First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease

Autores
Ramirez Gomez, Juan Carlos; Parrado, Rudy; Sulleiro, Elena; De La Barra, Anabelle; Rodríguez, Marcelo; Villarroel, Sandro; Irazu, Lucía; Alonso Vega, Cristina; Alves, Fabiana; Curto, Maria de Los Angeles; García, Lineth; Ortiz, Lourdes; Torrico, Faustino; Gascón, Joaquim; Flevaud, Laurence; Molina, Israel; Ribeiro, Isabela; Schijman, Alejandro Gabriel
Año de publicación
2017
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Real-Time PCR (qPCR) testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD), but no external quality assurance (EQA) program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228), a pro-drug of ravuconazole; the Sampling Study (NCT01678599), that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967), that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq.)/mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement) and concordance (between laboratory agreement) for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of CD.
Fil: Ramirez Gomez, Juan Carlos. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: Parrado, Rudy. Universidad Mayor de San Simon; Bolivia
Fil: Sulleiro, Elena. Universitat Autònoma de Barcelona; España
Fil: De La Barra, Anabelle. Universidad Mayor de San Simon; Bolivia
Fil: Rodríguez, Marcelo. Dirección Nacional de Institutos de Investigación. Administración Nacional de Laboratorios e Institutos de Salud. Instituto Nacional de Enfermedades Infecciosas; Argentina
Fil: Villarroel, Sandro. Universidad Mayor de San Simon; Bolivia
Fil: Irazu, Lucía. Dirección Nacional de Institutos de Investigación. Administración Nacional de Laboratorios e Institutos de Salud. Instituto Nacional de Enfermedades Infecciosas; Argentina
Fil: Alonso Vega, Cristina. Drugs for Neglected Diseases initiative; Suiza
Fil: Alves, Fabiana. Drugs for Neglected Diseases initiative; Suiza
Fil: Curto, Maria de Los Angeles. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: García, Lineth. Universidad Mayor de San Simon; Bolivia
Fil: Ortiz, Lourdes. Universidad Autonoma Juan Misael Saracho; Bolivia
Fil: Torrico, Faustino. Fundacion CEADES; Bolivia
Fil: Gascón, Joaquim. Universidad de Barcelona; España
Fil: Flevaud, Laurence. Medecins Sans Frontières Operational Center Barcelona-Athens; España
Fil: Molina, Israel. Universitat Autònoma de Barcelona; España
Fil: Ribeiro, Isabela. Drugs for Neglected Diseases initiative; Suiza
Fil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Materia
External quality assurance;
proficiency testing
Real-Time PCR
Chagas disease
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/66821
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/66821
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas diseaseRamirez Gomez, Juan CarlosParrado, RudySulleiro, ElenaDe La Barra, AnabelleRodríguez, MarceloVillarroel, SandroIrazu, LucíaAlonso Vega, CristinaAlves, FabianaCurto, Maria de Los AngelesGarcía, LinethOrtiz, LourdesTorrico, FaustinoGascón, JoaquimFlevaud, LaurenceMolina, IsraelRibeiro, IsabelaSchijman, Alejandro GabrielExternal quality assurance;proficiency testingReal-Time PCRChagas diseasehttps://purl.org/becyt/ford/1.6https://purl.org/becyt/ford/1Real-Time PCR (qPCR) testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD), but no external quality assurance (EQA) program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228), a pro-drug of ravuconazole; the Sampling Study (NCT01678599), that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967), that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq.)/mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement) and concordance (between laboratory agreement) for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of CD.Fil: Ramirez Gomez, Juan Carlos. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: Parrado, Rudy. Universidad Mayor de San Simon; BoliviaFil: Sulleiro, Elena. Universitat Autònoma de Barcelona; EspañaFil: De La Barra, Anabelle. Universidad Mayor de San Simon; BoliviaFil: Rodríguez, Marcelo. Dirección Nacional de Institutos de Investigación. Administración Nacional de Laboratorios e Institutos de Salud. Instituto Nacional de Enfermedades Infecciosas; ArgentinaFil: Villarroel, Sandro. Universidad Mayor de San Simon; BoliviaFil: Irazu, Lucía. Dirección Nacional de Institutos de Investigación. Administración Nacional de Laboratorios e Institutos de Salud. Instituto Nacional de Enfermedades Infecciosas; ArgentinaFil: Alonso Vega, Cristina. Drugs for Neglected Diseases initiative; SuizaFil: Alves, Fabiana. Drugs for Neglected Diseases initiative; SuizaFil: Curto, Maria de Los Angeles. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: García, Lineth. Universidad Mayor de San Simon; BoliviaFil: Ortiz, Lourdes. Universidad Autonoma Juan Misael Saracho; BoliviaFil: Torrico, Faustino. Fundacion CEADES; BoliviaFil: Gascón, Joaquim. Universidad de Barcelona; EspañaFil: Flevaud, Laurence. Medecins Sans Frontières Operational Center Barcelona-Athens; EspañaFil: Molina, Israel. Universitat Autònoma de Barcelona; EspañaFil: Ribeiro, Isabela. Drugs for Neglected Diseases initiative; SuizaFil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaPublic Library of Science2017-11-27info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/66821Ramirez Gomez, Juan Carlos; Parrado, Rudy; Sulleiro, Elena; De La Barra, Anabelle; Rodríguez, Marcelo; et al.; First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease; Public Library of Science; Plos One; 12; 11; 27-11-2017; 1-151932-6203CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1371/journal.pone.0188550info:eu-repo/semantics/altIdentifier/url/https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0188550info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:49:22Zoai:ri.conicet.gov.ar:11336/66821instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 09:49:22.333CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease
title First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease
spellingShingle First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease
Ramirez Gomez, Juan Carlos
External quality assurance;
proficiency testing
Real-Time PCR
Chagas disease
title_short First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease
title_full First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease
title_fullStr First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease
title_full_unstemmed First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease
title_sort First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease
dc.creator.none.fl_str_mv Ramirez Gomez, Juan Carlos
Parrado, Rudy
Sulleiro, Elena
De La Barra, Anabelle
Rodríguez, Marcelo
Villarroel, Sandro
Irazu, Lucía
Alonso Vega, Cristina
Alves, Fabiana
Curto, Maria de Los Angeles
García, Lineth
Ortiz, Lourdes
Torrico, Faustino
Gascón, Joaquim
Flevaud, Laurence
Molina, Israel
Ribeiro, Isabela
Schijman, Alejandro Gabriel
author Ramirez Gomez, Juan Carlos
author_facet Ramirez Gomez, Juan Carlos
Parrado, Rudy
Sulleiro, Elena
De La Barra, Anabelle
Rodríguez, Marcelo
Villarroel, Sandro
Irazu, Lucía
Alonso Vega, Cristina
Alves, Fabiana
Curto, Maria de Los Angeles
García, Lineth
Ortiz, Lourdes
Torrico, Faustino
Gascón, Joaquim
Flevaud, Laurence
Molina, Israel
Ribeiro, Isabela
Schijman, Alejandro Gabriel
author_role author
author2 Parrado, Rudy
Sulleiro, Elena
De La Barra, Anabelle
Rodríguez, Marcelo
Villarroel, Sandro
Irazu, Lucía
Alonso Vega, Cristina
Alves, Fabiana
Curto, Maria de Los Angeles
García, Lineth
Ortiz, Lourdes
Torrico, Faustino
Gascón, Joaquim
Flevaud, Laurence
Molina, Israel
Ribeiro, Isabela
Schijman, Alejandro Gabriel
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv External quality assurance;
proficiency testing
Real-Time PCR
Chagas disease
topic External quality assurance;
proficiency testing
Real-Time PCR
Chagas disease
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.6
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Real-Time PCR (qPCR) testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD), but no external quality assurance (EQA) program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228), a pro-drug of ravuconazole; the Sampling Study (NCT01678599), that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967), that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq.)/mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement) and concordance (between laboratory agreement) for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of CD.
Fil: Ramirez Gomez, Juan Carlos. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: Parrado, Rudy. Universidad Mayor de San Simon; Bolivia
Fil: Sulleiro, Elena. Universitat Autònoma de Barcelona; España
Fil: De La Barra, Anabelle. Universidad Mayor de San Simon; Bolivia
Fil: Rodríguez, Marcelo. Dirección Nacional de Institutos de Investigación. Administración Nacional de Laboratorios e Institutos de Salud. Instituto Nacional de Enfermedades Infecciosas; Argentina
Fil: Villarroel, Sandro. Universidad Mayor de San Simon; Bolivia
Fil: Irazu, Lucía. Dirección Nacional de Institutos de Investigación. Administración Nacional de Laboratorios e Institutos de Salud. Instituto Nacional de Enfermedades Infecciosas; Argentina
Fil: Alonso Vega, Cristina. Drugs for Neglected Diseases initiative; Suiza
Fil: Alves, Fabiana. Drugs for Neglected Diseases initiative; Suiza
Fil: Curto, Maria de Los Angeles. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: García, Lineth. Universidad Mayor de San Simon; Bolivia
Fil: Ortiz, Lourdes. Universidad Autonoma Juan Misael Saracho; Bolivia
Fil: Torrico, Faustino. Fundacion CEADES; Bolivia
Fil: Gascón, Joaquim. Universidad de Barcelona; España
Fil: Flevaud, Laurence. Medecins Sans Frontières Operational Center Barcelona-Athens; España
Fil: Molina, Israel. Universitat Autònoma de Barcelona; España
Fil: Ribeiro, Isabela. Drugs for Neglected Diseases initiative; Suiza
Fil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
description Real-Time PCR (qPCR) testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD), but no external quality assurance (EQA) program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228), a pro-drug of ravuconazole; the Sampling Study (NCT01678599), that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967), that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq.)/mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement) and concordance (between laboratory agreement) for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of CD.
publishDate 2017
dc.date.none.fl_str_mv 2017-11-27
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/66821
Ramirez Gomez, Juan Carlos; Parrado, Rudy; Sulleiro, Elena; De La Barra, Anabelle; Rodríguez, Marcelo; et al.; First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease; Public Library of Science; Plos One; 12; 11; 27-11-2017; 1-15
1932-6203
CONICET Digital
CONICET
url http://hdl.handle.net/11336/66821
identifier_str_mv Ramirez Gomez, Juan Carlos; Parrado, Rudy; Sulleiro, Elena; De La Barra, Anabelle; Rodríguez, Marcelo; et al.; First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease; Public Library of Science; Plos One; 12; 11; 27-11-2017; 1-15
1932-6203
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
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dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
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instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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