Comparative Evaluation of 11 Commercialized Rapid Diagnostic Tests for Detecting Trypanosoma cruzi Antibodies in Serum Banks in Areas of Endemicity and Nonendemicity
Comparative Evaluation of 11 Commercialized Rapid Diagnostic Tests for Detecting Trypanosoma cruzi Antibodies in Serum Banks in Areas of Endemicity and Nonendemicity
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DOI：
10.1128/jcm.00144-14
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发表时间：
2014-07-01
影响因子：
9.4
通讯作者：
Flevaud, Laurence
中科院分区：
文献类型：
--
作者：
Sanchez-Camargo, Claudia L.;Albajar-Vinas, Pedro;Flevaud, Laurence
恰加斯病是拉丁美洲的主要公共卫生问题之一。在过去的几十年里，在北美、欧洲和西太平洋地区发现了越来越多的克氏锥虫感染，这主要是人口流动的结果。快速血清学诊断测试的有限性阻碍了地方病和非地方病地区的快速诊断和早期治疗。我们与来自不同地理区域的11个国家参考实验室（NRL）合作，评估了商品化的弓形虫血清学快速诊断试验（RDT）的性能。克氏感染11株商品化T.对总共474个样本进行了克氏感染RDT评估，这些样本采用至少三种不同的恰加斯病技术进行了广泛测试，保存在受控低温下，并储存在11个NRL的血清库中。我们测量了每个RDT的敏感性、特异性和一致性，并提供了一份额外的问卷来评估其易用性。本研究中选定的RDT在受控实验室条件下进行。在11个RDT中，我们发现其中8个是有用的，盒式磁带格式优于条带。我们没有观察到RDT性能在不同地区的显着差异。总体而言，性能结果低于制造商披露的结果。这项评估的结果验证了使用RDTs诊断恰加斯病的可能性，从而减少了愿意接受治疗的患者在初级卫生保健机构接受治疗的时间。应在实验室和现场进行进一步研究，以确认这些数据，明确评估资源有限环境中的重现性，或在地方性和非地方性地区的临床环境中使用全血。
Chagas disease is one of the main public health issues in Latin America. Increasingly during the past few decades, Trypanosoma cruzi infection has been detected in North America, Europe, and the Western Pacific, mainly as a result of population movement. The limited availability of rapid serological diagnostic tests hinders rapid diagnosis and early treatment in areas of endemicity and nonendemicity. In collaboration with 11 national reference laboratories (NRLs) from different geographical areas, we evaluated the performances of commercialized serological rapid diagnostic tests (RDT) for T. cruzi infection. Eleven commercialized T. cruzi infection RDTs were evaluated on a total of 474 samples extensively tested with at least three different techniques for Chagas disease, maintained at controlled low temperatures, and stored in the serum banks of the 11 NRLs. We measured the sensitivity, specificity, and concordance of each RDT and provided an additional questionnaire to evaluate its ease of use. The selected RDTs in this study were performed under controlled laboratory conditions. Out of the 11 RDTs, we found 8 of them to be useful, with the cassette format favored over the strip. We did not observe significant differences in RDT performances in the different regions. Overall, the performance results were lower than those disclosed by the manufacturers. The results of this evaluation validate the possibility of using RDTs to diagnose Chagas disease, thereby decreasing the time to treatment at a primary health care facility for patients who are willing to be treated. Further studies should be conducted in the laboratory and in the field to confirm these data, expressly to evaluate reproducibility in resource-limited settings, or using whole blood in clinical settings in areas of endemicity and nonendemicity.