Evaluation of a new immunochromatographic test using recombinant antigen B8/1 for the diagnosis of cystic echinococcosis
Evaluation of a new immunochromatographic test using recombinant antigen B8/1 for the diagnosis of cystic echinococcosis
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使用重组抗原 B8/1 的新型免疫层析检测诊断囊型包虫病的评价
DOI：
10.1128/jcm.02157-15
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发表时间：
2015
期刊：
影响因子：
9.4
通讯作者：
Ito A
中科院分区：
文献类型：
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作者：
Santivanez SJ;Rodriguez ML;Rodriguez S;Sako Y;Nkouawa A;Kobayashi Y;Sotomayor AL;Peralta JE;Valcarcel M;Gonzalez AE;Garcia HH;Ito A
囊型包虫病(CE)的诊断建立在通过成像识别包囊(S)的基础上，在临床上主要使用免疫诊断试验作为辅助工具。在用于免疫诊断的抗原中，以往的研究描述了重组抗原B8/1(RAgB)以酶联免疫吸附试验(ELISA)的形式表现良好；然而，在疾病流行的偏远地区，实施ELISA是困难的，因此需要一种更简单、快速和可靠的方法，如免疫层析试验(ICT)。在这项研究中，使用一组来自手术证实的CE患者的50份血清样本，我们比较了ICT和使用rAgB的ELISA法的性能。ICT和ELISA法的总体敏感性无统计学差异(78%对72%；P=0.36)。两个测试之间的总体一致性是中等的(κ=0.41P<；0.01)。对于有肝脏受累的患者(κ=0.65；P<；0.001)和有一个以上包虫病的患者(κ=0.82；P<；0.001)，ICT和ELISA法的符合率很高或几乎完美。此外，对88份正常人(n=20)和其他寄生虫感染患者(n=68)的血清标本进行的特异性分析表明，ICT的特异性为89.8%。ICT和ELISA法在检测细粒棘球绦虫特异性抗体方面具有相似的性能，而且ICT具有高度的特异性，为在农村环境中使用ICT作为筛查工具提供了可能性。
Diagnosis of cystic echinococcosis (CE) is based on the identification of the cyst(s) by imaging, using immunodiagnostic tests mainly as complementary tools in clinical settings. Among the antigens used for immunodiagnosis, previous studies described a good performance of the recombinant antigen B8/1 (rAgB) in an enzyme-linked immunosorbent assay (ELISA) format; however, in remote parts of areas where the disease is endemic, the implementation of an ELISA is difficult, so a more simple, rapid, and reliable method such as the immunochromatographic test (ICT) is required. In this study, using a set of 50 serum samples from patients with surgically confirmed CE, we compared the performance of an ICT and that of an ELISA using the rAgB. The overall sensitivities of ICT and ELISA were not statistically different (78% versus 72%;P= 0.36). The overall agreement between both tests was moderate (κ = 0.41;P< 0.01). Concordance between ICT and ELISA was substantial or almost perfect for patients with liver involvement (κ = 0.65;P< 0.001) and patients with more than one hydatid cyst (κ = 0.82;P< 0.001), respectively. Moreover, specificity analysis using a total of 88 serum samples from healthy individuals (n= 20) and patients (n= 68) with other parasitic infections revealed that ICT had a specificity of 89.8%. ICT and ELISA had similar performance for the detection of specific antibodies to E. granulosus, and ICT had a high specificity, opening the possibility of using ICT as a screening tool in rural settings.