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Parasitology

Comparative Evaluation of 11 Commercialized Rapid Diagnostic Tests for Detecting Trypanosoma cruzi Antibodies in Serum Banks in Areas of Endemicity and Nonendemicity

Claudia L. Sánchez-Camargo, Pedro Albajar-Viñas, Patricia P. Wilkins, Javier Nieto, David A. Leiby, Luc Paris, Karenina Scollo, Carolina Flórez, Carmen Guzmán-Bracho, Alejandro O. Luquetti, Nidia Calvo, Kenji Tadokoro, Amadeo Saez-Alquezar, Pedro Pablo Palma, Miguel Martin, Laurence Flevaud
P. H. Gilligan, Editor
Claudia L. Sánchez-Camargo
aMédecins Sans Frontières Operational Center Barcelona-Athens (OCBA), Barcelona, Spain
bUniversitat Autónoma de Barcelona, Grups de Recerca d'Amèrica i Àfrica Llatines (GRAAL), Barcelona, Spain
oUniversidad Antonio Nariño (UAN), Bogotá, Colombia
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Pedro Albajar-Viñas
cWHO–Program on Control of Chagas Disease, Department of Control of Neglected Tropical Diseases, Geneva, Switzerland
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Patricia P. Wilkins
dCenters for Disease Control and Prevention (CDC), Atlanta, Georgia, USA
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Javier Nieto
eInstituto Salud Carlos III (ISCIII), Madrid, Spain
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David A. Leiby
fAmerican Red Cross, Holland Laboratory, Rockville, Maryland, USA
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Luc Paris
gAP–HP Hopital Pitié-Salpêtrière, Paris, France
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Karenina Scollo
hDepartamento de Diagnóstico, Instituto Nacional de Parasitología Dr. Mario Fatala Chabén, Buenos Aires, Argentina
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Carolina Flórez
iInstituto Nacional de Salud (INS), Bogotá, Colombia
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Carmen Guzmán-Bracho
jInstituto de Diagnóstico y Referencia Epidemiológicos (InDRE), Mexico City, Mexico
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Alejandro O. Luquetti
kHospital das Clínicas, Universidade Federal de Goiás, Goiás, Brazil
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Nidia Calvo
lCentro Nacional de Referencia en Parasitología (CNRP), INCIENSA, Tres Rios, Costa Rica
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Kenji Tadokoro
mCentral Blood Institute, Blood Service Headquarters, Japanese Red Cross Society, Tokyo, Japan
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Amadeo Saez-Alquezar
nPrograma Nacional de Controle de Qualidade (PNCQ), Río de Janeiro, Brazil
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Pedro Pablo Palma
aMédecins Sans Frontières Operational Center Barcelona-Athens (OCBA), Barcelona, Spain
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Miguel Martin
bUniversitat Autónoma de Barcelona, Grups de Recerca d'Amèrica i Àfrica Llatines (GRAAL), Barcelona, Spain
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Laurence Flevaud
aMédecins Sans Frontières Operational Center Barcelona-Athens (OCBA), Barcelona, Spain
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P. H. Gilligan
Roles: Editor
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DOI: 10.1128/JCM.00144-14
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ABSTRACT

Chagas disease is one of the main public health issues in Latin America. Increasingly during the past few decades, Trypanosoma cruzi infection has been detected in North America, Europe, and the Western Pacific, mainly as a result of population movement. The limited availability of rapid serological diagnostic tests hinders rapid diagnosis and early treatment in areas of endemicity and nonendemicity. In collaboration with 11 national reference laboratories (NRLs) from different geographical areas, we evaluated the performances of commercialized serological rapid diagnostic tests (RDT) for T. cruzi infection. Eleven commercialized T. cruzi infection RDTs were evaluated on a total of 474 samples extensively tested with at least three different techniques for Chagas disease, maintained at controlled low temperatures, and stored in the serum banks of the 11 NRLs. We measured the sensitivity, specificity, and concordance of each RDT and provided an additional questionnaire to evaluate its ease of use. The selected RDTs in this study were performed under controlled laboratory conditions. Out of the 11 RDTs, we found 8 of them to be useful, with the cassette format favored over the strip. We did not observe significant differences in RDT performances in the different regions. Overall, the performance results were lower than those disclosed by the manufacturers. The results of this evaluation validate the possibility of using RDTs to diagnose Chagas disease, thereby decreasing the time to treatment at a primary health care facility for patients who are willing to be treated. Further studies should be conducted in the laboratory and in the field to confirm these data, expressly to evaluate reproducibility in resource-limited settings, or using whole blood in clinical settings in areas of endemicity and nonendemicity.

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Comparative Evaluation of 11 Commercialized Rapid Diagnostic Tests for Detecting Trypanosoma cruzi Antibodies in Serum Banks in Areas of Endemicity and Nonendemicity
Claudia L. Sánchez-Camargo, Pedro Albajar-Viñas, Patricia P. Wilkins, Javier Nieto, David A. Leiby, Luc Paris, Karenina Scollo, Carolina Flórez, Carmen Guzmán-Bracho, Alejandro O. Luquetti, Nidia Calvo, Kenji Tadokoro, Amadeo Saez-Alquezar, Pedro Pablo Palma, Miguel Martin, Laurence Flevaud
Journal of Clinical Microbiology Jun 2014, 52 (7) 2506-2512; DOI: 10.1128/JCM.00144-14

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Comparative Evaluation of 11 Commercialized Rapid Diagnostic Tests for Detecting Trypanosoma cruzi Antibodies in Serum Banks in Areas of Endemicity and Nonendemicity
Claudia L. Sánchez-Camargo, Pedro Albajar-Viñas, Patricia P. Wilkins, Javier Nieto, David A. Leiby, Luc Paris, Karenina Scollo, Carolina Flórez, Carmen Guzmán-Bracho, Alejandro O. Luquetti, Nidia Calvo, Kenji Tadokoro, Amadeo Saez-Alquezar, Pedro Pablo Palma, Miguel Martin, Laurence Flevaud
Journal of Clinical Microbiology Jun 2014, 52 (7) 2506-2512; DOI: 10.1128/JCM.00144-14
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