Cross-Reactivity Using Chimeric Trypanosoma cruzi Antigens: Diagnostic Performance in Settings Where Chagas Disease and American Cutaneous or Visceral Leishmaniasis Are Coendemic

Daltro, Ramona Tavares; Leony, Leonardo Maia; Freitas, Natália Erdens Maron; Silva, Ângelo Antônio Oliveira; Santos, Emily Ferreira dos; Del-Rei, Rodrigo Pimenta; Brito, Maria Edileuza Felinto de; Brandão-Filho, Sinval Pinto; Gomes, Yara M.; Silva, Marcelo S.; Donato, Silvia; Jerônimo, Selma M. B.; Monteiro, Gloria Regina de Góis; Carvalho, Lucas P.; Magalhães, Ana Paula Nogueira de; Zanchin, Nilson Ivo Tonin; Celedón, Paola Alejandra Fiorani; Santos, Fred Luciano Neves

doi:10.1128/jcm.00762-19

Cited by 40 publications

(57 citation statements)

References 37 publications

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“…Inconclusive results using this panel were statistically insignificant, except to IBMP-8.1. These findings are similar to previous results obtained when our group assessed the cross-reactivity in human samples for pathogens of medical interest, such as dengue, B and C hepatitis, HIV, HTLV, visceral and cutaneous leishmaniasis, leptospirosis, rubella, measles, schistosomiasis, and syphilis using both ELISA and liquid microarray [19,20,26]. The low number of cross-reaction suggests that IBMP antigens, specially IBMP-8.3, can be safely used to diagnose canine T .…”

Section: Discussionsupporting

confidence: 90%

“…These antigens presented high levels of sensitivity, specificity, and accuracy for samples from both endemic and non-endemic areas for several geographic regions [19,24,25]. Cross-reactivity has already been evaluated and only a small number of samples were classified as reagent for various infectious diseases of clinical interest, including leishmaniasis [19,26]. The results obtained for human samples are very promising.…”

Section: Introductionmentioning

confidence: 99%

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Performance of recombinant chimeric proteins in the serological diagnosis of Trypanosoma cruzi infection in dogs

Leony

Freitas

Del-Rei³

et al. 2019

PLoS Negl Trop Dis

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Background Dogs are considered sentinels in areas of Trypanosoma cruzi transmission risk to humans. ELISA is generally the method of choice for diagnosing T . cruzi exposure in dogs, but its performance substantially depends on the antigenic matrix employed. In previous studies, our group has developed four chimeric antigens (IBMP-8.1, 8.2, 8.3, and 8.4) and evaluated their potential for diagnosing T . cruzi exposure in humans. For human sera, these chimeric antigens presented superior diagnostic performances as compared to commercial tests available in Brazil, Spain, and Argentina. Therefore, in this study we have evaluated the potential of these antigenic proteins for detection of anti- T . cruzi IgG antibodies in dog sera. Methodology/Principal findings The IBMP-ELISA assays were optimized by checkerboard titration. Subsequently, the diagnostic potential was validated through analysis of ROC curves and the performance of the tests was determined using double entry tables. Cross-reactivity was also evaluated for babesiosis, ehrlichiosis, dirofilariosis, anaplasmosis, and visceral leishmaniasis. Best performance was shown by IBMP-8.3 and IBMP-8.4, although all four antigens demonstrated a high diagnostic performance with 46 positive and 149 negative samples tested. IBMP-8.3 demonstrated 100% sensitivity, followed by IBMP-8.4 (96.7–100%), IBMP-8.2 (73.3–87.5%), and IBMP-8.1 (50–100%). The highest specificities were achieved with IBMP-8.2 (100%) and IBMP-8.4 (100%), followed by IBMP-8.3 (96.7–97.5%) and IBMP 8.1 (89.1–100%). Conclusions/Significance The use of chimeric antigenic matrices in immunoassays for anti- T . cruzi IgG antibody detection in sera of infected dogs was shown to be a promising tool for veterinary diagnosis and epidemiological studies. The chimeric antigens used in this work allowed also to overcome the common hurdles related to serodiagnosis of T . cruzi infection, especially regarding variation of efficiency parameters according to different strains and cross-reactivity with other infectious diseases.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Performance of recombinant chimeric proteins in the serological diagnosis of Trypanosoma cruzi infection in dogs

Leony

Freitas

Del-Rei³

et al. 2019

PLoS Negl Trop Dis

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“…Additionally, these chimeric proteins have shown a negligible cross-reactivity with both American cutaneous and visceral leishmaniasis, demonstrating their utility in regions where T. cruzi and Leishmania spp. are coendemic [21]. In all previous studies, we observed that the IBMP-8.1 and IBMP-8.4 antigens yielded the highest performance values among the evaluated antigens.…”

Section: Introductionsupporting

confidence: 50%

Development of a New Lateral Flow Assay Based on IBMP-8.1 and IBMP-8.4 Chimeric Antigens to Diagnose Chagas Disease

Silva

Santos

et al. 2020

BioMed Research International

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Despite several available methodologies for Chagas disease (CD) serological screening, the main limitation of chronic CD diagnosis is the lack of effective tools for large-scale screening and point-of-care diagnosis to be used in different CD epidemiological scenarios. Taking into account that developing such a diagnostic tool will significantly improve the ability to identify CD carriers, we aimed at performing a proof-of-concept study (phase I study) to assess the use of these proteins in a point-of-care platform using serum samples from different geographical settings of Brazil and distinct clinical presentations. The diagnostic accuracy study was conducted on a panel of two WHO International Standards (IS) and 14 sera from T. cruzi-positive and 16 from T. cruzi-negative individuals. The results obtained with the test strips were converted to digital images, allowing quantitative comparison expressed as a relative band intensity ratio (RBI). The diagnostic potential and performance were also determined. Regardless of the geographical origin or clinical presentation, all sera with T. cruzi antibodies returned positive both for IBMP-8.1 and IBMP-8.4 chimeric antigens. The area under the ROC curve (AUC) values was 100% for both antigens, demonstrating an outstanding overall diagnostic accuracy (100%). Based on the data, we believe that the lateral flow assays based on these antigens are promising methodologies for screening CD.

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“…Indeed, this value was slightly increased because of the inclusion of sera from individuals infected with Leishmania (CMIA S/CO of up to 4.57). Alternatively, a posterior study proposed a S/CO !3.80 [16], which according to our results would be too low to discriminate against cross-reactions with Leishmania species, a common problem in areas where both trypanosomatids co-exist [27]. The S/CO value !6 was supported by another subsequent study, in which its application confirmed about 10% of all samples [18].…”

Section: Discussionmentioning

confidence: 57%

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

Abràs

Ballart

Fernández-Arévalo

et al. 2021

Clinical Microbiology and Infection

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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 CMIAnegative 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.

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Cross-Reactivity Using Chimeric Trypanosoma cruzi Antigens: Diagnostic Performance in Settings Where Chagas Disease and American Cutaneous or Visceral Leishmaniasis Are Coendemic

Cited by 40 publications

References 37 publications

Performance of recombinant chimeric proteins in the serological diagnosis of Trypanosoma cruzi infection in dogs

Performance of recombinant chimeric proteins in the serological diagnosis of Trypanosoma cruzi infection in dogs

Development of a New Lateral Flow Assay Based on IBMP-8.1 and IBMP-8.4 Chimeric Antigens to Diagnose Chagas Disease

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

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