ARCHITECT Chagas (R) as a single test candidate for Chagas disease diagnosis: evaluation of two algorithms implemented in a non-endemic setting
Por:
Abras, A, Ballart, C, Fernandez-Arevalo, A, Llovet, T, Gallego, M, Munoz, C
Publicada:
1 may 2021
Ahead of Print:
1 abr 2021
Resumen:
Objectives: To evaluate two algorithms for the diagnosis of chronic and congenital Chagas disease (CD), both including the chemiluminescent microparticle immunoassay ARCHITECT Chagas (R) (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. (C) 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Filiaciones:
Abras, A:
Univ Girona, Dept Biol, Lab Ictiol Genet, Girona, Spain
Ballart, C:
Univ Barcelona, Fac Farm & Ciencies Alimentacio, Dept Biol Sanitat & Medi Ambient, Sec Parasitol, Barcelona, Spain
Univ Barcelona, Hosp Clin, Int Hlth Res CRESIB, Barcelona Ctr,ISGlobal, Barcelona, Spain
Fernandez-Arevalo, A:
Univ Barcelona, Fac Farm & Ciencies Alimentacio, Dept Biol Sanitat & Medi Ambient, Sec Parasitol, Barcelona, Spain
Hosp de la Santa Creu & St Pau, Serv Microbiol, Sant Quinti 89, E-08026 Barcelona, Spain
Inst Recerca Biomed St Pau, Barcelona, Spain
Llovet, T:
Hosp de la Santa Creu & St Pau, Serv Microbiol, Sant Quinti 89, E-08026 Barcelona, Spain
Univ Autonoma Barcelona, Dept Genet & Microbiol, Bellaterra, Spain
Gallego, M:
Univ Barcelona, Fac Farm & Ciencies Alimentacio, Dept Biol Sanitat & Medi Ambient, Sec Parasitol, Barcelona, Spain
Univ Barcelona, Hosp Clin, Int Hlth Res CRESIB, Barcelona Ctr,ISGlobal, Barcelona, Spain
Munoz, C:
Hosp de la Santa Creu & St Pau, Serv Microbiol, Sant Quinti 89, E-08026 Barcelona, Spain
Inst Recerca Biomed St Pau, Barcelona, Spain
Univ Autonoma Barcelona, Dept Genet & Microbiol, Bellaterra, Spain
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