ARCHITECT Chagas® as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting (Barcelona, Spain)

A. Abras, C. Ballart, A. Fernández-Arévalo, T. Llovet, M. Gállego, C. Muñoz*

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

2 Citations (Scopus)

Abstract

Objectives: To evaluate two algorithms for the diagnosis of chronic and congenital Chagas disease (CD), both including the chemiluminescent microparticle immunoassay ARCHITECT Chagas® (CMIA) as a single test but with an amended signal-to-cut-off ratio (S/CO) of ≥6, instead of an S/CO of ≥1 as indicated by the manufacturer. Methods: The study encompassed two panels of retrospective samples: 831 sera from 786 adolescents and adults (panel A), and 96 sera from 35 newborn infants with CD-infected mothers (panel B). A CMIA-negative result was deemed conclusive, whereas samples with an S/CO ≥ 0.8 were confirmed by a second test (BioELISA Chagas, ELISAr). Results: In panel A, seropositivity was 13% (102/786); 10 samples gave discordant results for CMIA and ELISAr, all of which were CMIA positive and had CD confirmed through a previous diagnosis by two positive serological tests. In panel B, all newborns were considered non-infected based on both a progressive decrease in antibody titres over time and negative real-time PCR results. CMIA still gave positive results in two infants aged 10 months but no S/CO values ≥6 were observed from 4 months on. Conclusions: CMIA is a firm candidate for use as a single CD diagnostic test in non-endemic countries. The algorithm with the ≥6 S/CO is as an efficient method for chronic CD diagnosis. CMIA could also be used as a single test to screen infants for congenital infection at the age of 10 months or even earlier if applying the corrected cut-off ratio, although further studies are required.

Original languageAmerican English
JournalClinical Microbiology and Infection
DOIs
Publication statusPublished - 1 Jul 2020

Keywords

  • ARCHITECT Chagas®
  • Chagas disease
  • Serology
  • Spain
  • Trypanosoma cruzi

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