Abstract：
Chagas disease (CD), caused by the protozoan Trypanosoma cruzi, is an important problem of public health even in regions where it is not endemic. Spain ranks second worldwide in terms of imported cases of T. cruzi infection in the chronic phase. The diagnosis in this stage is made via the detection of antibodies against T. cruzi. Therefore, we aimed to evaluate the sensitivity and specificity of two fully automated chemiluminescence immunoassays, Chagas VirClia® (CHR), which uses a mixture of recombinant antigens, and Chagas TESA VirClia® (TESA), the first chemiluminescence assay based on excretion-secretion antigens of trypomastigotes, both designed in monotest format. A retrospective case-control study was performed using 105 well-characterized samples: 49 from patients with CD, 22 from uninfected individuals, and 32 from patients with other pathologies. Sensitivity was 98% for CHR and 92% for TESA. In contrast, the specificity in both was 100%. Cross-reactivity was observed in leishmaniasis (2/10). CHR meets the criteria to become a tool for serological screening, while TESA has the potential for confirmation and cross-reaction discrimination. The monotest format allows its application in laboratories with a small number of samples. The high specificity of both assays is useful in areas where leishmaniasis is endemic.
摘要：
恰加斯病（CD），由原生动物克氏锥虫引起的，是公共卫生的一个重要问题，即使在非地方病的地区也是如此。西班牙在慢性期输入克氏虫感染病例方面排名世界第二。该阶段的诊断是通过检测针对克氏锥虫的抗体来进行的。因此,我们旨在评估两种全自动化学发光免疫测定的敏感性和特异性，ChagasVirClia®(CHR),使用重组抗原的混合物，和ChagasTESAVirClia®（TESA），第一个基于锥虫排泄分泌抗原的化学发光测定法，两者都以最单调的格式设计。使用105个特征明确的样本进行了回顾性病例对照研究：49个来自CD患者，22名来自未感染的人，32名来自其他疾病患者。CHR的敏感性为98%，TESA的敏感性为92%。相比之下,两者的特异性均为100%.在利什曼病中观察到交叉反应性(2/10)。CHR符合标准，成为血清学筛查的工具，而TESA具有确认和交叉反应区分的潜力。最单调的格式允许其在具有少量样品的实验室中的应用。两种测定的高特异性在利什曼病流行的地区是有用的。
