Infection by Trypanosoma cruzi (Chagas disease [ChD]) affects around 7 million people in the Americas, most of whom are unaware of their status due to lack of clinical manifestations and poor access to diagnosis. Rapid diagnostic tests (RDTs) are widely used for screening for different infections (HIV, hepatitis B, and syphilis), and their application for ChD would facilitate access to diagnosis, especially in remote areas where health services have scarce resources. We conducted a prospective intervention study in 2018 to evaluate in the field two in vitro RDTs for ChD, authorized by the National Administration of Medicaments, Aliments, and Medical Technologies of Argentina (ANMAT), in areas of endemicity and nonendemicity in Argentina. We recruited 607 volunteers older than 18 years in Salta province and the city of Buenos Aires. The RDTs Ab Standard Diagnostics SD Bioline (SD) and Check Chagas Wiener Lab (WL) were performed in situ with whole-blood samples, and confirmatory serology was done at a reference center. The rate of infection with T. cruzi was 17.8% (108/607). The SD test showed 97.2% sensitivity (95% confidence interval [CI], 93.5 to 100) and 91.7% specificity (95% CI, 96.2 to 99.2%), and the WL test showed 93.4% sensitivity (95% CI, 88.2 to 98.6%) and 99.1% specificity (95% CI, 91.9 to 100%). The sensitivity and specificity for the two RDTs tested were higher than previously reported. These results encourage the use of the tested RDTs in Salta province and for further field studies for the implementation of these RDTs in other epidemiological scenarios. This will be very important to improve access to diagnosis of Chagas and its clinical management as a neglected disease, especially in remote areas with health access barriers.

中文翻译：

---

克氏锥虫感染的快速诊断测试（RDT）：在阿根廷的地方病和非地方病地区对两种注册药盒进行现场评估。

克鲁斯锥虫感染（南美锥虫病[ChD]）影响了大约700万人，由于缺乏临床表现和诊断机会差，大多数人不知道自己的状况。快速诊断测试（RDT）被广泛用于筛查不同的感染（HIV，乙型肝炎和梅毒），将其用于ChD将有助于获得诊断，尤其是在卫生服务资源匮乏的偏远地区。我们于2018年进行了一项前瞻性干预研究，以在实地进行两次体外评估经阿根廷国家药品，食品和医疗技术管理局（ANMAT）授权的ChD RDT，在阿根廷的地方性和非流行性地区。我们在萨尔塔省和布宜诺斯艾利斯市招募了607名18岁以上的志愿者。RDT Ab标准诊断SD生物系（SD）和Check Chagas Wiener Lab（WL）与全血样品一起就地进行，并在参考中心进行了确认性血清学检查。克氏锥虫的感染率是17.8％（108/607）。SD测试显示出97.2％的灵敏度（95％置信区间[CI]，从93.5到100）和91.7％的特异性（95％CI，从96.2到99.2％），而WL测试显示93.4％的灵敏度（95％CI，从88.2至100）。 98.6％）和99.1％的特异性（95％CI，91.9至100％）。所测试的两种RDT的敏感性和特异性均高于先前报道的水平。这些结果鼓励在萨尔塔省使用经过测试的RDT，并在其他流行病学情况下进一步实地研究这些RDT的实施。这对于改善对查加斯病的诊断及其作为被忽视疾病的临床管理非常重要，特别是在存在卫生保健障碍的偏远地区。