TY - JOUR
T1 - ARCHITECT Chagas® as a single test candidate for Chagas disease diagnosis
T2 - evaluation of two algorithms implemented in a non-endemic setting (Barcelona, Spain)
AU - Abras, A.
AU - Ballart, C.
AU - Fernández-Arévalo, A.
AU - Llovet, T.
AU - Gállego, M.
AU - Muñoz, C.
N1 - Copyright © 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - 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.
AB - 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.
KW - ARCHITECT Chagas®
KW - Chagas disease
KW - Serology
KW - Spain
KW - Trypanosoma cruzi
UR - http://www.scopus.com/inward/record.url?scp=85088948653&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/695be2eb-6b70-33d8-8cf0-6482a9f8f2f3/
U2 - 10.1016/j.cmi.2020.07.002
DO - 10.1016/j.cmi.2020.07.002
M3 - Artículo
C2 - 32653657
AN - SCOPUS:85088948653
SN - 1198-743X
JO - Clinical Microbiology and Infection
JF - Clinical Microbiology and Infection
ER -