Assessment of Alinity s Chagas ® as a Primary Diagnostic Test for Chronic Chagas Disease in a Non-Endemic Area of Europe (Barcelona, Spain)
Abras, Alba (Universitat de Girona. Departament de Biologia)
Ballart, Cristina (Universitat de Barcelona. Departament de Biologia)
Fernández-Arévalo, Anna (Universitat de Barcelona. Departament de Biologia)
Llovet, Teresa (Institut de Recerca Sant Pau)
Gállego Culleré, Montserrat (Universitat de Barcelona. Departament de Biologia)
Muñoz-Batet, Carmen (Institut de Recerca Sant Pau)

Data:	2024
Resum:	Chagas disease (CD) has become a worldwide problem due to globalization. In Europe, most cases are imported and are diagnosed in the chronic phase by two serological tests, as recommended by the World Health Organization. Chemiluminescent microparticle immunoassays (CMIAs) are an emerging alternative to the diagnostic standard. We aimed to validate the CMIA Alinity s Chagas ® as a primary diagnostic test for chronic CD following its replacement of Architect Chagas ®, with an amended signal-to-cut-off (S/CO) ratio of ≥6. Laboratory results and clinical data were collected retrospectively from 774 sera from an at-risk population tested for CD in Barcelona during 2020-2022. Negative results required no further testing, and those with a S/CO ratio ≥ 0. 8 were confirmed by a second serological assay, according to the common practice. Four per cent of the samples (31/774) were determined to be seropositive by Alinity s, 93. 5% of which (29/31) had an S/CO ratio ≥ 6. Almost all the samples could be directly classified by the corrected S/CO. Alinity s Chagas ® was validated as a single test for chronic CD diagnosis by raising the S/CO to ≥6. Its implementation could provide faster results and help reduce CD underdiagnosis in non-endemic countries.
Ajuts:	Agència de Gestió d'Ajuts Universitaris i de Recerca 2021/SGR-01562
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Alinity s Chagas ; Architect Chagas ; Chronic Chagas disease ; Europe ; Serology ; Spain
Publicat a:	Life, Vol. 14 (october 2024) , ISSN 2075-1729

DOI: 10.3390/life14101278
PMID: 39459578

8 p, 754.0 KB

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