Memorias do Instituto Oswaldo Cruz · 2025
A multicentre comparative study of serological methods for diagnosing Chagas disease in Brazil.
СтатьяМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
BACKGROUND: 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.
OBJECTIVES: This multicentre study assessed the diagnostic performance of 17 serological assays for detecting anti-T. cruzi antibodies.
METHODS: 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.
FINDINGS: 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.
MAIN CONCLUSIONS: 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.
OBJECTIVES: This multicentre study assessed the diagnostic performance of 17 serological assays for detecting anti-T. cruzi antibodies.
METHODS: 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.
FINDINGS: 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.
MAIN CONCLUSIONS: 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.