660d1050a1eef20749f94d8ffd5478bf pmc_11509444.pdf 9f78908fedaae63f58297a879b039eb8f380613c pmc_11509444.pdf 84d6a6fbb4aeb82ba4f82d0267fb72e4e0c2306010d3e17d284f9d608c9a8d94 pmc_11509444.pdf Title: Assessment of Alinity s Chagas® as a Primary Diagnostic Test for Chronic Chagas Disease in a Non-Endemic Area of Europe (Barcelona, Spain) Subject: 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. Keywords: Alinity s Chagas; Architect Chagas; chronic Chagas disease; Europe; serology; Spain Author: Alba Abras, Cristina Ballart, Anna Fernández-Arévalo, Teresa Llovet, Montserrat Gállego and Carmen Muñoz Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Fri Oct 11 13:57:53 2024 CEST ModDate: Fri Oct 11 14:00:05 2024 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 8 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 772140 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- GIFXFT+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 ETLTRG+URWPalladioL-Bold Type 1 Custom yes yes yes 16 0 KPVFFS+URWPalladioL-Roma Type 1 Custom yes yes yes 22 0 AVTIGF+URWPalladioL-Ital Type 1 Custom yes yes yes 27 0 IKKWKP+CMSY10 Type 1 Builtin yes yes yes 32 0 XMESMT+VnURWPalladioL Type 1 Custom yes yes yes 37 0 PJCGLK+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 54 0 OVNEXW+EURM10 Type 1 Builtin yes yes yes 74 0 IABKIP+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 82 0 IABKJA+PalatinoLinotype CID TrueType Identity-H yes yes yes 85 0 IABKJB+PalatinoLinotype TrueType WinAnsi yes yes no 91 0 IABKJD+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 94 0 IABLEA+PalatinoLinotype TrueType MacRoman yes yes no 97 0 IABKIP+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 107 0 IABKJA+PalatinoLinotype CID TrueType Identity-H yes yes yes 110 0 IABKJB+PalatinoLinotype TrueType WinAnsi yes yes no 116 0 IABKJD+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 119 0 IABLEA+PalatinoLinotype TrueType MacRoman yes yes no 122 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2025-02-06 02:46:55 CET RepresentationInformation: pmc_11509444.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2025-02-04 02:23:51 CET Size: 772140 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 281 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Item: Title: Results Destination: section.3 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: section.6 Info: Title: Assessment of Alinity s Chagas® as a Primary Diagnostic Test for Chronic Chagas Disease in a Non-Endemic Area of Europe (Barcelona, Spain) Author: Alba Abras, Cristina Ballart, Anna Fernández-Arévalo, Teresa Llovet, Montserrat Gállego and Carmen Muñoz Subject: 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. 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