Assessment of Alinity s Chagas® as a Primary Diagnostic Test for Chronic Chagas Disease in a Non-Endemic Area of Europe (Barcelona, Spain)

Abstract

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