. B.以两条阳性抗原带作为感染标准，检测罗得西亚杆菌感染的敏感性为58.9%（95%CI：44.9 ~ 71.9），特异性为97.3%（95%CI：90.7 ~ 99.7）。然而，使用一条或两条阳性抗原带作为T. B.罗得西亚菌感染的敏感性提高到83.9%（95%CI：71.7至92.4），特异性为85.3%（95%CI：75.3至92.4）。这些结果鼓励进一步开发用于临床使用的双抗原装置。
Background: The diagnosis of human African trypanosomiasis (HAT) caused by Trypanosoma brucei gambiense relies mainly on the Card Agglutination Test for Trypanosomiasis (CATT). There is no immunodiagnostic for HAT caused by T. b. rhodesiense. Our principle aim was to develop a prototype lateral flow test that might be an improvement on CATT.Methodology/Principle Findings: Pools of infection and control sera were screened against four different soluble form variant surface glycoproteins (sVSGs) by ELISA and one, sVSG117, showed particularly strong immunoreactivity to pooled infection sera. Using individual sera, sVSG117 was shown to be able to discriminate between T. b. gambiense infection and control sera by both ELISA and lateral flow test. The sVSG117 antigen was subsequently used with a previously described recombinant diagnostic antigen, rISG65, to create a dual-antigen lateral flow test prototype. The latter was used blind in a virtual field trial of 431 randomized infection and control sera from the WHO HAT Specimen Biobank.Conclusion/Significance: In the virtual field trial, using two positive antigen bands as the criterion for infection, the sVSG117 and rISG65 dual-antigen lateral flow test prototype showed a sensitivity of 97.3% (95% CI: 93.3 to 99.2) and a specificity of 83.3% (95% CI: 76.4 to 88.9) for the detection of T. b. gambiense infections. The device was not as good for detecting T. b. rhodesiense infections using two positive antigen bands as the criterion for infection, with a sensitivity of 58.9% (95% CI: 44.9 to 71.9) and specificity of 97.3% (95% CI: 90.7 to 99.7). However, using one or both positive antigen band(s) as the criterion for T. b. rhodesiense infection improved the sensitivity to 83.9% (95% CI: 71.7 to 92.4) with a specificity of 85.3% (95% CI: 75.3 to 92.4). These results encourage further development of the dual-antigen device for clinical use.