BACKGROUND Chagas disease, resulting from Trypanosoma cruzi infections, continues to be a health concern mainly in Latin American countries where the parasite is endemic. The laboratory diagnosis of a chronic infection is determined through serological assays for antibodies against T. cruzi and several tests are available that differ in key components, formats and methodologies. To date, no single test meets the criteria of a gold standard. The situation is further complicated by the difficulties associated with performance comparisons between different immunoassays or methodologies executed at different times and geographical areas. OBJECTIVE To improve the diagnosis of Chagas disease, the WHO coordinated the development of two International Biological Reference Standards for antibodies against anti-T. cruzi: NIBSC 09/186 and NIBSC 09/188 that respectively represent geographical regions with the highest prevalence of TcII and TcI lineages of the parasite. METHODS The principle goal of this study was to verify the behavior of these standards when assayed by several commercially available serological tests that employ different methods to capture and detect human anti-T. cruzi antibodies. FINDINGS AND MAIN CONCLUSIONS The results reinforce the recommendation that these standards be considered for performance evaluations of commercialised immunoassays and should be an integral step in the development of new test components or assay paradigms.

中文翻译：

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应用世界卫生组织国际生物参考标准评估慢性恰加斯病的商业血清学检测。

背景技术 由克氏锥虫感染引起的南美锥虫病仍然是一个主要在该寄生虫流行的拉丁美洲国家的健康问题。慢性感染的实验室诊断是通过克氏锥虫抗体的血清学测定来确定的，并且有几种在关键成分、形式和方法上有所不同的测试。迄今为止，还没有任何一项测试符合黄金标准的标准。由于在不同时间和地理区域执行的不同免疫测定或方法之间的性能比较相关的困难，情况变得更加复杂。目的 为了改善恰加斯病的诊断，世界卫生组织协调制定了两项针对抗锥虫病抗体的国际生物参考标准。cruzi：NIBSC 09/186 和 NIBSC 09/188 分别代表寄生虫 TcII 和 TcI 谱系流行率最高的地理区域。方法 本研究的主要目标是验证这些标准品在通过几种市售血清学测试进行测定时的行为，这些测试采用不同的方法来捕获和检测人类抗 T 蛋白。克鲁兹抗体。结果和主要结论结果强化了这样的建议：考虑将这些标准用于商业化免疫测定的性能评估，并且应该成为开发新测试组件或测定范例的一个不可或缺的步骤。