Ostermayer Alejandro Luquetti, Medeiros Fernanda Alvarenga Cardoso, Iturra Jacqueline Araújo Domingos, de Souza Filho Job Alves, Leony Leonardo Maia, Vasconcelos Larissa de Carvalho Medrado, Siriano Liliane da Rocha, Tavares Suelene Brito do Nascimento, Belo Vinícius Silva, de Sousa Andréa Silvestre, Santos Fred Luciano Neves
Universidade Federal de Goiás, Hospital Universitário, Núcleo de Estudos em Doença de Chagas, Goiânia, GO, Brasil.
Fundação Ezequiel Dias, Serviço de Doenças Parasitárias, Belo Horizonte, MG, Brasil.
Mem Inst Oswaldo Cruz. 2025 Jun 13;120:e240282. doi: 10.1590/0074-02760240282. eCollection 2025.
Chagas disease (CD), a neglected tropical disease caused by Trypanosoma cruzi, remains a significant often underdiagnosed public health challenge in endemic regions, affecting millions globally. Accurate and timely diagnosis is critical, but the performance of existing diagnostic methods varies widely in sensitivity and specificity.
This multicentre study assessed the diagnostic performance of 17 serological assays for detecting anti-T. cruzi antibodies.
Commercial enzyme immunoassays (EIA), indirect haemagglutination assays (IHA), indirect immunofluorescence assays (IIF), rapid diagnostic tests (RDT), and a chemiluminescent microparticle immunoassay (CMIA) were included in this study.
Some EIA-based tests achieved 100% sensitivity, while IHAs and IIFs demonstrated reduced specificity. CMIA exhibited 100% sensitivity, highlighting its potential as a robust screening tool. Combining EIAs with IHAs or IIFs improved overall sensitivity, often surpassing 99%, although specificity remained variable. Cross-reactivity with other parasitic diseases posed challenges to specificity, particularly in assays employing crude antigens.
These findings emphasise the importance of tailoring diagnostic tool selection to regional epidemiological contexts and advancing antigen refinement to enhance diagnostic accuracy and accessibility, particularly in resource-limited settings.
恰加斯病（CD）是由克氏锥虫引起的一种被忽视的热带病，在流行地区仍然是一个重大的、常常未被诊断出来的公共卫生挑战，全球数百万人受到影响。准确及时的诊断至关重要，但现有诊断方法的性能在敏感性和特异性方面差异很大。
这项多中心研究评估了17种血清学检测方法检测抗克氏锥虫抗体的诊断性能。
本研究纳入了商业酶免疫测定法（EIA）、间接血凝测定法（IHA）、间接免疫荧光测定法（IIF）、快速诊断检测法（RDT）和化学发光微粒子免疫测定法（CMIA）。
一些基于EIA的检测方法灵敏度达到100%，而IHA和IIF的特异性有所降低。CMIA的灵敏度为100%，凸显了其作为一种强大筛查工具的潜力。将EIA与IHA或IIF结合可提高总体灵敏度，通常超过99%，不过特异性仍存在差异。与其他寄生虫病的交叉反应给特异性带来了挑战，尤其是在使用粗抗原的检测方法中。
这些发现强调了根据区域流行病学情况选择诊断工具以及推进抗原提纯以提高诊断准确性和可及性的重要性，特别是在资源有限的环境中。
